Digital Health Off The Record

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:EU AI Act - High-risk AI in patient safety and clinical decision making (03:30)Quick wins - Lower-risk operational AI and workflow efficiency (05:30)Agentic AI and the accountability challenge (07:00)Human oversight in SAE reporting and protocol deviations (08:30)RBQM and continuous monitoring opportunities (11:00)Synthetic data: what it is and where it fits (12:45)Digital twins and protocol simulation (18:30)Reducing control arms and improving recruitment (20:30)Data quality, model drift, and over-trust in AI outputs (22:30)Next episode, we dive into eCOA - covering implementation considerations, BYOD vs provisioned devices, translations, and licensing.

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:Why R3 is more than just an update - it is a rethink of how trials are designedThe real impact of Risk-Based Quality Management and focusing on what truly mattersHow Digital Health Technologies are now expected, not optionalThe growing role and responsibility of sites when using their own technologyWhat participant centricity actually looks like beyond the buzzwordsWe also get into the practical realities:Where does responsibility sit?How do you assess site-owned systems?And are we creating new burdens while trying to reduce others?R3 sets the direction - but the industry is still figuring out how to implement it.If you are working in clinical trials, digital health, or study operations, this is a conversation you will want to be part of.

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 participate.We cover:- eCOA and why paper should no longer exist in 2026- eConsent - high potential, but still lagging in adoption- Wearables and connected devices - where patients are driving innovation- Telehealth as the simplest and most effective way to reduce burden- The hidden costs of paper and delayed data- Why hybrid models are the reality, not fully decentralized trials- Global challenges - from data privacy to country-specific regulations- Why most teams are not getting full value from the tech they deployDCT is not the challenge anymore. Implementation is.If trials are meant to fit around patients’ lives, the same must be true for sites.Candid takes, no buzzwords, straight talk.Are DCT technologies reducing burden - or just shifting it somewhere else? Let us know.

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 the difference actually means for clinical opsReal-world AI wins that are genuinely moving the needleWhat your organisation must have in place to succeedThe hard conversation: risks, ethics, and accountabilityAI is not coming for your job — it is coming for the 40% of your job you hate doing anyway. But only if the foundations are right.Candid takes, no buzzwords, straight talk.What is the biggest hurdle to AI adoption in your organisation — trust, data quality, or regulation? Let us know.

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 duplicate data entry and endless training refreshers, we unpack the operational reality facing site teams today. With studies now involving 20 plus systems on average, increasing datapoint complexity, and shrinking timelines to first patient in, something has to give.We explore:Why more technology does not automatically mean more efficiencyThe hidden operational layer driving much of the burdenHow data overload is affecting clinicians and study teamsIt is not all bad news. Real time data, improved data integrity, decentralized models and better patient engagement are shifting the industry forward. But are we designing studies with a digital first mindset, or just layering innovation on top of legacy processes?We also debate what “good” could look like. From cohesive site journey design and centralized training models to the potential of AI co-pilots and connected flows, what would actually make life easier for sites?Expect candid reflections, practical examples and honest perspectives on what needs to change if we want digital health to deliver on its promise without overwhelming the people running our trials.Let us know your experiences. Are digital tools reducing burden at your site, or adding to it?

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 should sponsors, sites and technology partners be paying attention to next?Expect candid reflections, practical insights and a few unfiltered opinions as we kick off the podcast and set the tone for the conversations to come.