Digital Health Off The Record

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 sponsors.We discuss:Why eConsent still has not reached its full potential (00:24)What eConsent should mean beyond a digital signature (01:17)How eConsent can improve patient understanding and accessibility (03:45)Why consent should be treated as a workflow, not just a document (05:17)The hidden value of optional consent, data use and sample traceability (07:24)Why consent forms remain too long, complex and difficult to manage (10:27)How digital workflows can support amendments, reconsent and oversight (19:20)Why digital consent is often held to a higher standard than paper (22:17)As with our previous discussions on eCOA and DCT-enabling technologies, the real opportunity is not simply to digitise an existing paper process. It is to rethink how clinical trial technology can make studies clearer, more accessible and easier to manage for everyone involved.

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.

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.

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?