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.