Author: Molly Bryant

Clinical Operations Conferences Roundup: 37 Events that Are Happening in 2021 [UPDATED]

Updated 22 July 2021.

2020 completely rocked the schedule of clinical operations conferences by the efforts to stave off the spread of COVID-19. Nearly every conference went virtual. Now with a vaccine on the horizon, we are all hoping to have at least some face to face clinical trial conferences in 2021.

Most events are still virtual, at least in the early part of 2021. To help you keep track, the ArcheMedX team put together this handy roundup of the top events we have on our annual calendar, along with some specific details to help you find that perfect clinical operations meeting for the upcoming year.

September Events

Event: Clinical Trials in Rare Diseases

Dates: Sept. 14 
Location: Virtual
Cost: Free!

Relevant topics: Rare disease research and clinical trials

As the title suggests, this is not a general clinical operations conference. A lot of the usual topics are covered, from decentralized clinical trials to patient recruitment to COVID-19, but every session is specific to rare disease. There will be a heavy session load from sponsors, though, with nearly every other session time taken up by sponsor sessions.

Event: Clinical Trial Impact Summit

Dates: Sept. 14-16 
Location: Virtual
Cost: $595

Relevant topics: Decentralized trials, technology improvements, patient enrollment & experience, risk-based quality management, global clinical trial data disclosure, quality-by-design, digital clinical development, trial innovation

This event looks interesting, but the website is poorly executed. It’s difficult to understand if the dates are September as advertised, or in November (noted through the registration link). If it’s really happening, it looks like you can expect a focus on technology-enabled clinical trials, like decentralized trials. However, you should probably reach out to them directly to get the real story before you register.

Event: Biotech Week Boston

Dates: Sept. 20-30 
Location: Hybrid Event! Virtual + Boston, MA, USA
Cost: Starting at $895 Early Bird Pricing

Relevant topics: Drug development, Manufacturing strategy & bioprocessing, Biopharma alliance trends, Biopharma M&A trends, AI’s potential role in the revolution of drug discovery, Machine learning

With Boston the epicenter of the life sciences industry, this event’s location is likely borne out of convenience rather than a focus on the local community’s interests. After a virtual event in 2020, the 2021 Biotech Week Boston is a hybrid event, hosted over 10 days in both the city and online. It’s sure to be comprehensive, bringing thought leaders, experts, and startups from discovery, financing, event planning, manufacturing, and clinical trials. Make sure you choose the right event for you. If you’re looking for clinical operations conferences, check out the track for BioPharm, held on 20-23 Sept.

Event: SOCRA Annual Conference

Dates: Sept. 22-25
Location: Virtual
Cost: $525 for non-members includes an annual SOCRA membership

Relevant topics: Site efficiency and effectiveness, Centralized monitoring, Remote monitoring, Regulatory and quality parameters of electronic data records, e-consent, IRB approval

Touting over 1,000+ attendees, SOCRA annual draws investigators, research coordinators, research associates, project managers, consultants, educators, and administrators from across the life sciences industry. There are some great, specific tracks servicing topics like pediatrics, oncology, and behavioral health, as well as broad topics like Site Management and Training. Plus, there are a number of pre-conference workshops available to extend your learning. 

Event: SCDM 2021 Virtual Conference

Dates: Sept. 26-29
Location: Virtual
Cost: $695 for members, $795 for non-members, and group rates available

Relevant topics: AI and machine learning, Data management, Clinical site immersion, Risk based quality monitoring, Patient safety

The Society for Clinical Data Management (SCDM) makes it clear that this is a very focused event, designed to educate and advocate for the data scientists and data managers of our industry. Since it’s virtual, and with a (relatively) low cost to attend, this could be a great upskilling opportunity for anyone interested in becoming more knowledgeable about data management, the future of AI in clinical research, or emerging data management trends.

Event: DPharm: Disruptive Innovations to Advance Clinical Trials

Dates: Sept. 28-29
Location: Hybrid event! Boston, MA & Virtual
Cost: Early bird rates start at $600 (virtual) and $1795 (in-person)

Relevant topics: Real world data, Clinical trial readiness, Patient data access and ownership, Digital biomarkers, Modernizing clinical endpoints, Protocol simulation, Big data & AI, Patient-centered trials

Pfizer and Janssen started DPHARM, and are still part of the steering committee. It’s no wonder then that the past speaker list features some of the industry’s heavy hitters; J&J, BMS, Merck, and many others have made an appearance in the past. We expect reasonable attendance from mid-to-large pharma, biotech (all sizes), CROs and sites.

October Events

Event: Global Site Solutions Summit

Dates: Oct. 1-3
Location: Hollywood, FL, USA
Cost: Members – $1298, Non-members – $1598

Relevant topics: Site to industry productivity, Process and communication, Business development, Patient recruitment, Social media, Contracts & budgets and Clinical technology

Produced by SCRS (Society for Clinical Research Sites), past attendees to the Global Site Solutions Summit give this event rave reviews. Heavily skewed to the sites, this is a great event for sponsors or CROs that need to network or engage more directly with site leaders. With a mix of debates, sessions, workshops, and focus groups, you will have a diverse set of opportunities to engage with site personnel and leadership.

Event: SCOPE Europe

Dates: Oct. 5-6
Location: Barcelona, Spain
Cost: €1599 until Aug. 27

Relevant topics: Protocol development, Feasibility and site selection, Study start-up, Clinical data innovation, Digital endpoints, Real world data, Patient engagement, Enrollment modeling, Enrollment and retention

SCOPE Europe is a smaller, newer version of the well-known and well-attended SCOPE Summit, usually held in Orlando. Expect to join clinical operations leaders & clinical research innovators from pharma, biotech and academia focusing on why trials succeed and why they fail, as well as budgeting, measurement, and outsourcing. Plus, any clinical operations conference in beautiful Barcelona is one to check out!

Event: MAGI’s Clinical Research vConference

Dates: Oct. 18-28
Location: Virtual
Cost: Pricing is a bit confusing, but seems to start at $295

Relevant topics: clinical operations, quality & risk management; site management; contracts; budgets & billing; regulatory compliance; management & professional skills

A favorite in the industry, MAGI has put together a ten day agenda, intended for attendee flexibility. About half of MAGI attendees have leadership roles like CEO, vice president, or director. About three-quarters have eight or more years of clinical research experience. With over 50 sessions, and a thorough online catalog, you will likely find some great content opportunities.

Event: Outsourcing in Clinical Trials (Pacific Northwest)

Dates: Oct. 20-21
Location: Seattle, WA
Cost: As high as $499, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the Pacific Northwest edition will be a face to face event, unlike many of the others – and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: Clinical Trials Summit

Dates: Oct. 26-27
Location: Madrid, Spain
Cost: TBD

Relevant topics: Trial management, including Patient recruitment and retention, Patient engagement, Site selection, Study start-up, Data Analytics, Integrating Data and Tech into Clinical Trials, Risk-Based Monitoring

Advertised as hosting only around 80 attendees, and with a focus on senior leadership, this event requires some vetting to allow you in. The summit places a heavy emphasis on networking and collaboration, highlighting more than 12 networking hours and an executive lunch. 

Event: Outsourcing in Clinical Trials (Nordics)

Dates: Oct. 26-27
Location: Copenhagen, Denmark
Cost: As high as £350, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the Nordics edition will be a face to face event, unlike many of the others – and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

November Events

Event: Clinical Trials Europe

Dates: Nov. 2-4
Location: Nice, France
Cost: Free for sponsors, £1799 for CROs

Relevant topics: Partnerships and outsourcing, operations, clinical trials technology, innovation

Clinical Trials Europe brings together clinical industry stakeholders to share experiences, benchmark strategies and discover new ideas. Last year this event was virtual, and focused heavily on COVID’s impact to clinical development. 

Event: Collaborating for Novel Solutions (CNS) Summit 2020

Dates: Nov. 7-10
Location: Boston, MA, USA
Cost: Starting at $2195

Relevant topics: Clinical development, Digital Biomarkers, Artificial intelligence, Digital therapeutics, Real world evidence, Decentralized clinical trials, Ecosystem Financial Viability, Neuroscience, Regulatory Issues, AR/VR/XR, Voice as an Endpoint

One of the few clinical operations conferences offering year round events as part of your registration, CNS Summit is a well-known and well-attended event. CNS usually brings 750+ clinical development leaders from small, mid-size, and big pharma, CRO’s and service companies, technology companies, and research sites. But some things have changed – the event has moved this year to Boston, instead of Boca Raton. They also now require you to “Apply” to attend in order to balance attendance. 

Event: Outsourcing in Clinical Trials (New England)

Dates: Nov. 9-10
Location: Boston, MA, USA
Cost: TBD, but likely free for clinical trial sponsors

Relevant topics: Clinical supplies, patient centricity, operational challenges

OCT returns to Boston for another one of its regional clinical trials conferences. They tout the aim of promoting successful collaboration among the clinical trials community. The agenda is forthcoming, and so are registration details.

Event: Pharmaceutical Research & Innovations in Pharma Industry

Dates: Nov. 12-13
Location: Vancouver, BC, Canada
Cost: €454 Early bird pricing

Relevant topics: Clinical study designs, clinical trials, CRO/sponsor clinical trials, outsourcing, clinical and medical case reports

This may be the broadest-reaching conference on this list that includes clinical operations topics. There are 22 different tracks, with one dedicated to clinical trials. If you’re looking for a clinical operations conference that has it all – or if you wear hats across the entire drug development lifecycle, this event could be a good fit. If not, it may be too broad to offer strong clinical content.

Event: Outsourcing in Clinical Trials (DACH)

Dates: Nov. 24-25
Location: Zurich, Switzerland
Cost: As high as £350, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the DACH edition will be a face to face event, and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: Clinical Operations in Oncology Trials Europe

Dates: Nov. 24-25
Location: Munich, Germany
Cost: As high as $299, but free for executives

Relevant topics: Data science, AI and data analytics, Oncology trial lifecycle, Digital solutions, Patient safety and compliance

Unlike many of the other events we attend, this one is not produced by an industry publication. Industry juggernauts like Novartis Oncology, Bristol-Myers Squibb, Novocure, and Janssen are on the speakers list. This event seeks to uncover how our industry is coping with changes in regulations, explore new opportunities through adaptive approaches and methods to run successful clinical trials. 

Event: Outsourcing in Clinical Trials (East Asia)

Dates: Nov. 30 – Dec. 2
Location: Seoul, South Korea
Cost: As high as £350, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

OCT Southeast Asia is a clinical trials conference that will be in-person this year. Co-located with Clinical Trial Supply East Asia, the event aims to enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the three days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

December Events

Event: Outsourcing in Clinical Trials (Southern California)

Dates: Dec. 7-8
Location: San Diego, CA
Cost: As high as $499, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the southern California edition will be a face to face event, unlike the others – and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: Outsourcing in Clinical Trials (UK & Ireland)

Dates: Dec. 8-9
Location: London, UK
Cost: As high as £1000, but free for clinical trial sponsors

Relevant topics: Clinical supplies, patient centricity, operational challenges

Yet another of OCT’s regional series of outsourcing in clinical trials events, this time in the UK. Big name attendees include GSK, Biogen and MHRA, and they’ve taken a slant towards sponsor-CRO relationships in this agenda. 

Event: 5th Virtual Clinical Trials

Dates: Dec. 15-16
Location: Virtual
Cost: £1096 Super early bird

Relevant topics: Virtual clinical trials

There is little information about the agenda online, but it appears that this is a focused virtual clinical trials conference. Emphasizing that attendees need to reimagine their entire clinical approach to accommodate clinical trials, you should expect specific tracks all about digital trials. 

Past 2021 Clinical Operations Conferences

January Events

Event: Fierce JPM Week

Dates: Jan. 11-13
Location: Virtual
Cost: Members – $199 through 31 Dec., $399 after. Non-members – $249 through 31 Dec., $474 after.

Relevant topics: J.P. Morgan Healthcare topics, leadership

Every January, the J.P. Morgan Healthcare Conference sets the tone for the year to come. This year, the meeting’s virtual, so Fierce Life Sciences is bringing you a virtual free event, too. They advertise a program that goes beyond the panel discussions they’re known for. Using CEO interviews, daily news recaps, and virtual roundtables, they plan to explore biopharma’s ongoing work to combat COVID-19.

Event: ACRP 2022

Dates: Jan. 12-14
Location: Virtual
Cost: Members – $199 through 31 Dec., $399 after. Non-members – $249 through 31 Dec., $474 after.

Relevant topics: Innovation, operational efficiencies, regulatory compliance

ACRP is taking an interesting position to their 2021 event and making it an all-access pass for year round learning. Kicking off with an event in January focused on innovation in the time of the pandemic, there will be three days of learning and vendor interactions. Further follow-on events are scheduled for May and September with specific focus areas for each. One fee for the year gives you entry to all the scheduled events including ACRP Contact Hours.

February Events

Event: Outsourcing in Clinical Trials (West Coast)

Dates: Feb. 24-25
Location: Virtual
Cost: As high as $499, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the west coast edition will enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

March Events

Event: SCOPE Summit

Dates: Mar. 2-4
Location: Virtual
Cost: $999 until Dec. 18, $1499 after that date

Relevant topics: Protocol development, Feasibility and site selection, Study start-up, Clinical data innovation, Digital endpoints, Real world data, Patient engagement, Enrollment modeling, Enrollment and retention

Cambridge Healthtech, the producer of this event, is a major thought leader in our industry and produces some of the best-attended events in life science. After moving nearly all of their events to virtual in 2020, CHI will continue that trend with SCOPE Summit 2021. Expect to join clinical operations leaders & clinical research innovators from pharma, biotech and academia focusing on why trials succeed and why they fail, as well as budgeting, measurement, and outsourcing.

Event: DIA Europe

Dates: March 15-19
Location: Virtual
Cost: Members – €1612,50 if you choose to share your contact information with vendors; €2150 if you don’t. Non-members – €773,75 if you choose to share your contact information with vendors; €2365 if you don’t.

Relevant topics: Clinical safety, Early phase clinical research, Patient engagement

Traditionally billed as the intersection of science, healthcare, and regulation, DIA Europe is a strong opportunity alongside the later DIA events. Continuing the trend of virtual events, this hallmark of the pharmaceutical industry calendar made the call to go virtual for 2021. Interestingly, they’re offering a large discount if you choose to share your contact information with vendors – 25% off of your ticket price.

Event: SOCRA FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference

Dates: March 16-18
Location: Virtual
Cost: Members – $100, Non-members – $175.

Relevant topics: FDA Clinical research requirements, confidence in clinical research, relationships between FDA and clinical trial staff

Designed to facilitate information-sharing among FDA representatives and the regulated community, this event is virtual and scheduled for three days. Expect to focus on the understanding of regulations, guidelines and practices, and to learn suggested methods to enhance your product development experience. 

SOCRA also offers additional clinical trials conferences in March, including those focused on Oncology and Pediatrics. Check them all out here.

Event: Future Trials Forum

Dates: March 18
Location: Virtual
Cost: TBD, but likely free for executives

Relevant topics: Decentralized and virtual clinical trials

This appears to be a new event hosted by the organization that puts on the myriad Outsourcing in Clinical Trials (OCT) events. They’ve billed it as the only event dedicated to bringing delegates together to share best practice and develop solutions for decentralized and virtual trials. You will do so by taking part in up to 3 interactive roundtable discussions, of 10 offered. If you’re a high ranking executive, you can likely attend this event free.

Event: Global Clinical Trials Connect 2021

Dates: March 22-23
Location: London, UK
Cost: £ 750.00 plus £ 150.00 VAT 

Relevant topics: Patient recruitment and site selection, innovative trial designs, patient centricity, pharmacovigilance, risk-based monitoring, outsourcing, clinical trial technology

The first face-to-face event appearing on the calendar for 2021, Clinical Trials Connect intends to focus on the global health and clinical trials around the world. Focused heavily on innovations across the clinical trial lifecycle, expect to gain better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments.

Event: Outsourcing in Clinical Trials (Southeast)

Dates: March 30-31
Location: Virtual
Cost: As high as $499, but could be free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the southeast edition will enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

April Events

 

May Events

Event: FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference

Dates: May 12-13
Location: San Antonio, TX
Cost: Members – $575, Non-members – $650

Relevant topics: FDA Clinical research requirements, Enhancing success through communication and financial incentives, and Assuring confidence in clinical research.

Want real face-to-face time with contacts from the FDA? Do it here. This two-day conference is intended to share information among FDA representatives and the regulated community. Expect a focus on helping you to understand regulations, guidelines and practices, as well as methods and opportunities to enhance your product development experience. This year in particular will be an interesting opportunity to engage with the FDA.

Event: Society for Clinical Trials Annual Meeting

Dates: May 16-19
Location: Virtual
Cost: TBD

Relevant topics: Clinical trial design, Recruitment, Outcomes, Trial management, Trials in crisis

Bringing together a broad swath of the community, this event aims to attract professionals from academia, the pharmaceutical and device industries, government agencies, medical groups and centers, and clinical research entities. Originally scheduled for May in Chicago (but recently moved to a virtual event), this conference features a theme focused on advancing rigorous and ethical trials in the pandemic era.

Event: Outsourcing in Clinical Trials (East coast)

Dates: May 25-26
Location: Virtual
Cost: As high as $499, but free for executives

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the east coast edition will enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

June Events

Event: Clinical Trials Digital Week

Dates: June 1-4
Location: Virtual
Cost: FREE!

Relevant topics: Operational challenges, partnerships and outsourcing, clinical trials technology, innovation

This virtual, global 4-day series of live educational webcasts and downloadable resources aims to provide the latest insights for operational challenges and responding to a pandemic. And it appears to be completely free to attend! Other topics include partnerships, outsourcing and operations, technology in clinical trials, and clinical innovation. 

Event: DIA 2020 Virtual Global Annual Meeting

Dates: June 27-July 1
Location: Virtual
Cost: Members –  $1034.25 if you choose to share your contact information with vendors;$1379 if you don’t. Non-members – $1341.75 if you choose to share your contact information with vendors; $1789 if you don’t.

Relevant topics: Clinical safety, Early phase clinical research, Patient engagement

Traditionally billed as the intersection of science, healthcare, and regulation, DIA Global usually hosts everything from patients to regulators – attendees from across the spectrum of the product life cycle. This hallmark of the pharmaceutical industry calendar is virtual again this year. Similar the earlier Europe event, DIA is offering a large discount if you choose to share your contact details with vendors.

 

TBD Events 

Event: Clinical Trial Innovation Summit

Dates: TBD
Location: TBD
Cost: TBD

Relevant topics: Protocol development, Feasibility and site selection, Study start-up, Clinical data innovation, Digital endpoints, Real world data, Patient engagement, Enrollment modeling, Enrollment and retention

Cambridge Healthtech, the producer of this event, is a major thought leader in our industry and produces some of the best-attended events in life sciences, like SCOPE and Bio-IT World. Expect to join clinical operations leaders & clinical research innovators from pharma, biotech and academia focusing on why trials succeed and why they fail, as well as budgeting, measurement, and outsourcing.

Didn’t find the perfect clinical operations conference for you?

We’ve probably missed a few, and the list of available webinars and resources is growing daily. If you’re especially missing the individual insights that meetings provide, check out our interview series, “Conversations in Clinical Trial Readiness” to get that personal touch.

Increasing Access to People of African Descent in Pharma: Interview with Peju Oshisanya

Peju Oshisanya joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss diversity and inclusion in clinical trials. An experienced clinical operations specialist and a strong advocate for data diversity, Peju shares her insight into the health sciences industry, evaluates opportunities for improvement, and illuminates the path forward.

Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.

Peju Oshisanya

Peju Oshisanya is a Director and Clinical Program Leader at BenevolentAI. With more than 20 years in the drug research industry, Peju is an expert in pharmaceutical organization. Her career has run the gamut from early roles as a clinical trial associate to extensive experience running a wide range of global clinical research programs. In her role at BenevolentAI, she pairs her biomedical science background with further perspective from the tech side.

Peju is a passionate proponent of diversity in data and inclusion in clinical trial research. She believes that problems of diversity and inclusion are fixable, and she has determined to become a champion of that change, working to raise awareness and dedicating her own career to upend the status quo.

Episode Highlights

  • Peju’s “aha” moment that drove home the magnitude of inequity in biopharma, health, and clinical trials
  • Why it’s crucial to really understand the communities that we want to include in research
  • How decision-makers’ personal perspectives influence which diseases are prioritized and which treatments are funded
  • Why representation needs to extend to the experts rather than stopping with the patient population
  • Why it’s misleading and counter-productive to frame populations using the term “minority”
  • How helping patients understand the importance of research in informing treatments can help motivate participation
  • The huge potential opportunity Africa represents for clinical trials
  • The problem of perception when it comes to African institutions’ preparedness
  • How mining past data can create a self-perpetuating cycle that prevents capable sites from becoming experienced sites
  • What we can do to help ameliorate diverse patient populations’ trust in the healthcare industry
  • How anyone, regardless of their role within a company, can take steps to influence diversity in research
  • How the pandemic has signaled hope for diversity and inclusion going forward

Resources:


Peju Oshisanya on LinkedIn
BenevolentAI
Conversations in Clinical Trial Readiness Interview Series

Successful Clinical Trial Management Now Means Accepting Complexity. Here’s How to Deal with It.

If it shocks you to hear that clinical trials are getting more complex, you haven’t been paying attention. Specifically, we’re collecting more endpoints. We’re performing more procedures. We’re increasing nearly every executional variable, like the number of countries, the number of sites, the number of visits per patient, and the volume of data.

In fact, during our recent interview with Ken Getz of Tufts Center for the Study of Drug Development, he pointed out that over the past 20 years, they’ve seen this become a consistent trend. 

But is the industry’s approach to clinical trial management making appropriate shifts? Making it through a clinical trial takes a lot of effort under normal circumstances. But today, with more data, sites, processes, and systems – it’s even more difficult. 

Complexity in clinical trials isn’t bad

There are so many factors that contribute to the growing complexity of clinical trials. For example, we’ve seen a greater focus on rare disease therapies and more companion diagnostics. More precision medicine emerges each year, especially in oncology, which requires greater trial preparation as we outlined recently in our interview with Krystyna Kowalczyk of Oncobay. These kinds of treatments require researchers to collect more biomarker and genetic information at every step, even as early as screening. 

Further, decentralized clinical trials and hybrid clinical trial protocol designs add complexities in execution as the industry adopts them at a more rapid pace.

And these complexities bring some great advantages. Some of the additional data leads to insights into new disease targets, or new applications for existing treatments. The adoption of more complex trial designs will bring clinical research to patients and communities previously inaccessible. 

So, though more complex, these shifts mean progress, and hope for patients. Is complexity inevitable? Likely, yes – and so succeeding with clinical trial management in the future will require clinical operations leaders to accept that.

But trial protocol complexity degrades performance

Despite the benefits that this progress brings, Tufts research has found some drawbacks. In fact, clinical trial protocol complexity is inversely correlated with performance across all measures. Whether duration of the trial, from start-up to first patient in, and even closeout, performance decreases as complexity increases.

The more complex the protocol, the longer that cycle times are. More complex protocols also have far worse failure rates and dropout rates. Complex designs see much higher numbers of protocol deviations. They also experience a much higher relative number of protocol amendments.

The complexity will continue, so clinical operations leaders must find ways to adapt. More effective understanding of sites’ clinical trial readiness is a critical need in order to achieve a fast and smooth clinical trial start up. And better preparation leads to faster start up and is the best way to counteract the well-documented growth of clinical trial delays. 

Effective clinical trial management in the future will require you to prioritize readiness of sites, teams, and caregivers

There was a time that leaders emphasized simplification of the clinical trial design. However, Getz acknowledged in our conversation with him that this was not the right goal. Reducing the number of procedures, or visits, or data endpoints is not realistic today.

Instead, he recommended a mitigation mindset. We have to find models of clinical trial management that promote success despite the growing complexities. This is especially true as we move into hybrid clinical trial models, where some patients will choose to participate remotely, and others in-person.

This is why we have to emphasize preparing and equipping people in a better way. Training the way we’ve always done it doesn’t fit a more complex future.

Data will be collected from new and complicated tools. It will come from various sources that have to be learned, installed, and integrated. Processes will involve patients that may be from remote regions, or caregivers that are in disparate timezones. 

We must do better for our sites, caregivers, and patients. We can do that by adopting better training methods, and by better analyzing their real understanding of the content to identify where they need more support. 

Clinical trial readiness as a benchmark

Using clinical trial readiness as the primary benchmark for selection of trial sites and team members also reduces delays, costs, and risks. An estimated 85% of clinical trials will experience delays, and site and staff readiness are major factors in delays. Clinical trial readiness is an overlooked, yet critical, way to increase the likelihood of a successful enrollment and ongoing study today.

Teams and sites that are better prepared are more likely to successfully recruit patients, provide better patient experiences, avoid protocol deviations, and meet deadlines. 

From the sponsor’s perspective, clinical trial readiness mitigates risk in the face of complexity. Assessing and striving for clinical trial readiness enables project team leaders to better anticipate how their teams will perform.

Clinical operations leaders want to improve readiness

Before COVID-19 impacts hit, most life sciences organizations felt that they were effective in identifying site readiness and addressing issues. In fact, 76% said they were effective in identifying which sites were ready to start recruiting. 

But the pause we took in 2020 likely put things into a new perspective. In our COVID-19 report, we discovered that 78% said they need to improve how they identify sites that are ready to perform. 

Want to improve clinical trial site readiness graph

 

A concept like clinical trial readiness, specifically trial site readiness, has been a disregarded but problematic reality for too long.

But understanding readiness will allow us to more efficiently spend time better preparing individuals to take part in complex clinical trials. 

What clinical trial readiness means in practice

What is clinical trial readiness? We write about this topic in great detail, but in summary: readiness is a measure of how prepared an individual, team, or site is to perform during a trial. 

Readiness can be measured in a number of ways, like:

  • Level of comfort with key study outcomes.
  • Ability to make good decisions in patient eligibility.
  • Confidence with SOPs and systems.

As the protocol, and the processes, become more complex and nuanced, those performing a clinical trial need more and better support. We must find ways to prepare them for the challenges ahead, especially new ones.

For more details, you can grab our comprehensive guide to clinical trial readiness.

Here is a very real example. In our podcast, Getz shared that Tufts has been doing more research into patient dose non-adherence. The group estimates that about half of all patients will intentionally not take at least one dose. 

How are you preparing your sites or caregivers to deal with this? You can – and should – address it directly.

  • Train site staff and caregivers on patient non-adherence.
  • Assess their ability to work with patients to prevent non-adherence, and proper intervention and follow-up.
  • Analyze who needs more support, and who is best equipped to address the issue.
  • Gather feedback and insights around how to better help sites, caregivers, and even the patients themselves to adhere to the dosage.
  • Distribute best practices from the site staff and caregivers who have proven to be ready.

Clinical trial management solutions can help you now

The clinical trial is a complex set of processes, with many steps and people involved. The more complex the protocol, as well – the more risk there is to the timeline. 

And if you don’t meet study timelines in the trial start-up, it greatly impacts the likelihood of missing other study milestones in the future. This is why it’s so important to prioritize the success of our sites and participants. Knowing who needs help – and in what area – will move everyone ahead faster.

Don’t look at growing complexity as a problem, but instead as an opportunity to drive overdue improvements. It is a reason to establish new and better processes to pave a path for running better trials. An opportunity to better support the site staff who will be caring for patients as they test your therapy. A step towards reducing your risk and error. And for embracing a future where you may run a truly decentralized clinical trial, or even a fully virtual trial. 

Technology will make this shift much easier, and it can also deliver benefits to the rest of your team if you recognize these three challenges, and plan for them. Ready by ArcheMedX can help you improve your clinical trial start up, while you improve your site and team performance (and ease their workload, too).

Successful clinical trial management as complexity grows is going to require a focus on better preparing everyone in your trial. The first thing you need is an approach, and clinical trial readiness is an ideal one. Learn more in the Definitive Guide to Clinical Trial Readiness.

As the Cost of Clinical Trials Climbs, Here Are 3 Ways to Save

By all accounts, the cost of clinical trials continues to rise. We hear reasons that include increasing protocol complexity, patient recruitment struggles, or regulatory challenges. And we shrug our shoulders. Most of us accept these rising costs and obstacles as a given.

But – why?

If you could predict the future problems and risk areas for your upcoming clinical trial, you’d make changes, wouldn’t you? 

Over the past year, we’ve been researching how much of the cost of a clinical trial is wasted. That is – money spent on unnecessary activities, or spent while waiting to get through preventable delays. Unsurprisingly for most clinical operations leaders, the largest part of wasted budget comes from those delays.

By analyzing and applying decades of clinical trial data, we produced a benchmark data powered clinical trial calculator. And we’ve been using it to model upcoming clinical trials to reveal where these budget line items could be reduced. So now, in this article, we’re going to share some of the biggest takeaways from where clinical trials are throwing money away.

The math behind the calculations around the cost of clinical trials

Before we get to the biggest cost drivers in clinical trials, let’s explore how many of these calculations are derived.

First, there are a number of widely cited and accepted industry standards. For example, our colleagues at ACRP tell us that CRA turnover at CROs is a whopping 30%

Similarly, we know that a typical turnover for clinical support staff is around 16%, from MGMA. 

These two data points alone reveal the great burden that sponsors (and CROs, and sites) have to shoulder. These are risks that are accepted, but not addressed – at least not proactively.

In addition to including data standards around turnover, we incorporated well-documented cost averages for specific activities during site startup, such as traditional PI meetings and SIV visits. We also cross-referenced multiple resources like Kunal Sampat’s ultimate guide to the cost of clinical trials

We also validated our models utilizing resources like Clinical SCORE and Science Direct to reveal standards around the average delays in clinical trials and site performance. Based on our intensive industry research and real world evidence (validated through scorecard exercises run on currently active clinical trials), we confirmed that the greatest unnecessary cost in clinical trials is the result of preventable delays.

By preventing delays, you’ll see a major clinical trial cost reduction

After analyzing mountains of clinical trial data with our scorecard, delays were a major contributor to budget waste. If we could prevent just a measly 20% of the delays, we’d see a huge reduction in the cost of clinical trials.

Complexity was a primary red flag for expanding the cost of clinical trials.

Complexity is not easy to define, because it’s a combination of so many pieces. As we discussed in our recent podcast episode with Ken Getz of Tufts CSDD, one factor is the growing amount of data collected. Other factors include the number of sites, therapy area, intensity of patient care, and lab environments. 

The more complex a trial is, the more likely the occurrence of delays. Those delays can be because:

  • Sites are slow to enroll because they’re not ready.
  • Trial sites that fail to enroll patients altogether.
  • Sites enroll ineligible subjects.
  • Data has to be tossed out because of deviations.

Case study: a fully outsourced Phase II biopharma clinical trial

We ran a scorecard for a biopharma who is fully outsourced to CROs on their Phase II study. It comprised 12 months with just 6 sites. 

After we ran their scores, we found a high risk of delays due to complexity. Some of their specific factors were:

  • Therapy area – some areas, like oncology and cell/gene therapy – are more complex by nature.
  • Protocol design – more complex, as self-selected by the biopharma.
  • Being fully outsourced to CROs.

This translated to wasting over 10% of their budget.

The total waste was $1.2 M. Most of that waste came from preventable delays from our scorecard exercise. With a trial this small, that was an eye-opening amount that could be saved. Unsurprising, the larger the trial, the more potential for delays – and the greater the savings we can find with the scorecard.

This clinical trial pre-startup scorecard finds ways to slash the cost of clinical trials. Want to try it out?

Cut the unnecessary work that fuels the growing cost of clinical trials

There is so much work that needs to be done to begin a clinical trial. Just starting up is a herculean task.

And contract research organizations know this. So while you will see huge proposals from many CROs, what you won’t see is a push to reduce the manual and mundane activities they’ve always done. 

But sponsors have control, and some CROs are pushing innovation as a value proposition. So where can you cut? 

Content creation

Months of time, and a myriad of people, go into the development of the clinical trial protocol. More still to create supporting materials, and the monitoring plan. The work has been done to perfect the content. 

So why spend more hours, and possibly weeks, to move those assets into a slide deck? 

It is – quite simply – redundant work. And even worse, this wasted effort leads to worse trial performance, not better. Why? Many times, trial teams don’t spend time to craft SIV decks well, leading to confusion around the protocol and key study documents.

There has to be a better way to initiative sites. Instead, digitize the protocol and deliver your study content directly to your sites. Tailor it to each individual’s role in the study and save all of that time generating bad slide decks. Tools like Ready make this simple for you – and engaging for them. Your clinical trial team and sites need a better way to consume and understand the protocol. Why add to their burden with more slide decks they either ignore or worse, confuse them?

The investigator meeting

Even one small in-person PI meeting can be extremely expensive. And not just in money – it’s a cause for stress on every site that has to attend. Hours away from their day-to-day role creates additional burden on them and their patients.

Plus, whether you’re planning an in-person meeting, or a virtual one, we’ll always have the possibility that some, or most, of your PIs will be unable to meet at a specific time. That likelihood grows the longer the meeting is. 

So why would you choose a live web meeting when you can make it available to attendees on-demand? 

Cut the giant budget line item, and deliver your streamlined content online, and on-demand. Save your sites and trial team the burden of attending, too. 

And more importantly, let the data that can be captured in an on-demand learning experience inform your understanding of which PIs and site personnel are actually ready to enroll patients.  Don’t waste more time by scheduling an SIV when the PI and coordinator have little to no understanding of your protocol.

The site initiation visit

Speaking of burden (especially when the site is unprepared for the visit), have you considered the impact to a site during a SIV? Is the visit a true value-add to your process, and to the site staff? Or is it just another hoop through which they must all jump?

With the virtual study startup tools available today, you should be taking a closer look at the possibility of re-imagining and overhauling this task. 

With a new mindset on how you can approach SIV, deliver content on-demand ahead of a planned live/virtual visit, you can monitor each site’s progress through your study content – and then tailor the live activities to their schedule – and their needs. Let the data, not a pre-set checklist of tasks, inform and determine how you speed up a site, or slow them down.

Tailor follow ups to just the topics they’re struggling with. Monitor individual site staff, and suggest they make changes based on people when necessary. 

Reducing the effort in all of these areas will also slash the number of unnecessary site visits and travel for your CRO’s team.

Bottom line: don’t sign a CRO proposal without getting your scorecard and finding how you can save on SIVs. There are many clinical trial costs you can quickly eliminate!

This clinical trial pre-startup scorecard can reveal major contributors to the cost of clinical trials. Want to try it out?

Don’t ignore site performance as a contributor to the cost of clinical trials 

One troubling benchmark we found revealed that as much as 86% of clinical trials do not meet recruitment targets on time. How many sites did you have to close down last trial?

Many clinical trial sponsors – and CROs – ignore site failure as “inevitable.” This is a mistake. 

Activating sites that aren’t ready or equipped to enroll will create huge amounts of wasted budget for your trial. You can – and should – take a more informed decision.

Using Ready, for example, to understand which sites are truly prepared to enroll fast and succeed in your trial, you will avoid these delays and the related budget.

Another performance risk is turnover: you can not prevent it. Site staff will transition and occasionally leave your study.

And that staff turnover means you incur the cost of training the replacements for your ongoing clinical trial. This typically occurs in person, and requires time from site staff. It also can demand hours of support and sometimes travel costs from the CRA. 

But you can plan for this, and reuse your virtual startup initiatives to prevent additional delays and costs due to that turnover. Using Ready, for example, also helps speed the onboarding process, which improves quality while efficiently generating the data necessary for proper oversight.

Case study: a fully outsourced phase III biotech clinical trial

We ran our scorecard against the Phase III clinical trial for a biotech that outsources fully to CROs. After running their scores, we could forecast that they would experience a 21% turnover in the study team during the trial. 

While this is based on typical turnover, it creates a greater risk for a biotech like this one, with a very high complexity in their protocol and therapy. That means that even average turnover creates a burden on both the trial team and the sites.

That turnover was a major contributing factor to the $2M of budget waste we found. By simply creating a plan for automating onboarding and training, they could eliminate about 10% of that waste immediately.

Doing so using a strategic approach to study startup with something like Ready for clinical trials would prevent the risks that would lead to the remaining 90% of the waste. 

Upfront planning can save you a lot of money – and accelerate your clinical trial

It’s easy to look the other way when it comes to cost savings. After all, you plan your budget expecting delays and risks.

But what if you prevented those. Where else could you spend that budget? 

More importantly, what if you could hit enrollment targets sooner, and complete your clinical trial earlier? Who would benefit? The patients who need that therapy.

Using a free calculator can compare your clinical trial details against four indicators of clinical trial performance. Try it for your next trial, so you can start up with confidence. And you’ll be well on your way to slashing the cost of clinical trials you have planned.

A Decentralized Clinical Trial Requires Training at Scale. Here’s What That Means.

The decentralized clinical trial is one of the most talked-about emerging trends in the life sciences industry. These sorts of clinical trials present immense benefits, as we wrote about in a recent blog.

If executed well, the decentralized clinical trial design could both reduce resource consumption and accelerate treatments arrival to the patients that need them.

But to realize the benefits of a decentralized trial, it’s important to understand that decentralization means education at scale. It means training at scale. Because obstacles like patient treatment adherence, consistency of performance, and data collection loom large, it means you have to find a way to educate and train, assess, and then probably re-train in a way that doesn’t stretch your resources.

And it’s realistic today – if you can implement a few key changes. 

Decentralization means a focus on results, Not just training.

In the traditional clinical trial design, you have the ability to look at very discrete activities that can be tracked and completed. Each investigator or site can become a milestone on the big-picture plan.

But in a decentralized clinical trial, you lose some of the core group dynamics that come from the reliance on centralized study locations. You could be working with people in faraway regions who are much less experienced than you in clinical research. Or you may encounter healthcare practitioners with only a single patient. Or – you may be engaging with mobile nursing or care teams.

Traditional clinical trial site training was created for a scenario where people are face to face with an instructor, and perhaps have one another to lean on afterwards.

As we decentralize clinical operations, we have to shift away from the idea of “completing the training task” and shift into the concept of “driving results.”

And in case “results” feels too obtuse, let’s get specific. Start thinking about how you equip your trial team to:

  • Meet your overall enrollment targets. Where a centralized clinical trial site may have had specific site targets, a decentralized trial design doesn’t mean that.
  • Avoid deviations. Decentralization opens the opportunity to participate in a clinical trial to many more patients (and their caregivers) who may not have a lot of exposure to the process.
  • Deliver the data and results effectively. There are going to be questions, and lots of retraining. If you accept that, and plan to make and maintain clinical trial readiness as a goal for your trial team members, you will reduce the effort on your part – and on caregivers’ parts.

 

A decentralized clinical trial demands quality control. Don’t make that more work – it should be less. 

Excited to spend days turning your protocol document into a 200 site initiation presentation? No?

Good, because that’s wasted time. When thinking about a decentralized clinical trial, you need to ensure quality and consistency. Your goal should be to see how much you can reuse to reduce your workload.

There is no good reason to convert everything to a slide deck, when learning platforms like Ready by ArcheMedX make more effective training directly on the protocol possible.

Focus on the content you’ve already gotten approved. Then spend a fraction of that time you were planning to invest in converting that slide deck into a far more useful exercise. Instead, use a platform like Ready to create learning moments and resources that focus each learner’s attention on the key points that need emphasis.

You’ve saved dozens of hours on slide creation, so use it to build content that emphasizes critical protocol points.

Protocols are rarely optimized for use by trial site staff, doctors, or personnel. This can become even more critical in a decentralized clinical trial. So think critically about where a set of new eyes might miss a point. 

Where could a caregiver need more detail or more scientific background? At what points could you add some additional materials to better support the protocol? Where are trial staff making notes, asking questions, or providing key pieces of implementation feedback?

Some things we’ve seen work well in other clinical trials:

Videos presented by research or development team.

Video is also extremely powerful for keeping someone engaged. Today, you can quickly produce a video using a variety of tools. For example,  your medical director could record a 90 second talk using their iPhone on the importance of the study. Or use a personal Zoom meeting to combine a site training powerpoint, with voiceover, or even music to break up the viewing experience. 

Infographics and visual ways to present past phase results.

Charts, graphs, flowcharts, and simple images are all effective to engage people visually with concepts you’ve included already in written copy, and they can all be created by anyone with a computer and the Internet. 

The great thing about engaging people is that they’re more likely to retain the information you’re putting in front of them. A video or well-designed image will engrain a point into the staff member’s memory. 

Embedded quizzes or prompts to nudge participants at key points in the protocol.

It’s a common best practice to use real world scenarios or vignettes to drive critical thinking during learning activities. This also helps break up the learning experience.

If you’ve delivered a case study in a large group at an investigator meeting, you can easily transition that to digital exercise. Virtually, individuals must complete the activity, rather than sit as you walk through the entire story with limited interaction. Completing the activity themselves helps to attach meaning to the content you’ve provided them. That meaning is what prompts the recall of the concept in the field.

Make your vignettes complex, and make them as realistic as possible. And make them take a decision while thinking critically. Remember that you are equipping people that will have to deal with real patients and real risks during a clinical trial, and they may be without experienced clinical staff that would exist in a larger study center.

Distributed clinical teams need ongoing training and support. Plan for that.

We’ve mentioned the Forgetting Curve in previous posts. It’s well-documented that humans will forget 70% of what they learned in 24 hours. We retain information better when it’s repeated.

So it’s important to build a cadence of communication to re-emphasize points that need to be retained or remembered. But a cadence like this can help you in other ways.

There’s a trend of CRAs or trial managers sending out “newsletters” hoping to deliver best practices or updates. These can quickly become noise – and worse, vary in quality and accuracy.

In a decentralized clinical trial, there are many more people to remind, engage, and update. Establish a schedule, and centralize the execution for your dispersed personnel.

Our clients tell us that they use Ready to develop regular, ongoing communication streams with our Boosts feature. During a trial, these clients use the automated Boosts to deliver best practices that they discover from caregivers, updates to processes, and even amendments to the protocol. 

Embrace technologies that support asynchronous delivery and decentralized teams.

In losing the centralized study training models, you also avoid the struggles of coordinating calendars and travel with very busy people. Embrace the flexibility of asynchronous learning, that is – delivering your clinical trial content on-demand.

Decentralized teams may span geographies and time zones, and you could easily spend days or weeks trying to deliver various sessions to accommodate all. Instead, choose technology that lets you deploy once, and update centrally.

Asynchronous learning isn’t the same as a recorded video, that can fail to engage or deliver any measurable results. In fact, the opposite can be true.

We blog frequently about clinical trial readiness, and a large part of readiness is the ability to measure. That is, understanding how capable and confident personnel are with applying your content.

As we described previously, metrics are both available and important for clinical trial readiness, especially in a remote clinical trial.

For example, imagine your entire clinical trial team completes an online presentation covering your upcoming trial protocol. Do you present them with a quiz to test their recall of critical information?

If you do, some of the team might answer correctly because they have gained the knowledge and are ready to apply what they have learned in your trial. Others, however, may get through the test by guessing. Perhaps they all pass. 

If they do, are they all equally prepared to conduct your study or are you releasing under-prepared staff, patients, and caregivers into the field alongside others who are ready to make good decisions. Without measuring readiness, which is what we drive towards with Ready, you won’t know how risky this is until you run into trial delays and deviations, or worse. 

Ready by ArcheMedX makes decentralized clinical trial training scalable. 

There are still a lot of challenges for life science companies that want to deliver a decentralized clinical trial. Fortunately, there are some strategies that will deliver benefits to any clinical trial – and developing a scalable approach to educating clinical trial teams is one major opportunity.

The first thing you need is an approach, and clinical trial readiness is an ideal one. Learn more in the Definitive Guide to Clinical Trial Readiness.

Second, you need an on-demand delivery platform for learning at scale, and Ready by ArcheMedX is the only learning and insights platform designed to better equip clinical trial teams. Ready is an ideal tool as you work to adopt the decentralized clinical trial design, and you can get a demo today.

 

 

 

5 Challenges in Working with CROs – and How to Overcome Them

You have a clinical trial starting soon. Are you working with a contract research organization, or at least planning to do so? Probably. In 2020, the ACRP estimated that 70% of clinical trials would involve sponsors working with CROs. And, as a result, 100% of those sponsors will encounter some mix of problems.

Sponsors outsource for many reasons – to reduce costs and IRB cycle times, to improve efficiency by working with CROs who seem to have well-honed processes, or to increase the likelihood of regulatory packet approval. Working with CROs – without doubt – can be an excellent way to manage your clinical study.

But there are always challenges, and they can be expensive, frustrating, and risky. Fortunately, most CRO related issues can also be prevented.

We’ll explore 5 of the most painful – and most common – problems in this article. Plus, we’ll highlight actionable steps to overcome them. They include:

  • Losing control of the clinical trial project timeline
  • High turnover at the CRO
  • General vs. therapeutic expertise in CRAs and project team
  • Competition for CRO resource time
  • Lack of transparency

Losing control of the clinical trial project timeline

What is the largest contributor to clinical trial cost creep? Hands down, it’s delays. And most delays are preventable.

Many sponsors report that their CROs don’t (and possibly can’t) take into consideration all the risks and realities of the study during scoping. Therefore, delays are inevitable – and as timelines stretch, costs increase.

You may hope your CRO will “make up the time somewhere else” but that’s unrealistic in most cases. Plus, it typically involves additional resources and unplanned additional expenses.

Prevent problems when you’re working with CROs by:

Understanding where your risks lie – as early as possible. Detail in your project plan is key. Look at each task and break them into smaller subtasks to identify possible risk areas.

However, it is entirely possible that your greatest risks will be human. This is why using the clinical trial readiness model to improve trial performance is so impactful. Also, using a learning and predictive analytics platform, like Ready, is a great way to assess how capable your clinical trial resources actually are. 

When you are running a traditional study and need to evaluate the CRO’s team, your own trial team members, and your sites, you can reduce onsite remediation time and CRA hours drastically with clinical trial readiness. And in decentralized trials with patients, caregivers, and home health staff now responsible for conducting trial activities, using a digital tool like Ready is even more important to reveal exactly where your human capital could struggle. 

Taking a more proactive step before your first patient is enrolled will slash the likelihood of delays and keep your CRO resources on track for success. 

High turnover at the CRO

Managing CRO resources is hard enough, but the longer the project, the more that risk of turnover creeps in. In fact, ACRP quoted a recent study showing CRA turnover to be higher than 21% despite the pandemic. 

With every staff member loss, you can expect delays. Delays due to fewer available resources, delays due to higher workload, and delays due to onboarding a replacement.  Delays cost money, and they impact timelines and performance.

Prevent problems related to CRO turnover by:

Preparing for turnover. You can’t stop CRAs, PMs, and other team members from leaving, though you can select CROs with higher employee retention and negotiate key employee provisions in your CRO contract. However, turnover is inevitable – even at the best run organizations and with the most iron clad contracts. So it’s better to prepare yourself for it.

Sponsors using Ready when working with CROs follow a few best practices to safeguard against turnover-delays. These include:

  • Requiring all CRO team members to complete the same project training, regardless of when they join the trial.
  • Defining how you’ll approve the addition of new/replacement team members – an example being that replacements must demonstrate that they are sufficiently ready for conducting the trial.
  • Outlining who incurs the cost of delays related to turnover in the contract.

General vs. therapeutic expertise in CRAs and project team

When you have the luxury of in-house clinical trial resources, you tap into staff who have a deeper understanding of your therapies and the journey to get them to trial. But that’s not always how CROs staff your project.

Some CROs work hard to place resources that have specific skills or experience on each project, but not all do. Plus, many CRO resources have gained much of their experience on-the-job. Some CRAs you work with may have broad expertise, but lack therapeutic area depth. 

For some research, that’s no problem. But in more complex studies it could drag out study startup. The CRO staff could struggle to consume your materials. You could experience lower-quality deliverables. Or worse, encounter more errors during the study due to lack of preparation or critical thinking skills. 

Prevent problems when you’re working with CROs and their teams by:

Defining exactly what knowledge your CRO team needs to work successfully on your clinical trial. Your CRO will put forward resources for your project. The CRO believes they’re good enough, but it’s up to you to assess whether that team is up to your standards.

Some sponsors turn to a functional assessment of the trial team. This could be therapy-related, or include SOPs and skills gap analysis. Whatever you do to evaluate and better equip the team when working with a CRO can pay off big, especially if you use a proven platform like Ready to deliver the assessment and remediation. We found, for example, that clinicians who went through training using Ready were 2X more likely to use what they learned in the field.

A functional assessment can also do double work for you. Use your protocol and other trial materials and get some initial feedback before you provide them to your trial sites.

Competition for CRO resource time

When you’re working with a CRO, it’s important to remember that your team has other clients. The CRO resources you work with may have other projects and other responsibilities. But this leads to a common perception: the CRO is not putting enough time into the clinical trial.

Especially during the very early stages of your project, it’s difficult to get a true understanding of what the trial team is working on if you’re not communicating with them daily. And depending on your size – communication may be limited, too. Add to the mix CRA turnover, any reductions in the scope you initially wanted, and the natural disconnect between the bid and project teams, and you’ve got a recipe for delays and distrust.

Prevent problems when you’re working with CROs by:

Establishing simple ways to keep tabs on status. Whether it’s how far they’ve gotten through consuming your project’s protocol, or the status on site activation, your CRO works for you. Make it easy for them by demanding – upfront – that they commit to doing everything possible to remain transparent.

Often they have their own “reporting cadence” but that’s likely a vestigial process that is ripe for technological disruption. Have your own tools you like for project management? Get them onboarded. Need better visibility into things like CRA onboarding and investigator selection? Push them to include a tool like Ready in their processes

Lack of transparency 

And while we’re on the topic of communication, ask yourself: how much time are you (and your CRO) losing just because you’re using disparate tools? How much trust is lost between partners because of a failure to communicate?

When sponsors outsource research to CROs, they’re transferring the responsibility of running a lot of the day-to-day operations. But, as I explained earlier, they’re still responsible for the outcome. Without clear and transparent communication at every step, sponsors can become a bit, well, concerned.

Plus, CROs that use information systems and don’t provide access to the sponsor create trust issues. And worse, when a system is used but not regularly updated, trust declines.

You don’t have to struggle with these risks. Communication – and transparency – can be simplified in our current environment.

Prevent problems when working with CROs by:

Pushing your CRO to adopt technology and platforms that benefit you both. Whether it’s EDC, eCOA, or a clinical trial readiness tool, you will benefit. And the CRO will too – by developing skills and ways to accelerate your timelines (as well as other clients in the future).

One study we recently worked on involved a biotech and a CRO that had been manually creating slides based on essential study documents. When the CRO team discovered they could upload the actual protocol into Ready and create a more interactive learning experience without all the wasted time and effort, they were shocked at how much faster they could release the startup materials and measure how prepared the sites actually were.

This is just one example of where a sponsor was able to push a CRO to change, to mutual benefit. Reduce your own timelines, and know you’re helping the next trial, too.

CROs are only as good as you equip them to be.

Whatever the reason you have for outsourcing your research to your CRO partners, you’re making a major investment by trusting these companies with your therapy.

Even the smallest biotech companies have the power to impact the CRO’s performance. Be proactive by preparing the project teams, and demand transparency throughout your project. Technology like Ready makes it easy to do this today, and adopting processes and tools that support clinical trial readiness will ensure that working with CROs becomes one of the best parts of any research project.

How Can We Manage the Increasing Complexity of Clinical Trial Protocols?: Interview with Ken Getz of Tufts Center for the Study of Drug Development

Ken Getz joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss the growing complexity in clinical trial protocols. The Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine, Ken shares his insights on protocol design along with strategic advice on how to design for maximum impact.

Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.

Ken Getz

Ken Getz is the Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. Ken is an expert in drug development management and practices who has dedicated much of his career to raising awareness of clinical research enterprise.

In addition to frequently speaking at industry events and publishing in peer-reviewed journals, Ken is the founder of several organizations, including the non-profit CISCRP and the publisher CenterWatch. His career is a true testament to his belief in the importance of transparency and keeping all clinical research stakeholders well-informed.

Episode Highlights

  • The takeaways, both expected and surprising, from 2020 protocol performance data
  • The factors that are contributing to increased complexity in clinical trial protocols
  • Why simplifying the design of a study is not the right goal
  • The inherent benefits in complexity, and how we can reap them through proper management
  • What drives regulatory agencies to seek to quell rising complexity in clinical trial protocols
  • Why more data isn’t necessarily better
  • The importance of investigating underlying causes of problems rather than defaulting to solving them with volume
  • What happened to feasibility committees and what should replace them
  • Why it’s critical to incorporate patient input into study design
  • The consistent positive impact of patient advisory boards
  • How taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later on

Resources:

Tufts Center for the Study of Drug Development
Ken Getz on LinkedIn
CISCRP
CenterWatch
Conversations in Clinical Trial Readiness Interview Series

ValenzaBio Selects Ready by ArcheMedX to Expedite Biomarker Study

CHARLOTTESVILLE, VA Apr. 21, 2021 — ArcheMedX announced today that ValenzaBio, a biotech focused on developing monoclonal antibody therapeutics for autoimmune and inflammatory indications, has selected Ready, the industry’s leading clinical trial learning and predictive analytics platform, to optimize performance on its upcoming Phase II study.

ValenzaBio is deploying Ready to transform the critical phases of study start-up and on-going site engagement for their VB119 study. With Ready, ValenzaBio will avoid the typical delays that impede 85% of all clinical trials by implementing an on-demand, clinical trial readiness solution to increase the preparedness of its trial team and study sites.

“The ValenzaBio team is aggressively moving our research forward for monoclonal antibodies. To continue this pace during these uncertain times, we knew we wanted a more innovative and future-proof approach to the next phase studies,” said Jay Mitchell, VP, Clinical Operations at ValenzaBio. “We selected the Ready platform because we could see the immediate and long-term benefits in performance and efficiency, cost reduction, and improved oversight into our CRO relationship.”

Ready by ArcheMedX enables life sciences organizations to better equip and evaluate trial teams and sites, revealing those most prepared to start and effectively conduct the study. By transforming study documents into interactive learning experiences, Ready helps to eliminate manual tasks as it virtualizes start-up activities and automates upskilling over time. The predictive insights Ready provides allows CROs and trial sponsors to prioritize site activation, accelerate enrollment, and avoid preventable delays throughout the study.

“We are thrilled to add ValenzaBio to our growing list of forward-thinking pharma, biotech, medical device, and CRO clients,” said Joel Selzer, CEO of ArcheMedX. “Trial sponsors and CROs must confront the dual challenge of competing in an already difficult market and overcoming operational barriers still posed by the pandemic. We enable our clients to adapt and innovate, and ValenzaBio is already leaping ahead.”

Want to learn more about Ready? Click here to request a demo.

As ValenzaBio deploys Ready, the biotech will:

  • Eliminate most or all of the traditional travel- and hosting-related costs associated with primary investigator meetings and site initiation visits.
  • Significantly reduce costs related to turnover, initiating sites or CRO resources that are not ready, and performance-related delays.
  • Gain visibility to both CRO and site staff preparedness, areas of risk, and content deficiency.
  • Reduce site burden by enabling an on-demand asynchronous solution to deliver  investigator training and preparing site members. 
  • Improve site engagement by increasing retention of study knowledge, and improving understanding of study changes.
  • Better inform operational decisions through predictive insights.

About ArcheMedX:

ArcheMedX helps companies across the life sciences and healthcare industries to better equip, evaluate, and predict team and clinician performance, in order to accelerate the development and adoption of new clinical treatments and best practices.

Ready by ArcheMedX is an industry leading solution that predicts and improves clinical trial performance. The platform applies behavioral science to enhance how trial team members and site personnel will apply knowledge and skills in real-world scenarios. Ready then analyzes unique behavioral indicators to reveal areas of trial readiness and potential risk. 

To learn more about our readiness solutions across clinical operations, commercial programs, and medical education, visit www.archemedx.com or follow ArcheMedX on LinkedIn.

About ValenzaBio:

ValenzaBio is a privately held biopharmaceutical company focused on developing safe and effective therapies for autoimmune and inflammatory diseases. The company is advancing a pipeline of differentiated monoclonal antibodies targeting clinically validated mechanisms of action, in order to provide improved therapies for patients with limited treatment options. ValenzaBio’s lead program, VB119, is being developed for the treatment of membranous nephropathy (MN), followed by VB421, which is being developed for the treatment of thyroid eye disease. ValenzaBio is based in Bethesda, Md. For more information, please visit www.valenzabiotech.com.

Request a demo of Ready

 

Continue Reading

An Honest Look at How Demanding Oncology Trials Have Become: Interview with Rebecca Setta of Oncosec

Rebecca Setta joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss effective management of sites and teams through arduous clinical trials.

Rebecca shares how she’s kept her team motivated and productive in spite of the added burdens imposed by the pandemic, and why she’s excited about the future of the industry.

Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.

Rebecca Setta

Rebecca Setta is an Associate Director at OncoSec whose 13 years of experience in clinical trials have given her the benefit of several different perspectives. Rebecca began her career on the vendor side, and her continuous pursuit of development and higher-level understanding led her to transition to the CRO space in 2015. Her role at OncoSec represents the natural evolution of a career shaped around an inherent desire for growth through further immersion in clinical trials.

In Rebecca’s years of experience at the project level, she consistently found building effective teams to be among the most rewarding elements of her work. She now brings that expertise to bear at the department level, where she can act as a mentor, shaping a team to build on her knowledge and experience.

Episode Highlights

  • How Rebecca helps her team avoid burnout in a grueling field
  • The common characteristics she saw across the sites that adapted best at the start of the pandemic
  • A crucial change in mindset that she’s encouraged in her CRAs
  • The COVID-inflicted adaptations she expects to persist post-pandemic
  • Why it’s important to partner with sites
  • The unexpected upside to the pandemic adjustments her sites have made
  • What really impresses her about the industry
  • How remote work and limited face time can impact morale, and one way she compensates for that
  • How the weighty context of oncology research can also translate to motivation
  • Why she is so excited about the future of the industry

Resources:

Oncosec
Find Oncosec on LinkedIn
Find Oncosec on Twitter
Conversations in Clinical Trial Readiness Interview Series

Got a Clinical Trial Startup Post-COVID? Plan to Tackle 3 Big Challenges

There are still a lot of challenges facing pharmaceuticals, med tech, and biotech companies that seek to begin a clinical trial post-COVID. But the obstacles aren’t stopping them. At time of writing, over 500 companies have a Phase II or Phase III clinical trial startup planned in the next 12 months. Clinical research moves on, as it must.

If you’re planning a clinical trial, you already recognize some major differences from past studies. And the emergence of new trial designs like decentralized clinical trials and hybrid trials provide new opportunities – and obstacles of their own. 

However, regardless of your clinical trial design, there are three major differences every clinical operations leader needs to expect. Here’s a discussion of each one – along with some ideas of how to tackle them.

First, remember that it’s anything but “business as usual” for your clinical trial sites.

You feel the challenges of the ongoing pandemic, don’t you? Remember that many of the site staff are frontline healthcare workers. Their challenging day jobs are exacerbated by everything you’re feeling.

And you may worry about loading up already stretched site staff. There’s a lot they have to do before they even enroll the first patient: study startup training, initiation, and activation activities.

But with the availability of new digital and remote enabled tools, you can actually use the clinical trial startup to reduce site burden.

 

Reduce site burden by accommodating their busy schedules.

No, I don’t mean running web meetings every hour on the hour. Instead, think asynchronously. That is – make your protocol and clinical trial content available on-demand, instead of on your schedule.

On-demand start-up activities, such as site training, ease the load of the all-day meeting for site staff.  It also accelerates enrollment, because staff can begin preparing to screen patients as soon as your on-demand training is available. No more waiting for schedules to align for a group meeting or visit.

Using more advanced tools (like Ready) to deliver interactive training also enables you to collect valuable data immediately.  This data can then inform faster operational decisions (i.e., prioritizing site activation and monitoring coverage) based on real-time insights into site and staff readiness.  One of our largest clients, PRA Health Sciences values this quick access to data and actionable insights.

In fact, in equipping their own CRAs, PRA’s leadership uses Ready to deploy more interactive content globally. They can quickly determine which of their CRA team members are ready for a specific trial, and which ones need more preparation. This lets them intervene early to increase the capabilities of their teams where needed. You can do the same with site staff, or even your CRO’s team members.

Reduce site burden by consolidating their clinical study startup resources in a single hub, available anytime.

When you provide site training and activities in an on-demand environment, you get to avoid sending multiple files, portals, or emails stuffed with attachments. 

Centralize your study startup content into a single portal, or learning experience. And cut the extraneous noise of extra emails.

Tools like Ready make it so easy for you to build your site training around your existing protocol and essential study documents. Instead of wasting time converting each document into a slide deck, and then trying to deliver individual training sessions for each site, a far more useful exercise is to utilize a platform like Ready to turn that essential document into an on-demand and highly engaging learning experience.

Best of all you can do this in hours, not days and weeks. This saves valuable time (and possibly many hours of billable CRO time), and helps to drive consistency in your content. As we suggested in a recent article, you can re-invest some of the saved time by pulling together complementary resources, or improving your assessments.

And packaging all of your resources into a focused learning experience makes it easy for you to update, enhance, and deploy the same quality of learning to everyone even if they join a site part-way through a trial. Even better, it simplifies the lives of your site staff. It helps them to know where to go for everything related to your protocol, SOPs, and best practices.

Second, the reasons you had for using the same sites for every study startup are not as compelling now.

There’s really no good reason to only stick with “tried and true” sites post-pandemic. In a recent interview with Liz Beatty, the Chief Strategy Officer of Inato, she revealed that 70% of clinical trials are performed by the same 5% of trial sites.

And is there a great reason for that? Despite the belief that tried and true sites should be reliable to enroll and perform, there has been no marked improvement in the performance of clinical trial sites over recent history. In fact, Tufts reported that the clinical period has gotten longer.

It’s an ideal time to disrupt your model for activating sites for two major reasons.

Getting onsite is difficult today, so location isn’t as critical.

While it’s difficult to get onsite today, it is, and has always been, a burden to your sites when you’re there. In the push to reduce site burden, now is the time to reduce your reliance on in-person visits. Without that barrier, your site options expand greatly.

Is it now possible for you to consider sites that may be in regions that offer more diversity? Or perhaps areas with a less experienced but highly motivated investigator who has an available patient population…but hasn’t worked with you before?

The opportunity to expand to new sites and untapped patient populations has never been greater. Plus, over the past two years it has become evident that not only is diversity in your patient demographics needed, but it will be expected. Investors, partners, regulators, and the entire industry are expecting clinical trial leaders to learn and to change how they research treatments across ethnicities, cultures, lifestyles, and ages.

There are ways for you to objectively measure site readiness early in the clinical trial startup.

A site’s experience with you, your CRO, or any past clinical trial doesn’t tell the full story about its ability to perform in your upcoming trial. Site staff change, patient populations shift, sites may be enrolling competing studies. Solutions like Ready can reveal the critical insights you need to know about a site and its staff capabilities as they currently exist.

  • Want to see their confidence in enrolling the right patients quickly? Easily done.
  • Need to understand staff knowledge around handling and administering your investigational product? A snap.
  • Think it’s important to assess a site’s understanding of decision-making on exclusion criteria? Yep, that’s easy, too.

With objective and immediate readiness analysis available across all sites, both new and old, there is no need to guess about which sites can perform. You can have the same level of confidence whether you’ve worked with a site a dozen times, or never before. And – likely slash the risk of missing enrollment targets.

 

Third, the big in-person investigator meeting is not only off the table, it may be gone for good. 

OK, it’s probably not gone for every clinical trial for good. But depending on your specific objectives, you may not need it. And if that’s the case, you’ll greatly reduce your costs and workload. Plus, you’ll avoid the burden of scheduling a lot of very busy people away for hours or even days more than necessary.

One emerging biotech we work with has reimagined the PI meeting completely. This biotech instead chose to use Ready to deploy all of their PI meeting content completely online and completely on-demand. That means, similar to site training, investigators and study coordinators can begin consuming the protocol as soon as it’s deployed by the biotech. And that means the trial team can immediately discover insights about investigator readiness, too.

Just as you adjust your clinical trial startup, your trial team will adjust, too.

Fortunately, we humans are natural innovators, and natural adapters. You’ve already had to make major changes, and your sites, teams, and patients are making changes too, too. 

But when you’re not there in-person with your clinical trial resources, it’s easy to lose sight of the opportunities you have to help them adjust to your changes. 

Take the ongoing uncertainty in our environment as an opportunity to change. Don’t just do it for your next trial, but establish new and better processes to pave a path for running higher performing trials. For reducing your risk and error. And for embracing a future where you may run a truly decentralized clinical trial, or even a fully virtual trial. 

New digital tools and predictive models will make this shift much easier, and can also deliver benefits to the rest of your team. But you must recognize these three challenges, and plan for them. Ready by ArcheMedX can help you improve your clinical trial startup, while you simultaneously improve your site and team performance (and ease their workload, too).