Author: Molly Bryant

The Evolving Role of Sites in Virtual & Decentralized Trials: Interview with Mary Costello of Medable

Mary Costello talks with Kelly Ritch, EVP of Product and Clinical Research Solutions, about how clinical research site management is changing – and marching towards sites being capable with decentralized clinical trials – in the face of the pandemic.

Mary’s more than 20 years of diverse experience in the industry position her well to provide insight from a variety of perspectives, including management, marketing, and the coordinator’s role.

She shares the new cornerstones of success that have emerged in the face of COVID, and illuminates ways we can all work together to help research sites deliver.

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

Mary Costello

Mary Costello is the Head of Site and Investigator Network at Medable. In her role she works to ensure that the site’s perspective helps to inform development.

Prior to joining Medable, Mary worked in software, clinical research, and marketing at diverse organizations, including Covance, Thermo Fisher Scientific, and eClinical Solutions.

She brings to the table a strong appreciation for the value of the stakeholders’ experience, and is pleased to be working with a female founder for the first time in her career.

Episode Highlights

  • How excellence in site management has changed since the pandemic.
  • Why the sites are still the lynchpin.
  • Why anxiety around decentralized clinical trials is misplaced.
  • How a marketing perspective can serve clinical operations and site management.
  • What sets sites apart that will succeed and sites that will struggle in this new landscape.
  • Why it’s important to assess a site’s tech-readiness and physical situation before handing down directions on how a study will be run.
  • Simply providing a site with technology isn’t enough, so what else needs to be done?
  • Why prevention and preparation beat correction and remediation.
  • How to maximize collected data through follow-up and implementation.

Resources:

Medable
Mary Costello on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

Demystifying Decentralized Clinical Trials: Interview with R’Kes Starling of Reveles Clinical

R’Kes Starling joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss how decentralized clinical trials (DCTs) can expand access to clinical trials and promote patient participation. He shares the personal experiences that motivated him to found Reveles.

R’Kes also recounts a poignant story of a patient who was empowered and given hope through decentralized clinical trials. Further, he describes how he and his company are working to overcome the hurdles on the path to DCTs.

Anyone wondering whether DCTs are right for them will appreciate R’Kes’s take. It unites his personal and professional experiences in a perspective that is both empathetic and firmly grounded in reality.

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

R’Kes Starling

R’Kes Starling, RPh, MBA, is the founder and CEO of Reveles Clinical Services, a technology and service provider working to “bring hope closer to home” by improving access to clinical trials through DCT-focused services. Prior to founding Reveles, R’Kes held leadership roles at McKesson, Coram CVS, and DaVita. Through Reveles, he has become a DCT evangelist educating the industry on both how and why to move forward with DCT.

Episode Highlights

  • The industry and operational challenges facing the adoption of decentralized clinical trials.
  • How inconsistent nomenclature has contributed to widespread misunderstanding of DCT, and how misnomers have slowed adoption.
  • The challenge of change management and how clarity and infrastructure can be an antidote.
  • How decentralized clinical trials can help boost minority representation in clinical trial research, and why shifting those numbers requires time.
  • How sponsors can get started with DCT and what they need to consider.
  • Assessing organizational fit.
  • Why it’s so important to talk with the patients and understand the challenges they face.
  • Why DCT and patient-centric approaches so often go hand-in-hand.
  • How patient engagement is changing, and why clinical trials need to adapt to that.
  • How sites have been forgotten as stakeholders and why they’re still central to clinical development.

Resources:

Reveles’ Decentralized Clinical Trials Grader
Reveles on LinkedIn
R’Kes Starling on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

To Succeed with Virtual or Hybrid Clinical Trials, Listen to Patients and Sites

Interview with Amy O'Sullivan of SCOPE InternationalWe recently spoke about virtual and hybrid clinical trials with Amy O’Sullivan, Director of North American Operations at SCOPE International, an independent full-service CRO serving pharma, biotech, and medical device clients across the US and Europe. The company is headquartered in Mannheim, Germany, with US operations based in Pittsburgh, PA. Here are some of the most interesting excerpts from our discussion:

ArcheMedX:

You’ve had such an interesting career – spanning social services, nursing, site coordination, and managing programs. Tell us about where your current career is focused. 

O’Sullivan:

So much right now is attached to the experience of the pandemic. But even before COVID hit, my interest has been, “how can we do what we do better?” The way we perform clinical trials has been stagnant for a long time. Yes, new tools have emerged, but none have truly been transformational. But considering R2 and Risk-Based Monitoring, there’s really a ton of potential, it just needed an accelerator.

Though the pandemic has been horrible, it has accelerated the transformation that was needed. So my focus has been – and will continue to be – clinical trial innovation so we can bring clinical trials to people across all parts of the country and the globe. You shouldn’t need to live near a big city to be able to participate in a trial and get the most innovative treatments. We should be able to have a diverse population because we can bring trials to patients, and even bring them to patient’s homes. So these have been driving forces.

ArcheMedX:

So how do you approach this transformation?

O’Sullivan:

To be able to do things that are more creative, I’ve been collaborating with eSystems partners and sites that are willing to step forward. What we have now is a way to run fully virtual clinical studies when needed, or hybrid clinical trials when appropriate. We can focus on quality, by focusing on the risks that matter. We can monitor in a way that makes sense, let sites use their resources to take care of their patients, and have monitors provide support to the sites because they’re not spending every hour of their day checking data points, but instead checking what matters, and helping sites deliver the best experience to the patient.

Because that’s what it’s all about – clinical trials succeed when sites are able to succeed and we listen to patients and what they need. Especially virtual, hybrid, or decentralized clinical trials.

Transformation is my focus. It’s been a long time in coming. If we’re going to bring more treatments to market faster, innovation is not an option.

ArcheMedX:

Tell us more about the strategies that you’re using for virtual and hybrid clinical trials that could work for organizations who don’t know where to start.

O’Sullivan:

The place to start – what do subjects and sites need? You can’t just jump into virtual or hybrid clinical trials and choose what to virtualize casually. You need to be thoughtful – it needs to make sense. There are dozens or hundreds of eSystems out there – whether they solve a problem for you is what matters. 

You need to look at your protocol to see what you really need. When do you really need the patient there and when do you not? And the answer for that needs to be driven by the physician on the front line, because they know what they will be comfortable doing. So you have to listen, you can’t just decide from the 30,000 foot level of the Sponsor or the CRO.

Part of what we’ve done at SCOPE is we’ve been developing relationships with various sites that say they do virtual research or want to do virtual or hybrid clinical research. We’ve been listening to them and gathering from them inputs about what works and what doesn’t. In parallel, we’ve been working with some sites that are willing to innovate to understand what they really need to do to shift. Because a fully virtual clinical trial is actually a very tough thing to run. 

Ultimately, you must go to the physicians and to the sites, and listen to the patients – then select the eSystems that really facilitate the process.

ArcheMedX:

What are the specific challenges you see with virtualizing clinical trials?

O’Sullivan:

You don’t have everyone under one roof. So you have to ask, what are the impacts? One of the biggest impacts is that you can’t physically touch a patient. You need to know if you truly need the physical exam or not. Don’t pretend you can do something virtually that you can’t.

If you can do that virtually, then you need a telemedicine solution that is going to work for you and that is cost-effective, because some solutions may be cost-prohibitive.

Another challenge is adjusting for a lack of travel. We discovered that the more that is eSourced, the less that has to be checked into the EMR. So we have partnered with one eSource company in particular, so that people can do their job remotely. A physician who is working remotely can log into an eSource tool, log a contact note, and move on. We’ve eliminated multiple steps. 

You have to make things digital, and simple, and eliminate those middle steps that are unnecessary.

ArcheMedX:

We spoke earlier about how clinical trial Sponsors want to make the study startup digital. So much of startup is training. What strategies do you use in how you help your Sponsors train and equip clinical trial teams?

O’Sullivan:

This is something we’ve had to pivot. When you move from the in-person investigator meeting, or the in-person SEV or SIV meeting, there’s a lot of things you can do hands on. You can read people’s faces, and people were demonstrating their understanding in ways that we didn’t even realize was happening until we went virtual.

We have a lot of sites that are semi-virtualized out of necessity, and a trial team that’s the same. We have a huge number of eSystems, and we’ve pivoted to a risk-based model. This idea of just presenting a Powerpoint and saying “this is how you do it” – it just doesn’t work. 

There are so many nuances; you need to know 3 or 4 eSystems, and how to cross-reference them. And the thought that a half-hour Powerpoint presentation is going to make that clear is just untrue. And what that results in is a large likelihood of early errors and site questions, and it’s understandable. You can’t expect someone to have a nuanced understanding of all of these systems. 

So what we’ve moved to is return demonstration. You have to teach the way you know people learn. You retain about 20% of what you hear, and maybe 40% on a good day, but the point at which you have to actually show someone what to do, that’s when it sticks.

It means that when we’re doing our SIVs we’re moving away from Powerpoints, we’re watching to make sure they’re logging in and walking through. If you don’t, you’re going to get a phone call because you didn’t teach them well enough. 

That’s something you can do well when you’re on-site but it’s something many aren’t doing well in a remote setting. 

And this is one of the most intriguing things – when you get the same question from multiple sites, you can see what in your training material is not good enough. If say, 25% of sites are struggling with something that is a critical teaching point, we can modify that content and redeploy it. The data that comes out of that is precisely where we want to go.

As eSystems grow, the need for this grows exponentially.

You can target what critically matters. Every protocol has a pressure point. And those making sense is a must, you don’t want those pressure points to get lost in a presentation. 

ArcheMedX:

If we dig into the remote investigator meeting, or training clinical trial site staff, what are the real problems you’ve seen emerging?

O’Sullivan:

People are comfortable and they want to stick with what they’re used to. If you can get over the mindset of change, it’s very solvable. 

When you virtualize – whether training, or anything else – it needs to be interactive. When you’re in person, you know who’s paying attention and who isn’t. It may be as simple as expecting everyone to have their camera on. You have to be able to “read the room” to know that people are engaging as you would around the table. 

The first few months of COVID it was really basic; we had to get people to step back and say, “this is not a temporary change – I need to embrace this.” That’s been 60-70% of it. And if you have a good platform for meetings, and everyone is using it and talking, it doesn’t have to be that different. 

And in some ways, we can be more available. A year ago, I didn’t do face to face meetings with sites – but now, I do virtually. And that’s a positive thing.

ArcheMedX:

I think you’re right – many people were very resistant to shifting to virtual meetings at first. Did you find that clinical trial sites struggled to change?

O’Sullivan:

Moving to the virtual and remote world – sites were uncomfortable for a very good reason. More burden was put on the site. They were expected to do more, but support wasn’t put in place. Sites are coming along as we’re able to make things easier for sites. 

CROs were making it burdensome and there was pushback because patients were more important than the CRO’s processes. But what we’ve been able to do is allow them to have on-demand support – like letting them show us the lab kit and ask where to place a sticker, or pulmonary function test and taking equipment out of the box and walk through how to use it. We have to not just say we’ll do it, but make it your business model – be more supportive through virtual meetings. 

ArcheMedX:

So the solution to virtualization in clinical trials really boils down to support.

O’Sullivan:

It comes down to support, and the fact that you’re providing solutions. Don’t just employ bells and whistles because they appeal to you and you like the idea of them. Do something because it works. 

ArcheMedX:

What would be your advice for clinical operations leaders in the next six months?

O’Sullivan:

Embrace the progress and the innovation that has come because of the pandemic. We all have to live through the horror, but there has been really great progress. We’ve become more patient-centric, and more site-centric. We’ve been able to use innovation to deliver to a much broader population. Be willing to persist, and don’t revert. 

I was just in a meeting, and we ended with “what do end users need to be able to able to their job well?” We constantly ask, what do users need to do their job well, so they can enroll fast, and activate fast. When we put proposals together, we believe that Sponsors will embrace this thinking. It will increase quality and drive down costs. If you improve quality, trust that cost will reduce accordingly.

Focus on patient and site needs, and success will follow. I believe that whole-heartedly. It’s always been Sponsors telling CROs, CROs telling sites, sites telling patients…that’s a completely wrong approach. Focus on patients, and focus on site needs and success will follow. And that’s how we will find the path forward to success with decentralized and hybrid clinical trials today – and virtual trials in the future.

ArcheMedX:

Amy points to the need for Sponsors and CROs to focus not just on what sites are doing, but how best to enable and support them. One way to do so is to employ tools that translate site activities into intelligence – that reveals where the sites are struggling. Learn more about our platform, Ready, and how it can help you as you begin to embrace hybrid or decentralized clinical trial activities.

4 Ways CROs Can Help Sponsors with Clinical Trial Readiness

When a Sponsor chooses to engage with a contract research organization (CRO), the Sponsor team expects quality and performance in return for their investment. CROs are in business to conduct trials – and offload the work from the Sponsor’s side. So why are so many trials fraught with early hiccups? The truth is that there’s limited clarity – and agreement – around what it means to be fit to start, or clinical trial readiness. Most Sponsors have no process for that readiness – and unfortunately, neither do most CROs. 

We recently conducted a survey which revealed that 78% of clinical operations leaders say they need to improve how they identify sites that are ready to conduct a clinical trial.

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 a fast start up is the best way to counteract the well-documented growth of clinical trial delays. 

Thus, creating a center of excellence around clinical trial readiness is a huge opportunity for CROs to carve out a differentiator and value proposition.

So how can a CRO best help sponsors with clinical trial readiness? There are four main ways:

  • Lead Sponsors to a better understanding of what clinical trial readiness means.
  • Simplify how you measure and remediate site readiness.
  • Provide your Sponsors full visibility into site (and trial team) readiness.
  • Use your clinical trial readiness measurement process to uncover and address risk areas.

Lead Sponsors to a better understanding of what clinical trial readiness means.

What does it really mean to be ready?

It’s imperative that a CRO partner help Sponsor clients to answer this question. A leading CRO should help the Sponsor understand that clinical trial readiness can be defined, and measured. 

First, clarify that readiness is a measure of how prepared an individual, team, or site is to perform. Then, identify what that measure should include, such as:

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

In the past, most trials have had little rigor around site selection, using various dubious methods. That doesn’t have to be the case, because if a CRO and Sponsor can establish expectations, they can measure individuals against those expectations.

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

Simplify how you measure and remediate clinical trial readiness.

Before COVID-19 impacts hit, most life sciences organizations felt that they were effective in identifying site readiness and addressing issues. 

In fact, the survey I mentioned earlier revealed that 76% felt they were effective in identifying which sites were ready to start recruiting. But when probed more deeply, that confidence fell.

Markedly fewer, at 56%, felt confident they could effectively measure site understanding of inclusion and exclusion criteria. 

Fewer still, at only 51%, felt confident they could measure which sites understood investigational product and sample management pre-COVID. 

Now, the pandemic has changed perceptions dramatically. Now that in-person visits and meetings are greatly reduced, trial teams can’t make decisions on gut feeling. 

So now is the perfect time for CROs to establish capabilities around measurement of sites’ capabilities and readiness to start. To do so, a CRO should craft a plan for what metrics can be assessed for site staff and trial team members. One of our recent blogs covered some of these clinical trial readiness metrics for site selection

CROs who use Ready are able to tap into these metrics to create a consistent readiness score for individuals, sites, and teams. Using these metrics, or the readiness score from Ready allows a CRO to:

  • Prioritize sites for early and subsequent start based on likelihood of performance.
  • Simplify the transition from subjective to objective site selection for a Sponsor.
  • Greatly reduce the work involved in site selection by automating it.
  • Identify specific areas for remediation by individual and site.

This final point is important – because though a site may not be ready to start right away, some individuals and sites will only need a little additional help to become ready. Using more rigor to assess individuals like we do with Ready makes it crystal clear who needs what help.

 

Provide full visibility into clinical trial readiness

One powerful way to help Sponsors is to provide real-time visibility into the status of the trial, and that begins with site readiness.

Imagine reducing the questions from a Sponsor’s team because they can view information in real-time. Imagine exposing the level of confidence and capability for critical staff like the current study coordinator, the principal investigator and sub investigators. 

You may wonder how this is done. Once you’ve determined an approach to measurement (by choosing what to measure, and what metrics to use), a CRO must find a way to measure those metrics. 

There is so much opportunity for data sharing available with digital clinical trial solutions today. If you are using technology to assess your sites, you can expose that progress data to your Sponsors.

CROs that do this deploy a remote interactive experience to prospective sites using a tool like Ready. Using the clinical trial protocol synopsis and key questions, CROs observe the site personnel engage with the content. 

In real time, the Sponsors and CROs measure their readiness and fit automatically. As a bonus, these Sponsors and CROs also gather key inputs about the viability of the protocol first-hand.

CROs and Sponsors can quickly uncover the site personnel strengths and weaknesses. Further, they can see engagement levels, and how sites rank vs. other potential sites.  This directly enables a CRO 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.

 

Identify site and individual risk areas early.

Shockingly, 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 most CROs wait to address the problems until after they appear – instead of trying to prevent problems.

Some might suggest that additional clinical trial team training will reduce the downstream delays. That could be true but why put every site and staff member through additional training? Wouldn’t it be better, faster, and possibly cheaper to identify risk areas before you start with a clinical trial site?

The best way to prevent clinical trial delays is to find potential risks before they erupt. 

Measuring clinical trial readiness by site allows you to start your trial with sites that are less likely to experience problems. 

For any site risks you identify that you can address, you will be able to revert to the remediation plan you established. 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.

When you know where the risks are, you can address just those areas. Reduce the work that you put in – and that sites put in. And invest only in those sites that are high opportunities to achieve readiness.

 

Sponsors want to improve clinical trial readiness. If CROs make it a focus, they can scale that knowledge across their various Sponsors.

The entire industry has always struggled with effective site training and needs better approaches — regardless of the pandemic.

According to Tufts CSDD, nearly half of all sites under-enroll or fail to enroll a single patient, forcing clinical trials to increase the planned enrollment period by 94% to meet targets (Source: Tufts CSDD, 2017). 

There is huge room for improvement. And we can solve this problem if we can be more prescriptive in identifying which sites are truly well-equipped and ready to enroll patients. 

Sponsors have clearly indicated that better clinical trial readiness is a priority for them. And if CROs take the lead on improving their approach to this, they can scale the improvements across the industry faster. 

Conversations in Clinical Trial Readiness: Kunal Sampat of Ceribell

Kunal Sampat joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss the changing landscape of clinical trial operations. An experienced Clinical Operations Director, Kunal shares his key learnings from 2020 and elaborates on some of the successes and challenges he’s seen this year. Industry stakeholders from CROs to site managers to sponsors will benefit from Kunal’s thoughtful advice and informed take on the current and future state of clinical operations.

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

Kunal Sampat

Kunal Sampat is the Clinical Operations Director at Ceribell. He earned his undergraduate degree in electrical engineering and computer science, and brings an enthusiasm for technology to his work. He has held positions in both clinical data management and project management over the course of his career. Through this experience, Kunal has developed a holistic understanding of clinical trial management and a strong belief in the value of teamwork and collaboration.

The passion for helping people that drove Kunal to a career in clinical research also compelled him to create a free resource for others in the field. Kunal founded and hosts his own podcast, Clinical Trial Podcast, in which he interviews industry experts and shares his wealth of knowledge.

Episode Highlights

  • Why it’s vital to adapt—during the pandemic and always.
  • Why clarity around workflow is critical to adaptation.
  • What sponsors and CROs can do to reduce the burden on their sites, and why it’s their responsibility.
  • How “making the sites our heroes” can help with patient recruitment.
  • The importance of creating ways for your sites to exchange information with each other.
  • How the CRA role is evolving.
  • How tech vendors can address the biggest obstacle to adoption.
  • Why video is the best tool for training and communication, and how to leverage it.
  • What the future of effective clinical operations will look like.
  • Kunal’s favorite resources for staying up-to-date.

Resources:

New Playbooks Authored by ArcheMedX Explore Digital Transformation in Clinical Trials

ArcheMedX, a leader in behavior-based learning and operational insights for life sciences organizations, announced the release of two new whitepaper companions to its recent report, “COVID-19’s Impact on Virtual Tech in Clinical Trials.” These whitepapers, focused on clinical research organizations and clinical trial sponsors, respectively, are intended to be playbooks that lay out the specific actions each group should take based on the report’s findings.

Each whitepaper reveals five immediate priorities across the clinical trial cycle where sponsors and CROs must focus. The playbooks also provide access to detailed resources that explore how to adopt digital initiatives supporting each priority.

“The data we uncovered revealed a dramatic shift in the perceived need to virtualize trial activities by CROs and trial sponsors,” said Joel Selzer, CEO and co-founder of ArcheMedX. “We released these playbooks to provide each group with tailored insights and immediate steps they can take to digitally transform their clinical operations.”

To identify the insights, the ArcheMedX team surveyed clinical operations leaders across pharmaceuticals, biotech, and clinical research organizations earlier in 2020. The team delved into how these leaders planned to adopt virtual solutions to advance clinical research in the current and post-pandemic environment, and ultimately produced the 45-page report with the findings.

After discovering that Sponsors and CROs had different priorities, ArcheMedX determined to release more actionable content to help bridge that gap.

According to Kelly Ritch, EVP of Clinical Research Solutions at ArcheMedX. “Since sponsors have made it clear that they’re expecting to adopt virtual technology throughout site selection and study start-up, it was surprising to see some areas where CROs need to catch up. These whitepapers are impactful because they don’t just expose areas for improvement at both CROs and sponsor organizations – they actually lay out the process to improve.”

ArcheMedX provides a software platform, Ready, that enables CROs and Sponsors to predict and improve clinical trial site and team performance. The findings in the report mirror the increased adoption Ready has experienced across the industry as the platform reveals precisely which sites, teams, and individuals are likely to be high performers and enables CROs and Sponsors to remediate potential risk areas — earlier than ever before.

Whitepapers are available now

The whitepapers, focused on clinical research organizations and clinical trial sponsors, respectively, are available now for download.

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Marketing to Healthcare Providers? Create Content Truly for Them

Relationships are built over time. However, with the inability to meet face-to-face, many life sciences commercial teams are left wondering how they should be marketing to healthcare providers in this new world.

Unfortunately, we have been truly disrupted – not only in our work environment, but in what healthcare providers (HCPs) want. A recent research report by Accenture revealed that 65% of HCP meetings with sales reps are now virtual and 43% of HCPs said that they are currently restricting who can enter the office for professional reasons. More importantly, many HCPs expect it to stay this way for the foreseeable future.

This is good news for commercial teams that are able to adapt. Virtual tools mean that marketing to healthcare providers can be automated more than ever before. Commercial sales teams can instantly connect with prospects (and do so more frequently). This means that relationships can continue to form – and even accelerate. However, it is going to take work to make this transition in your team.

Training and equipping your commercial team to be successful is one of the keys to success. 

However, there is more work to be done. If we want to be successful selling and marketing to healthcare providers, we must meet HCPs where they are. Then we must deliver what they need to succeed in their own roles in order to smooth the path for our sales teams to engage more effectively. 

It’s going to be difficult to stand out amid the constant onslaught of email marketing, webinars, and online sales demos. Therefore, innovators will take a different approach and go directly to the source, the HCPs, to discover how best to support and reach them.

To do so, there are a few steps you must take.

  • Understand What Healthcare Providers Want
  • Develop a Fully Virtual Content Toolkit for Selling and Marketing to Healthcare Providers
  • Launch Your Content Toolkit and Reveal Healthcare Provider Insights to Your Team

Understand What Healthcare Providers Want from You

With this shift in the way HCPs want to communicate with life science companies, you must spend the time to uncover not only how HCPs want to communicate, but what messages will stand out amid the digital noise.

The same Accenture report referenced above revealed overwhelmingly that HCPs want pharmaceutical and biotech companies to go beyond product knowledge. They need help, and they need trusted advisors.

One finding that the Accenture report revealed was that HCPs greatly value additional education and training that go beyond product knowledge, like best practices for treating patients remotely. Developing content and training that demonstrates clear value will ensure your messages stand out. To discover what that looks like, you should:

Research

Meet with a few HCPs individually to discuss and identify what they really need to learn about, besides your products. 

Ask: 

  • How can we help make this time easier for you?
  • What topics do you need more information about – besides products?
  • What best practices do you need help discovering?
  • How can we best deliver content to you?

Validate

Survey a larger group of HCPs to confirm what you’ve learned through interviews. 

Ask: 

  • Are these topics indeed valuable to you? 
  • Which are the most important to affect your ability to perform?
  • What are the best methods for delivery?

Refine

You may already have access to this type of research, otherwise this research and validation can be done within a couple of months. The data will be incredibly valuable to help you develop a plan for a virtual content toolkit. This will be the new foundation on which you will equip your sales team to become trusted advisors to their HCP customers.

Develop a Fully Virtual Messaging Toolkit for Marketing to Healthcare Providers

Like all of us, HCPs are facing difficult challenges and transition – but with the added complexity of caring for some of the most vulnerable members of our community. Their work is – quite literally – life-or-death. 

This stress point is a major opportunity for commercial teams to develop resources and support content to enhance their ability to perform at their optimum levels. And it all starts with the findings you uncovered from the interviews and surveys. 

Planning the Healthcare Provider Marketing Toolkit

Based on the information you’ve gleaned from the market, you now have enough information about what HCPs want – and how they want to receive it. 

There are many ways to develop a content toolkit, but there are a few things you must include:

  • Topic pillars. The topics you’ve identified from your research that HCPs want and need from you. 
  • Messaging Arcs. At the highest, and most succinct, level – what is the primary message you want to convey through each topic area?
  • Assets. The content, like videos, presentations, or slides that you will produce for HCP consumption in each topic area.
  • Distribution & Insight. How you will distribute the content to HCPs in a simple experience that allows you insight into their engagement.

It is this last item – Distribution & Insight – that provides the greatest opportunity for your sales team. That’s because if you choose a distribution method that not only delivers content, but tracks HCP consumption and behavior, your team will be able to clearly prioritize outreach. Plus, they will be equipped to lead with a targeted message for every interaction.

Enabling a Content Toolkit

So what does it take to build out this toolkit, and to distribute it?

For clients using Ready by ArcheMedX, most of the work has already been done by your team in developing the messaging arcs and assets themselves, based on the topic pillars. 

Distribution and behavioral analysis is handled by the Ready platform, but there are other tools that you can use to create a more basic content portal for your HCPs and more limited options to assess their engagement. 

The critical requirements that you must have in any tool are:

  • Ability to quickly deliver multiple types of content on-demand. Expecting HCPs to adhere to a scheduled webinar or to consume one form of content will reduce engagement.
  • Ability to not only track, but analyze, HCP interaction and engagement with the content. Human behavior is revealing and the behavior HCPs show around your content can be illuminating.  
  • Consumable insights that show which HCPs are ready for interaction with the sales rep, and more specifically how reps should prepare for and focus the interaction.

Building these assets and developing the toolkit will take some time, but once planned, it is an ideal opportunity to begin transitioning your sales team into their new approach to virtual selling. 

Give Your Sales Team a Deep Understanding of the Toolkit

To truly transform your sales team into a group of trusted advisors, you will need to equip them with knowledge and confidence across your content toolkit, using your chosen technology and tools, and how to sell consultatively. 

But on your team are a lot of different personalities, who are located in diverse locations, who all learn at different paces, have various learning styles, and are interested in different aspects of the content.

For these reasons, it’s ideal to deliver transformational sales content to these reps virtually, and on-demand. For more information on how to do this, we’ve prepared a new whitepaper to guide you through this process.

Launch Your Content Toolkit and Reveal Healthcare Provider Insights to Your Team

You already have a good idea of what HCPs want and need to be successful, based on the early research. And you’ve worked hard to do a great job of meeting their needs with your content toolkit. 

The final step is to roll it out to your HCP territories as a new set of content that will support them as they move forward with the changes they must make.

But though releasing the content toolkit may be complete, the benefits are only just beginning. That’s because the digital marketing to healthcare providers with such content opens up unlimited capability for you to glean insights on each contact’s behavior.

Upon launching your content toolkit you can utilize a variety of data products to identify general engagement trends. If you’re using a more advanced analysis tool like Ready by ArcheMedX, the platform’s predictive insights will enable you to discern individual HCP preferences and behavior based on how each HCP engages with specific topics and resources. With these insights, your sales team can strategically approach how they interact with each HCP using a targeted message or resource. 

Perhaps an HCP hasn’t been a high prescriber previously? Content toolkit insights will reveal if that’s because they lack understanding and need help. 

Perhaps an HCP has recently dropped their level of prescribing? Insights could show that they may have understanding, but lack confidence in when your treatment is best prescribed.

Perhaps an HCP has been a high prescriber and engages with everything you provide in your toolkit. This could be an ideal HCP to highlight for new content as a testimonial or health influencer.

These are just a few examples of the new types of insights the trusted advisor rep can use. And armed with this information, they’ll be able to better understand their HCP territory, prepare for every call with specific information that will add value to the HCP’s practice, and fully transform into a virtual selling powerhouse.

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Clinical Innovations Summit has gone virtual in 2020 – join us there!

Most, if not all, industry events have gone virtual in 2020. Clinical Innovations Summit is the most recent one to convert to an online setting, and it’s now combined with SCOPE Europe, usually held in beautiful Barcelona, Spain.

The ArcheMedX team is excited to be a cornerstone of this year’s Clinical Innovations Summit content – as we shine a spotlight on the innovation that must take place in our industry to move us past COVID.

On Wednesday, 11 November, our own EVP of Product and Clinical Solutions Kelly Ritch will team up with PRA Health Sciences on a session titled:  How PRA Health Sciences Virtualized Clinical Operations Performance Management.

This session will cover the reality that for many clinical operations teams, the amount of time spent on evaluating, discussing, and remediating team performance is overwhelming. However, PRA Health Sciences sought to virtualize performance management in order to: 

  • Better understand team members’ actual performance and ability to grow in their role
  • Help managers to prioritize team members’ remediation more accurately
  • Reduce workload by identifying unnecessary review activities
  • Streamline and automate individual remediation and upskilling

Join this session to learn how PRA built the business case for this undertaking, the process they used, and the outcomes they’ve realized from success.

Also on Wednesday, our CEO and Co-Founder Joel Selzer will join other industry experts on a break out panel titled: New Approaches to Improving Site Selection.

In this live breakout, the panel will discuss topics across three main areas:

  • Data: Novel data types and overcoming challenges to maximally leverage them
  • Relationships: Collaborations with internal and external groups, success stories, new opportunities to build valuable relationships
  • Wisdom: Challenges with bringing prior learnings to bear on future site selection planning and success stories in overcoming them

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, clin ops execs, 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.

We’ll also be available within the conference site throughout the event for discussion.

See you online!

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: https://www.info.archemedx.com/virtualize-clinical-operations-performance-management

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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.