Clinical trials often encounter operational challenges and sponsors and CROs seek effective site-readiness practices. In this interview, Joel B. Selzer, co-founder and CEO, ArcheMedX, Inc., discusses the impact that healthcare technology has on clinical trials, focusing on the development of the company’s workforce readiness platform.

Q: Can you tell us a bit about yourself?

Joel Selzer: I have spent the past 15 years envisioning and delivering innovative technology and data-driven solutions across the life sciences and healthcare industries as an entrepreneur, board member, and advisor. During this time, I have co-founded and led three technology companies, Medical Funding Services, Ozmosis, and currently ArcheMedX. In each venture, we have applied creative approaches to improve the lives of our customers, thousands of clinicians, and most importantly millions of patients.

Q: Can you give us a brief overview of your product?

JS: Ready is an operational intelligence and workforce readiness platform that reduces the risks and costs associated with underperforming clinical trials. The platform enables clinical operations leaders to evaluate and improve the preparedness of project teams and site personnel by analyzing the behavior of each participant as they engage in personalized learning experiences that are designed and delivered within the platform. Ready serves as an early warning detection system to identify risks sooner, ensure resources are more effectively deployed, and enhance staff and site performance.

Q: This product came out of a healthcare and continuing medical education history. What made you choose clinical trials for this service?

JS: We spent the first six years at ArcheMedX powering hundreds of online medical education activities for national medical societies, leading academic medical and research centers, global medical education providers, and major pharmaceutical firms. One of our academic research partners ran into challenges standardizing initiation across a diverse set of study sites and asked if ArcheMedX could help.

We ultimately enabled them to design and deliver an innovative site readiness program powered by the ArcheMedX platform that accelerated site initiation for a neurology focused trial. That effort opened our eyes to the operational challenges thousands of trials encounter and led us to explore the industry further. In the course of our market research, we conducted informational interviews with dozens of sponsors, CROs, and other trial stakeholders and the critical need to more effectively evaluate and improve the preparedness of staff and sites became increasingly clear.

The result was the development and launch of Ready.

Q: We are seeing more technologies coming from healthcare into clinical trials, which is but one part of the overall healthcare picture. Why do you think that is? What impact will that continue to have in clinical trials?

JS: There are a number of macro trends driving the adoption of technology within clinical trials. For example, rising trial costs, increasing complexity, the continued low success rates of getting to market, and the extreme challenges of recruiting and retaining participants are all multiplied by the continued growth of active clinical studies. This creates a great deal of opportunity for technology-based solutions to make a positive impact.

In particular, clinical trials are accelerating the adoption of digital tools and data-driven strategies. Sponsors and CROs are now using advanced data analytics and deep learning to more effectively design and implement clinical trials that result in more personalized and consumable therapies that benefit patients and providers. From digital therapeutics and advanced protocol simulations to data-driven workforce improvement, the industry can more rapidly and accurately analyze novel sources of data that will inform better decision-making, decrease the costs of clinical trials, and provide the right therapies to the right patients.

Q: Investigative site burden is quite often a topic of concern in this industry. Does the implementation of Ready increase a site’s burden of tasks?

JS: Many sites today are already struggling to implement a dozen or more trial applications, ever-changing study tools, and increasingly complex protocols. Adding to this burden, they are rushed through training on each system and protocol and often lack the time and interest to properly focus on critical information. By centralizing and personalizing each training experience, Ready makes it easier and more enjoyable for site personnel to engage in critical content over time, increasing their confidence and interest in the study or tool. Ready can also be integrated via web services with nearly any IT system making it simple to create a seamless user experience and securely share data.

Q: How would you envision Ready changing the way sponsors plan their investigator meetings and subsequent site training?

JS: Ready creates opportunities for sponsors to augment, re-focus, or even replace their investigator meetings, and subsequent site training. By deploying Ready prior to an investigator meeting, the insights it generates can help to focus the meeting on the areas of greatest need and risk. This can result in a more engaging and targeted meeting that accelerates site initiation, better enrollment, and overall compliance.

Ready can be utilized in place of an investigator meeting to significantly reduce meeting costs and provide more measurable data and insights that identify which PIs (principal investigators) are most likely to struggle. The platform can then automatically re-engage any participant to focus on critical aspects of the protocol or other content they may have skipped or struggled with and will continually measure their engagement and response.

Ready can also power a virtual SIV and any subsequent site training, such as protocol amendments and the sharing of recruitment best practices. In each of these use cases, Ready will analyze the unique behavioral data it captures to provide insights that help sponsors focus where additional training, site visits, and/or remote monitoring may be required.

Q: Does Ready impact other oversight practices such as risk-based monitoring (RBM)?

JS: Yes. The operational intelligence and workforce readiness data generated by Ready creates early insight around areas of clinical operation risk and are key pieces of information for any RBM strategy. Since the personalized learning experiences powered by Ready are often delivered during study start-up, the insights the platform provides into the readiness and mindset of participants serve as an early warning detection system that compliments traditional risk-based data and strategies. This unique analysis of behavioral data drives risk mitigation, as well as more effective allocation and deployment of resources that leads to better staff and site performance.

Q: There is also a lot of positive change in the industry to raise the level of education and professional credentials at the site level. How does Ready help sites raise their bar?

JS: More than 40,000 clinicians have already improved their knowledge, competence, and confidence with ArcheMedX and this positive change continues to raise the bar at sites across the globe. By deploying Ready, sponsors and CROs can now accelerate this change by more effectively measuring and improving the competence, readiness, and mindset of their staff and sites. Ready can enable the industry to identify skill and knowledge gaps across roles, years of tenure, certification levels, and therapeutic areas and then target workforce improvement efforts on the segments of staff and sites that need it most.