Digital Health Off The Record

Another feasibility questionnaire lands in a site’s inbox. The same questions, another blank form, and often no feedback on what happened next.

Is this really how we want to start a clinical trial partnership?

In this episode of Digital Health Off the Record, Farrell Healion and Edwin Cohen discuss why site feasibility needs a rethink. From repetitive questionnaires and unrealistic recruitment expectations to missing protocol details and months of silence, we explore what the process asks of sites and whether it gives sponsors the insight they actually need.

We also discuss why past recruitment numbers need context, how relying on familiar sites can overlook new opportunities, and what better communication could change.

Farrell shares how he is approaching these challenges through OptiSite, with reusable site information, protocol synopsis feedback and clearer visibility across sponsors, CROs and sites.

In this episode:

• Why moving a questionnaire online doesn’t solve the whole problem.
• How limited information affects recruitment estimates.
• Why zero recruitment doesn’t tell the whole story.
• Making room for new and community research sites.
• Using technology to reduce repeated work and support better decisions.
• Building trust from the first feasibility conversation.

Less time repeating answers. More time for patients.

Learn more about OptiSite: https://optitrial.ai/optisite

Subscribe to Digital Health Off the Record for candid conversations about clinical trials, digital health and the people making them work.

“Did you already ask a site?” And, just as importantly, “But did you also listen?”

Physician and principal investigator Viviane joins Farrell and Edwin to share the reality of running clinical trials after almost 30 years in research.

From repeated feasibility questions and delayed payments to an eConsent workflow that left a patient stuck between two systems, she explains where trial processes create extra work for sites and patients.

We explore investigator retention, fit-for-purpose training, the risks of assessing sites without context, and why meaningful oversight takes more than another signature.

What does it actually take to get clinical trial technology, connected sensors, devices and study supplies into the hands of sites and patients?

In this episode of Digital Health Off the Record, Farrell Healion and Edwin Cohen are joined by David Loughborough, Founder of LogiDCT, for a practical look behind the scenes at clinical trial logistics.

From supply chain visibility and customs challenges to wearables, sustainability and the future of DCT delivery, we explore the operational infrastructure that has to work before any clinical technology can deliver value.

Topics discussed:

04:04 - How DCT logistics have evolved
10:00 - The biggest challenges in clinical trial logistics
13:00 - Why supply chain visibility matters
17:47 - Customs and global clinical trial distribution
23:09 - Complex protocols and logistics planning
26:39 - The future of DCT logistics and "trial in a box"
29:31 - Wearables and patient engagement
31:49 - BYOD, sustainability and reducing unnecessary shipments
35:31 - Future technology and AI-enabled logistics
39:18 - Why logistics is the invisible layer behind clinical trials

If you work across clinical operations, DCTs, digital health, connected devices or clinical technology, this episode gives a look at the operational work that happens behind the technology everyone sees.

What does it really take to build a startup in the clinical-trial space?

In this episode of Digital Health Off the Record, Farrell Healion and Edwin are joined by Ashton, Founder and CEO of SheppAI, for an honest conversation about building in a complex, risk-averse industry.

Ashton shares lessons from his journey: finding genuine customer pain, testing ideas, earning trust, working with design partners, and staying focused when things do not go to plan. The conversation also explores why even well-funded partnerships can fail, and the importance of relationships, resilience, and solving problems rooted in lived experience.

Featuring Ashton, Founder and CEO of SheppAI.
Hosted by Farrell Healion and Edwin.

#ClinicalTrials #DigitalHealth #HealthTech #ClinicalResearch #Startups

In this episode

01:29 | The challenge of breaking into clinical trials
04:40 | Finding product-market fit: seek invalidation, not validation
07:09 | Building credibility and trust with prospective customers
09:15 | The problem SheppAI is solving for sponsors and vendors
15:15 | Testing a new product idea with end users
16:13 | Using prototypes to shape a focused pilot
19:05 | Why real-world feedback matters
21:04 | Building design partnerships through your network
24:24 | Why startup failures offer the biggest lessons
25:18 | When even major partnerships fail
30:29 | Staying aligned on a shared vision
33:24 | Closing advice for aspiring founders

Clinical trials increasingly depend on a complex network of technology and service providers. But with so many options, how can sponsors identify the right vendor rather than simply the best sales pitch?

In this episode, Farrell Healion and Edwin Cohen explore the clinical trial vendor selection process from both the sponsor and vendor perspectives. We discuss how to define the need, navigate the RFI and RFP stages, evaluate suppliers objectively and test whether a solution can genuinely deliver.

We cover:

• Defining the business, study and user needs before approaching vendors
• The difference between an RFI and an RFP
• Building meaningful evaluation criteria and involving the right stakeholders
• Why sponsors should insist on live, use case-based demonstrations
• Turning subjective feedback into an objective selection decision
• Contracting, governance and setting the relationship up for success
• Why good vendor selection depends on dialogue, context and honesty from both sides

Whether you are selecting a specialist provider for one study or building a long-term preferred vendor partnership, this episode offers practical advice for making a better-informed decision.

Patient recruitment remains one of the biggest causes of clinical trial delays. So why, after decades of investment, innovation and expertise, does the industry still struggle to solve it?

In this episode of Digital Health: Off the Record, Edwin Cohen and Farrell Healion are joined by patient recruitment specialist and author Ross Jackson.

Ross challenges the idea that recruitment is primarily an advertising problem. The conversation explores why recruitment and retention must be considered from the earliest stages of trial design, the critical role sites continue to play, and why opening more sites is rarely a complete solution.

The discussion also looks at recruitment costs and commercial models, the growing use of AI, and how digital twins and synthetic control arms could transform the number and type of patients required for future trials.

What we cover:

• Why recruitment must begin with trial design - 01:13
• How patient outreach and access have evolved - 04:04
• Why sites remain central to recruitment success - 13:20
• Understanding site performance and where to focus - 17:26
• The cost of recruitment and different pricing models - 20:10
• How AI is changing patient identification and engagement - 26:04
• Digital twins, synthetic controls and the future of trials - 30:24
• Designing trials for patients, not around them - 34:00

Ross leaves us with a simple but powerful principle: design every trial as though it were for you or someone you love.

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 participation, they discuss why getting payments right is essential for sustainable and accessible research.

Building on previous conversations about site burden, patient-centred trial design and fragmented technology, they also consider whether digital payment tools are genuinely simplifying the process or creating another system for sites to manage.

In this episode, we cover:

• Why timely and fair site payments matter - 00:51
• The hidden work that trial budgets can overlook - 03:02
• Payment delays and their impact on site cash flow - 14:37
• Patient reimbursement and barriers to participation - 19:12
• Technology, ethics and planning for long-term costs - 23:58

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 reduce unnecessary burden, improve protocol design, support more meaningful inclusion criteria and make trials work better around real life. We also look at where digital health technologies, DCT capabilities, patient feedback tools and patient engagement roles can help - and where simply adding more technology risks creating the opposite effect.

As always, this is an honest conversation about what the industry is getting right, where we still fall short and how we can design better trials for patients, sites and sponsors.

In this episode, we cover:

• Why patient voice matters for recruitment, retention and study success 00:25
• How earlier patient input can improve protocol design and reduce burden 03:50
• Designing trials around real-world patient needs, diversity and access 05:46
• The role of DCTs, digital tools and patient feedback in improving the trial experience 12:55
• Why patient centricity still struggles to stick in practice 21:10
• Balancing standardisation with meaningful flexibility in global trials 25:26

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.

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 side of eCOA implementation, including why paper still appears in study discussions, where hidden costs and data integrity risks come from, and how better planning can remove licensing, translations, submissions and device strategy from the critical path.

We cover:

• What eCOA means across ePRO, ClinRO, ObsRO and PerfO [01:20]
• How eCOA can support primary and secondary endpoints [03:46]
• Why eDiaries and remote patient monitoring are related, but not the same thing [04:34]
• The history of eCOA and the move from paper to digital [06:17]
• The real cost comparison between paper and digital data capture [07:48]
• “Parking lot syndrome” and why timestamps matter [09:33]
• BYOD vs provisioned devices, including patient preference and reimbursement [11:10]
• Sustainability considerations for study devices [15:43]
• Why eCOA implementation often goes wrong [17:37]
• Why licensing, translations and submissions can delay study start-up [18:10]
• China-specific implementation considerations [21:00]
• Accessibility, caregiver support and assisted completion [23:53]
• Why paper introduces more risk than many teams realise [25:35]

Ultimately, eCOA is not just a technology choice. It is an implementation, data quality and patient experience decision.

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 designed
• The real impact of Risk-Based Quality Management and focusing on what truly matters
• How Digital Health Technologies are now expected, not optional
• The growing role and responsibility of sites when using their own technology
• What participant centricity actually looks like beyond the buzzwords

We 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 deploy

DCT 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 ops
• Real-world AI wins that are genuinely moving the needle
• What your organisation must have in place to succeed
• The hard conversation: risks, ethics, and accountability

AI 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 efficiency

•

The hidden operational layer driving much of the burden

•

How data overload is affecting clinicians and study teams

It 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.