Digital Health Off The Record

Clinical trials cannot run without research sites and participants. Yet both can end up carrying significant costs while waiting to be reimbursed. In this episode of Digital Health Off the Record , Edwin and Farrell explore the often-overlooked realities of payments in clinical trials. From site budgets that fail to capture the true workload to patient expenses that can become barriers to particip...

Patient centricity is not a new topic in clinical trials, but it is one the industry still needs to keep coming back to. In this episode of Digital Health Off the Record , Farrell Healion and Edwin Cohen explore why incorporating patient voice earlier in study design can make a real difference to recruitment, retention and the overall patient experience. We discuss how patient input can help reduc...

eConsent has been discussed in clinical trials for years, but it still feels underused compared with other patient-facing technologies like eCOA. In this episode of Digital Health Off the Record , Farrell and Edwin take a practical look at what eConsent really means, why it should be more than a PDF with an electronic signature, and how it can improve the consent experience for patients, sites and...

eCOA has been part of clinical trials for decades, but it still has not reached its full potential. In this episode of Digital Health Off the Record , Farrell and Edwin go back to basics on electronic clinical outcome assessments - what eCOA actually covers, how it differs from eDiaries and remote patient monitoring, and why it is about much more than just ePRO. They also get into the practical si...

AI is moving fast, but clinical trial regulation is still catching up. In this episode of Digital Health Off the Record , Farrell and Edwin explore how AI fits within GCP today, even when it is not explicitly covered in ICH E6(R3). They break down what is usable now, what is higher risk, and how to apply existing regulatory principles as guardrails for AI adoption in clinical trials. What we cover...

ICH GCP E6(R3) is now coming into effect across key regions like the UK and Canada and has been in Europe for months - but what does it actually mean in practice? In this episode of Digital Health Off the Record , Farrell Healion (OptiTrial) and Edwin Cohen (C&Flow) break down the shift from traditional trial thinking to a more modern, risk-based, and technology-enabled approach. We explore: W...

Decentralized clinical trial technologies had their moment during COVID. But are we actually using them well today? In Episode 4, Farrell Healion and Edwin Cohen break down where DCT really stands in 2026 - cutting through the narrative of fully remote trials to focus on what actually works in practice. Because the goal was never to replace sites. It was to give patients more flexible ways to part...

Everyone is talking about AI in clinical trials. But are we actually ready for it? In Episode 3, Farrell Healion and Edwin Cohen go under the hood — cutting through the buzzwords to look at what AI adoption in clinical trials actually requires. Because the biggest barrier is not the technology. It is the 20 years of technical debt we are trying to build it on. We cover: ML, LLMs, and GenAI — what...

In Episode 2 of Digital Health Off The Record, we turn the spotlight onto one of the biggest tensions in modern clinical trials: site burden. Digital health technologies promise efficiency, better data, and improved patient experiences. But what does it actually feel like on the ground for sites? Are we reducing burden, or simply shifting it? From device overload and fragmented systems to duplicat...

In our first episode of Digital Health Off The Record, we unpack the biggest themes and takeaways from SCOPE Summit 2026. From Agentic AI and digital endpoints to implementation realities and inspection readiness, we share what was actually discussed in the rooms, not just what made the slides. Where is the industry genuinely progressing? Where is the hype running ahead of delivery? And what shoul...