How is eClinical Positioning its Platform Capabilities to Help Sponsors?

In a conversation with Pharmaceutical Executive,Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions, discusses the FDA's shift to a single pivotal trial for drug approvals. Pomerantseva explains that this change aims to provide stronger evidence of efficacy and patient safety, emphasizing the importance of risk-based approaches and AI in trial design and monitoring. She highlights eClinical's platform capabilities, including customizable centralized monitoring strategies and robust oversight across trial portfolios, to enhance efficiency and ensure regulatory compliance.

A transcript of Pomerantseva’s conversation with Pharmaceutical Executive can be found below.

Pharmaceutical Executive: How is eClinical Solutions positioning its platform capabilities to help sponsors design and execute a single pivotal trial?

Vera Pomerantseva: I think we have very strong offerings already, because I think that the pivot to the one trial right will bring lots of efficiency to the industry and will potentially reduce the cost. And the biggest impact is probably going to be on the rare disease, which would really struggle with a two-trial concept.

So, rare disease area is not as standardized as the bigger trials like cardiovascular respiratory so in elluminate platform, we have almost endless capabilities to customize your centralized monitoring strategy to your trial. We do provide standard solutions like anyone else on the market. But the ability to do that custom work in elluminate, I think it stands out.

Another thing which come to my mind as we're moving to that one trial approach, is we have to provide FDA with more evidence and with the proof that we really oversee our trials. And it's not just one trial, it's oversight across your whole portfolio that we're in control of that if something happened, we take immediate action.

And embedding escalation mechanisms, that’s another capability which we have in the elluminate platform, it's actually coming a couple of months. It would provide robust capability for the process oversight across your whole portfolio, across multiple dimensions.

Obviously, we have already had quite the number of capabilities with AI, which help you to explain what is happening behind the data, and we advance AI, which helps you to conduct risk assessment and bring certain points to your attention.

As a risk manager, we’re still very mindful about keeping a human in the loop and respecting the expertise which all of us carry in the industry and making sure that the final decision is still on the expert.