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PRA Health Sciences to Present with ArcheMedX at Clinical Trial Innovations Summit 2020

ArcheMedX today announced its on-going collaboration with PRA Health Sciences in a highly anticipated joint case study at the 2020 Clinical Trial Innovations Summit.

On Wednesday, 11 November, Kelly Ritch, EVP of Product and Clinical Solutions at ArcheMedX, will join Susan Zakarian, Sr. Manager of PRA Health Sciences to co-present a session titled:  How PRA Health Sciences Virtualized Clinical Operations Performance Management.

This session will explore how PRA Health Sciences continues to transform performance management across clinical operations by embracing a virtualized approach that identifies leading indicators of readiness to predict and improve performance in the field. PRA Health Sciences chose to partner with ArcheMedX in order to: 

  • Better understand team members’ actual capabilities and potential to grow in their role
  • Help managers more accurately identify and focus on team members’ areas of demonstrated need 
  • Reduce workload by replacing time consuming evaluations with a standardized, data-enabled solution
  • Streamline and automate individual remediation and upskilling

In the discussion, Ms. Ritch and Ms. Zakarian will reveal how PRA built the business case for this undertaking, the process they used, and the outcomes they’ve realized from the on-going success.

The Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) and Clinical Trial Innovation Summit have become a combined two-day event serving clinical innovation leaders, clinical operations executives, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World.

The event features 8 keynote presentation and panel sessions, five conference tracks, interactive breakout discussion groups, and networking.

[Updated] You can now access the final presentation on-demand:

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Women of Color in Pharma Launches “Ally is a Verb” Learning Activity with ArcheMedX

Women of Color in Pharma (WOCIP) has emerged as a leading organization teaching our industry how to empower women of color through bold action.

Their value to all of us is best explained in their “Our Why” statement, where they commit to “Creating a nurturing and safe environment for self-reflection and discovery amongst Black and Latina women to foster personal and professional growth that will address a critical gap required to promote innovation and leadership.”

Through many initiatives, not least of which is their annual conference, WOCIP has been a leading voice to promote the professional growth and development of female leaders of color in the pharmaceutical industry.

And now, ArcheMedX is honored to announce our partnership with WOCIP. We commit to amplifying their voice and their mission, through both support as a member, and as an active ally.

And as an ally, we want to highlight WOCIP’s first learning activity powered by ArcheMedX on the Ready platform, “Ally is a Verb.”

This learning activity, anchored by WOCIP’s recent panel discussion, is infused with valuable resources and tools and serves to illuminate the experiences and perspectives of Black and Latina professionals. This learning experience also exposes the responsibilities and opportunities that white and male allies have to elevate and support women of color in their professional journeys.

When ArcheMedX committed to take action to uplift and amplify Black and POC voices in recent weeks, we sought out new partners and specific opportunities. This partnership is just one way that we seek to take positive action where we have influence.

“WOCIP has been instrumental in the growth of so many admirable leaders in the pharma industry, and we are committed to amplifying their voice and the need for allyship. The time for dramatic societal change is long overdue, and the entire ArcheMedX team is aligned in this mission and honored to play a more active role. ”

We will continue to seek additional ways to support the Black community, and we urge others to do the same.

As we stated before, there is no excuse for discrimination and mistreatment of anyone, especially because of their race, gender, sexual orientation, disability or any other characteristic.  We must ALL commit to taking action and that begins in our own small corner of the world.

The Virtual Clinical Trial Start-Up: How to Make It Work

Making it through the clinical trial start-up process is critical for any study – and takes a lot of effort under normal circumstances. But today, with the need to conduct more and more clinical operations remotely – it’s even more challenging. 

The good news is that there is a way forward, because as our recent survey and report revealed, study start-up is a priority for virtualization.

Since we can’t rely on the procedures we’ve used for years, how do we resume or start-up a trial in this new virtual world with new untested processes? How do we do it right? Let’s take a look at some actionable steps.

Deliver the Investigator Meeting with Virtual Meeting Technology

Our recent report revealed the PI meeting is a major target for a digital enablement. Prior to COVID-19, only 33% of the respondents to the survey felt PI meetings could be conducted virtually. But now – 65% of Sponsors believe that a virtual meeting can be just as — or even more — effective as a face-to-face one.

If you’re preparing to make this a capability in your organization, don’t make the mistake of thinking you can just repurpose your standard PI meeting content and deliver it via a web meeting tool. To really succeed with a virtual meeting, you will need to transform the agenda and design a different overall experience.

65% of Sponsors believe that a virtual meeting can be just as — or even more — effective as a face-to-face one.

If you’re preparing to make this a capability in your organization, don’t make the mistake of thinking you can just repurpose your standard PI meeting content and deliver it via a web meeting tool. To really succeed with a virtual meeting, you will need to transform the agenda and design a different overall experience. 

There are four key steps you should take to effectively virtualize the investigator meeting, all of which we describe fully in our recent blog “Running a Virtual Investigator Meeting in 4 Steps.”

To summarize, those four steps are:

  • Get your technology right. There are numerous technologies you can use to deliver a virtual meeting – from those that are specialized for clinical trials to those that just host a video. Make sure you choose the right one for your purposes. 
  • Plan and deliver a virtual-first agenda. Moving to a virtual meeting does raise the risk of losing your audience faster. Make sure you rework your content in a way that will improve attendee engagement and the outcome of your meeting.
  • Evaluate learning with analytics. A key benefit of digitizing content delivery and training is the rich data! Be sure to take advantage of the insights you can glean. For example, these data can inform site selection, site initiation, and monitoring decisions.
  • Demonstrate the effectiveness of your virtual meeting. If you’re putting in the work, take advantage of the outcomes downstream – for example, in proving you were more effective in site selection.

Inform Final Site Selection with Data from the Virtual PI Meeting

Our COVID-19 report showed half of respondents sought to use virtual methods exclusively for site selection, In fact, 70% of Pharmaceuticals respondents said they plan to replace in-person activities with virtual delivery for this important clinical trial start-up activity

This could mean great things for clinical trial start-up timelines. The average time to form a site list is around 2-3 months. The biggest benefit of virtualizing how you assess and select investigators and sites is speed. You can deliver it faster when you eliminate travel and dramatically improve decision making by gathering intelligence about the attendees and their readiness earlier. 

So how do we do this? Normal procedures involve the PI meeting as well as an on-site evaluation of the facility and staff. We can virtualize so much of that process using a virtual training platform like Ready, which offers assessment capabilities that greatly increase your likelihood of selecting the most capable sites.

Using a tool like this allows you to answer the critical questions for selecting the right sites to start-up, like:

How prepared is the site to recruit the right study patients? 

This is a critical priority in site selection, and the easiest to validate with a virtual process. For example, our clients use Ready to deliver content virtually to not only train – but also assess investigators and sites on their understanding of the protocol, eligibility criteria, familiarity with the patient population, and other indicators. This paints a truly accurate picture of whether a site can enroll. 

Does the site have qualified and sufficient personnel to conduct the study? 

Again, with a virtual model, you can more easily engage and evaluate additional site personnel beyond the PI to better assess (at scale) the capabilities of a site’s study team. Delivering training and assessment via a virtual, on-demand model allows you to be more inclusive and provides site personnel more flexibility to participate at a time and place that fits their already busy schedules.

Can the site use the electronic equipment and systems required? 

In a virtual model, you can deliver targeted training and evaluation around the use of critical electronic systems and other equipment more effectively to the right site personnel, increasing the chances for better start-up execution.

Utilize the blend of a virtual assessment with the delivery of study content to create a more informed site selection process. In the past, many trial teams had to rely on too little data or subjective information in choosing sites for a trial. 

Today, with virtual site selection methods – you don’t have to be limited. Let the data point you to the right sites who are ready to enroll and conduct the study.

Site Initiation Visits Can Go Virtual, too

Once you’ve selected your sites, we know there’s still a lot of work to do to activate them so they can start enrolling. Creating a virtual process to do this will help you in both the short-term and future studies. 

And it’s an area that the industry is focusing on: across our recent survey, 84% plan to increase their use of virtual delivery of training during site initiation. 50% overall plan to replace in-person meetings wherever possible for the SIV.

84% plan to increase their use of virtual delivery of training during site initiation. 50% overall plan to replace in-person meetings wherever possible for the SIV.

There are major tasks you can virtualize here: documentation, site staff training, and the site initiation visit itself. There are numerous tools to help you acquire necessary documentation and contract agreements from the sites, for example, which reduces time a great deal. 

But training the site staff and effectively virtualizing the meeting are areas of site activation that have remained manual for far too long. It’s a perfect use case for the deployment of remote and virtual technologies. And – if you’re planning to take your PI meetings virtual, you can and should use the same technology you adopt there for virtualizing the site initiation visit. By doing so, you can:

  • Create efficiency and scale (reduce travel, optimize staff assignments)
  • Reduce the work necessary to develop and deliver the training
  • Ensure consistency in what site staff are learning and evaluate their actual preparedness
  • Quickly identify risks in specific sites and staff ahead of the site initiative visit
  • Enable trial leaders to focus on the most critical study objectives for each site
  • Complete visits faster and with better outcomes – so that sites can begin enrolling patients sooner

In order to successfully virtualize your SIV, you need to consider the steps we wrote about recently in our blog on preparing your content for virtual training

Start with objectives for your site staff training. An example of an objective could be: “Site staff must be able to disqualify a subject that doesn’t meet criteria.” By starting with the objectives you wish to achieve, you can refocus every additional step you take to get there. 

Create your agenda with the objectives in mind. Create an outline – and tie each step in your outline back to your objectives. Protocols are rarely optimized for staff, doctor, or personnel consumption, but your training must be.

Use multimedia to encourage site staff engagement. Charts, graphs, and simple images are all effective to engage people visually with concepts.

Reduce your workload by reusing resources – and linking them in. You can encourage curiosity by adding additional, optional resources to your curriculum. It’s likely you’ve used some in creating your content already – so share what you already pulled! 

Use scenarios instead of multiple choice questions to assess decision making. You probably did case studies or an exercise in a large group at investigator meetings previously. Use the same activities for site staff to retain consistency. 

If you need to engage site staff over time, build in a follow up plan to encourage retention. Perhaps it’s a weekly email with a scenario, asking them to apply it. Or a short poll you send asking for responses each week to engage their memory.

Getting the Clinical Trial Technology Right

I’ve mentioned the technology you use a few times in this article. It’s critical that you select the right tool for your purposes. 

If you’re going to invest the time and resources in making the clinical trial start-up activities virtual, you want the resulting outcome to be a foundation for the future. And our recent study reveals that most of the industry is going this way:

  • 74% are adopting technology that supports virtual activities everywhere possible
  • 49% are converting all clinical operations meetings to virtual ones.

If you want to get the right clinical trial solution for the job, we’ve created a simple checklist that can help you.

Make the Clinical Trial Start-Up Your Priority

The trial study start-up 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 study timelines are not met 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 virtualization and efficiency of the clinical trial start-up. The ability to make many of these processes virtual will reduce preventable delays, and likely surface the risk of others so they can be avoided.

Technology has become the cornerstone for most of the workplace today, and now the clinical operations industry is moving to virtualize across the trial lifecycle. Want more information about the clinical trial start-up trends in the survey? The report is available now

Guessing could be adding 7 months of clinical trial delays. Here’s how to stop.

Getting new treatments approved has never been harder, but recent research reveals that the regulatory agency has also never been faster. So why is it getting more expensive and taking ever longer to bring a treatment to market? Three words: Clinical trial delays. 

It’s taking longer to bring a treatment to market, and clinical trial delays are partly to blame.

A recent study by Tufts Center for the Study of Drug Development revealed some shocking news: the clinical development of new drugs is lengthening, and not by days, but by months. This, despite regulatory approval time for new drugs in the United States shortening.

The actual numbers? 

Average clinical phase time increased by nearly seven months. Approval times dropped during the same time by nearly two months. In total, the time to conduct clinical studies and then complete the approval phase increased by 4.8 months.

This is a worrisome trend, worsened by our current environment fraught with delays due to COVID-19. So why is it happening?

Like any question in clinical research, the answer is complicated. However, we can point to a few truths:

  • Despite approval times reducing, regulatory agencies are keen for sponsors to include longer follow-up phases.
  • The treatments and associated trial designs continue to become more complex.
  • Delays continue to plague all phases of clinical trials.

Only the clinical trial delays are within your control as a sponsor or contract research organization (CRO). It’s well-documented that 85% of trials will experience a delay, so reducing delays is a worthy undertaking.

Let’s take a look at three places where you can – and should – stop guessing: investigator meetings, clinical trial site initiation, and clinical trial site problems.

1. Stop guessing about your investigator meetings.

When planning an investigator meeting agenda, many make assumptions about what the investigators know, and what they don’t know. We guess about what content they will find challenging and what they will find easy. And we guess about where they are going to need help. We guess…quite a bit.

Why? There are so many ways to surface what the attendees actually already understand today. We can use digital survey tools, through pre-assessments, or online knowledge analysis. 

There’s no reason to play this guessing game today and waste valuable time during the meeting. That wasted time could be spent emphasizing the critical topics that the investigators and study coordinators really need to know better. 

Better-prepared investigators and study coordinators will beget better-prepared clinical trial sites. Those sites will be better able to enroll and conduct your clinical trial, with fewer delays.

So how can we stop guessing? Some sponsors distribute a survey or ask for feedback after sharing a protocol synopsis. Others use a clinical trial solution like Ready to deliver a pre-meeting assessment or pre-meeting content. Doing so helps to understand attendees’ initial knowledge of and comfort with the planned study.

Investigator meeting content delivery will engage PIs and Study Coordinators around the content and critical questions ahead of time. This provides valuable insight to meeting planners and content developers. 

Want to go further? We recently covered how to deliver a fully virtual investigator meeting. A virtual investigator meeting will enable you to create a learning track that takes the same amount of time to develop, and much less cost to deliver. That’s because you can:

  • Prioritize content and topics based on pre-tests
  • Deliver the entire investigator meeting remotely and on-demand (reducing travel and meeting planning costs, and preventing delays at sites where the PI can not travel)
  • Prioritize follow-up content based on how the investigators and site staff perform in the training
  • Automatically send follow up content to re-emphasize critical points

Taking the guesswork out of creating your investigator meeting content, virtual or not, is a proactive step you can take to ensure that investigators and coordinators are prepared to operate at their highest level of performance. 

However, doing that alone is not going to eliminate clinical trial delays. Making your clinical trial site initiation process more accurate might.

2. Stop guessing in your clinical trial site initiation.

Many sponsors and CROs make decisions about which sites to initiate and when to initiate them using primary tools that are a bit outdated. Examples include: attendance records for investigators invited to the PI meeting, outdated historical site data, and site-provided data which could have dubious origins.

Sometimes, sites guess or inflate the number of patients that they believe they can enroll when completing the traditional site feasibility assessment. Sponsors and CROs anticipate this response and typically adjust the projections to fit their expectations for each site. 

So sites are guessing, and sponsors and CROs are responding to that with more guessing. And for an industry so focused on data endpoints and statistically relevant evidence, it’s shocking. This makes the frequency of delays in these clinical trials much more understandable. 

If you knew that removing the guesswork would reduce your clinical trial delays, wouldn’t you find a way to do so? 

More accuracy in clinical trial site initiation will reduce delays. And it is possible to achieve.

There is so much more accuracy available with digital clinical trial solutions today. As Kelly Ritch wrote previously: “We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.”

We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.

For example, combine your historical site data and performance with current, and specific, context to find the right-fit sites to initiate for any particular study. Measures can include the level of confidence and capability in this particular study’s area of focus for critical staff like the current study coordinator, the principal investigator and sub investigators. 

Or you could analyze these sites’ commitment to recruiting subjects for your study vs. their existing studies. 

You don’t have to restrict yourself to data that the site provides. Using a clinical trial solution like Ready, you could be delivering not only a remote investigator meeting, but a fully remote site analysis. Then you could determine which sites have both the historical performance and the current aptitude to succeed.

CROs and sponsors who do this deploy a remote interactive experience to prospective sites using the clinical trial protocol synopsis and key questions. As the site personnel engage with the content, the sponsors and CROs can measure their readiness and fit automatically. As a bonus, these sponsors and CROs are also gathering key inputs about the viability of the protocol first-hand.

The CROs and sponsors can quickly discover the site personnel strengths and weaknesses, their engagement levels, and how they rank vs. other potential sites.  This directly enables them to decide the order in which they should initiate sites to drive the best and highest quality enrollment.

Armed with this data, those trial teams know exactly which sites are most likely to succeed with the trial’s requirements. Even more exciting, they have new visibility into the risk areas for ill-prepared sites, and can stop guessing about site problems.

3. Stop guessing about the clinical trial site problems.

More than 1 in 3 clinical operations professionals struggle to know where and how best to help trial sites that aren’t ready to perform a trial. 

Most site problems fall into three categories:

  • Recruitment
  • Data and documentation
  • Protocol adherence

You probably have many SOPs and processes around addressing each of these. But why are you waiting to address them as they appear?

Some might suggest “additional clinical trial team training will reduce the downstream delays.” That may be true, but wouldn’t it be better, faster, and possibly cheaper to identify risk areas before you start with a clinical trial site? You may not have to push every site or staff member through additional training.

The best way to prevent clinical trial delays is to stop waiting, and be proactive. If you revert back to tip #2 – you reduce two different ways:

  • By starting your trial with sites that are less likely to experience problems
  • By identifying and remediating risk-prone sites before you start with them

Now, you can invest time and resources to upskill all or just some of those sites. Simultaneously, you can begin with limited delays from the best-equipped sites.

How does this work? 

As I described above, using a clinical trial solution like Ready, which is focused on not just training your clinical trial sites, but on predicting their performance, allows you to spot the high performing sites and those with gaps in knowledge or capability.

Better – you can uncover exactly what those gaps are. Then address them before a problem occurs.

Guess less, reduce clinical trial delays.

Sounds nice on paper, but shifting to a more data-centric approach to equipping your trial team requires thought and commitment.

We’ve created a thorough Definitive Guide to Clinical Trial Readiness, which can be a great next step for you as you focus on eliminating clinical trial delays.

Want more help? Take a demo of Ready, and see how you can be accelerating trial timelines with a comprehensive approach to clinical trial readiness.

ArcheMedX Promotes Kelly Ritch to Executive Vice President of Product and Clinical Research Solutions

Charlottesville, VA — July 14, 2020

ArcheMedX leadership is pleased to announce the promotion of Kelly Ritch to EVP of Product and Clinical Research Solutions. Ritch joined in 2019 to support the increasing demand for Ready, the company’s clinical trials platform, with sponsors and CROs. 

“Kelly has already made an indelible impact on our team in the time she’s been at ArcheMedX, and we are thrilled to elevate her into a senior leadership role. She continues to demonstrate the mindset and elite leadership skills that we require in order to scale,” said Joel Selzer, CEO and co-founder.

Ritch is known as a dynamic and innovative executive adept at driving high-performance and long-term value through the applied use of software, data, and technology driven solutions for clinical research. Her operational expertise and strategic mindset has already enabled ArcheMedX to scale the capabilities it provides to multiple clients in the clinical operations space.

“It’s been an incredible experience working closely with clinical operations leaders so far to harness the predictive power ArcheMedX provides,” said Ritch. “I’ve seen first-hand the impact that more informed decisions and improved performance can have on clinical trial efficiency and outcomes.” 

Nearly every clinical trial encounters operational challenges and according to industry reports an estimated 85% of all clinical trials will experience delays, with 94% being delayed by over a month. These delays can have significant financial costs for each day that a trial impedes a product’s development and launch. 

With her promotion, Ms. Ritch will expand her oversight across product strategy and clinical research market development, as well as contribute more to the company’s thought leadership.

Before joining the ArcheMedX team, Ms. Ritch led clinical data management, sales and marketing, clinical trial operations, and strategic partnerships for 20+ years with both sponsors and CROs.  While creating and leading high-performance teams across clinical research functions, Ritch has had the opportunity to evaluate, implement, and develop a number of key software platforms used to support and improve clinical trial performance. Ms. Ritch has earned degrees from University of Virginia, University of North Carolina Chapel Hill, and University of Virginia Darden School of Business.


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.

ArcheMedX’s flagship product, Ready, predicts and improves how teams and clinicians will apply knowledge and skills in real-world scenarios. Ready uses behavioral science to enhance how individuals learn and retain information, and delivers actionable insights enabling leaders to identify high performers, potential risks, and areas for improvement. 

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

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5 Places in Clinical Trials Where You Should Be Digital Now

Until the recent changes forced upon our industry by COVID-19, clinical research has been anything but digital: instead, relying heavily on in-person interaction, monitoring, and data collection. 

Many trials have been forced to halt, or change standard operating procedures (SOPs) in order to restart. The adoption of digital solutions has accelerated. But will these changes remain? 

With any change brought about by external forces, there is a risk that some will revert to traditional practices out of familiarity or perceived cost. But there is a huge opportunity to begin down the path of true digital transformation for your clinical teams if you stay the course. 

Here we’ll take a look at:

  • The benefits of sustained digital transformation
  • Investigator meetings
  • Site selection and site initiation
  • Site training
  • Ongoing onboarding
  • Patient data collection

What benefits will sustained digital transformation bring to clinical research?

When talking about digital transformation, most executives frame it in one of two ways: as a corporate mandate, or as a vision. Either approach, without action, rings hollow.

In order to push any change in an organization, identifying the business case is truly the first step. So what business outcomes can you expect for more deeply integrating digital solutions within your clinical research programs?

Reduce your costs with digital solutions in clinical research.

The most critical measurement of any business initiative is monetary. It’s also the easiest to quantify. Depending on where you inject a digital solution, the calculation here is easy. The problem is – it is a calculation. This distinction is important, because without calculating the savings that a digital solution provides, all you will see is added cost from licensing and implementation. 

For example, if you implement a solution like Ready for an upcoming trial, you should compare that cost to the prior expense of the in-person activities the solution enables you to eliminate, like:

  • Location rental/contract fees for large meetings you’ve moved to digital (like investigator meetings)
  • Site fees attached to in-person meetings you will no longer pay
  • Travel costs related to being onsite for all activities you’re replacing
  • Time saved by avoiding travel for every employee/team member involved

Producing this simple, yet critical, component of your business case will make it easy for you to say yes to continuing with any newly adopted digital solution.

Increase patient enrollment with digital solutions in clinical research.

It’s well documented that many trials fail to meet recruitment targets. You’ve seen the stats: As much as 86% of clinical trials do not reach recruitment targets within their specified time periods.

But what if you remove many of the most common barriers to recruitment? Remove burdensome things like travel time, or exposure to external environments (like the pandemic right now). 

Or what if you’re able to cast a wider net beyond your site locations by using digital solutions? 

Removing the difficulties that patients face, expanding your geographical reach, and making patient education available in a more digital, on-demand format? You may have adopted digital solutions to get through the pandemic for recruitment, monitoring, or patient education – but these are real impacts you can realize by keeping them.

Support diversity in patient recruitment with digital solutions in clinical trials.

Beyond increasing patient enrollment, patient diversity is another powerful outcome you can manifest by continuing with digital processes. By relying on brick-and-mortar site centricity, you limit your enrollment to patient populations who have access, and often who have convenient transportation. 

If your organization is committed to diversifying patient populations, then you have to shift to a digital approach. Most effective?  Focus on digital recruitment to reach more patients and physicians directly through the many tools and strategies available for outreach. Also prioritize education, and make informed consent more accessible through a digital content tool like Ready.

So where else will you see the biggest impacts in clinical research with digital adoption post-pandemic? 

Area #1: Investigator meetings 

Investigator meetings (IMs) are prime for disruption. With the average IM series price tag for a global Phase III study approaching upwards of $1 million, there’s a huge amount of cost involved. Could it be realistic to move these meetings – even just some of them – to a digital experience instead?

We performed a survey in the life sciences industry around clinical trials before and after COVID-19 completely changed our world. In that survey so far, 68% of respondents said that their organization believed investigator meetings had to be in person before COVID-19 struck.

But now? Only a paltry 15% today believe investigator meetings need to be in person. Even more compelling, more than 74% of respondents feel that investigator training could be just as effective or more so as a virtual event. 

More than 74% of life science professionals feel that investigator training could be just as effective or more so as a virtual event. 

It’s clear that the industry already sees investigator meetings as an area where digital is here to stay, and it’s probably because of these reasons:

  • Delivering the training virtually saves a huge amount of money (see the above $1 million stat).
  • IM planners can measure and assess the actual consumption and mastery of the meeting content when using a digital solution like Ready. Compare this to most in person meetings, where there is no assessment beyond a “present” check mark.
  • Even with delays to trial startup, trial teams can continue to review and reinforce their understanding of the protocol when it’s digital, on-demand, and (ideally) able to automatically prompt the team to re-engage. 

Area #2: Trial Site Selection and Site Initiation Visits

Yes, these are two different areas. But the differing approaches to site selection, along with the myriad of solutions available for site use and site initiation reveals some overlap in opportunities.

The larger the number of sites you need to manage, the more benefit you will receive by moving anything you can to a digital experience. In fact, 77% of our survey respondents indicate that they’re increasing their use of digital tools with regards to site selection. Similar to investigator meetings, by using digital tools, you increase your ability to more accurately assess consumption and mastery of your trial protocol and processes. So a virtual site selection could be a more accurate, and less time-consuming process.

Even more telling, 84% are increasing their use of digital for site initiation visits. So much of these visits can be moved online, especially for sites that are clearly ready to start. Whether you’re using web meetings to initiate, conference calls, or a full, comprehensive virtual onboarding with Ready or something else, site startup activities are a perfect place to continue with digital solutions.

84% of life science organizations are increasing their use of digital for site initiation visits.

Area #3: Clinical Trial Site Training

Really, any clinical operations area that involves the communication of information like the protocol, amendments, SOPs, or other essential documents is something that you should be moving to digital during this pandemic. Learning does not have to stop!

One of the greatest risks to virtual training, however, is distraction. More so than an in person training, care must be taken to engage learners, focus their attention, and reduce the risk they speed through the content, sharing answers to assessment questions, and multi-tasking. Here are some of the most important things that clients of Ready do to ensure success with this:

Area #4: Ongoing Team Onboarding and Training

When you joined your current team, what was your onboarding experience like? Was it guided, paced, and targeted to the particulars of your new environment? Or was it like you’d been dropped into the wild west and needed to find your way out?

Particularly for long-term studies, there will always be change in personnel and team members. So plan for it. Make your onboarding documents and process as digital as possible, and organize and prioritize your clinical tools and assets to simplify site and team personnel changes. Your new team members and your sites will thank you.

Area #5: Patient Data Collection via Wearables in Clinical Trials

With the vast adoption of wearables like smart watches and wristbands, there’s a low barrier to adoption for patients. Plus, wearable devices optimize data collection with their sensitivity and widely-tested calibration. Wearables are a fairly mature market, and it’s something we need to adopt more broadly in clinical research, as Kemi Olugemo, M.D. pointed out in a recent conversation with us.

Despite their low adoption in clinical trials, the current time is a perfect way to collect data remotely like walking speed, seizure detection, or perspiration, as examples. Performing diagnostic and biomarker data collection without subjecting trial participants to a visit is vital now, but prudent for a future where we emerge from the pandemic. 

Even more promising is the possibility of more accurate and consistent data capture can increase the power of your study. Could that mean fewer participants and accelerating the conduct? Very possible.

Make Digital Solutions a Long Term Focus for Your Clinical Trials

It remains to be seen how much digital change will result in true transformation for our industry. But we know that the steps we take now can pave the way for trials that are less expensive, more accurate, more accessible, and more timely. 

Ready by ArcheMedX can help in many of the areas discussed in this blog. So the question is – will your trial team be part of the change now? If so, let us help.