What I've Learned About Global eCOA Deployment Challenges To Help Biotech Sponsors

Author: Keli Platco

I've spent more than 20 years working in clinical research, helping sponsors design and launch studies that leverage electronic Clinical Outcome Assessments (eCOA). Over that time I've seen the technology evolve from relatively simple electronic diaries into sophisticated global platforms capable of supporting complex protocols, diverse patient populations, and increasingly demanding data collection requirements.

I've also experienced many of the challenges that come with deploying eCOA across global trials. Some challenges have become easier to solve as technology has advanced. Others continue to surface, even with the best platforms and most experienced study teams.

I've learned that successful eCOA deployment comes down to getting just a few fundamental things right. And the good news is that we have more tools, capabilities, and experience available today than ever before to address these challenges.

The Biggest Mistake Sponsors Make

When planning a study, sponsors often focus on whether technology can support the protocol. Too often, sponsors ask, "Can the technology do this?" when the more important question is, "Should we be asking participants and sites to do this in the first place?"

Technology can enable a study. It cannot overcome a poorly designed participant experience.

The more important question is whether the protocol can realistically be executed by sites and participants.

By the time an eCOA partner is selected, decisions around assessment frequency, questionnaire length, diary schedules, visit cadence, and the overall schedule of events have often already been finalized. Those decisions have a far greater impact on participant engagement than any individual technology feature.

I've seen studies with highly sophisticated technology struggle because participation became too burdensome. I've also seen studies with relatively straightforward technology perform exceptionally well because the participant experience was thoughtfully designed from the beginning.

Technology can enable a study. It cannot overcome a poorly designed participant experience.

Participants Experience the Study, Not the Technology

One of the most positive changes I've seen in recent years is the increased focus on participant-centric study design.

Participants don't think about eCOA, eConsent, telemedicine, wearables, or any other technology as separate components. They experience the study as a whole.

Every assessment they complete, every reminder they receive, every site interaction, and every support request contributes to their overall experience.

When participation feels manageable, engagement tends to follow. When participation becomes confusing or burdensome, compliance often suffers regardless of how advanced the technology may be.

Before asking whether technology can collect the required data, sponsors should first ask whether participants can realistically provide it.

Technology Burden Is Real

As more digital solutions are introduced into clinical trials, sites and participants are increasingly expected to navigate multiple systems at the same time.

One of the most common concerns I hear from sites isn't about a specific platform. It's about the cumulative burden created by managing several technologies simultaneously.

Individually each solution may make sense. Collectively, they can create friction for both sites and participants.

Sponsors routinely assess protocol burden. They should apply the same level of scrutiny to technology burden.

A study's success is often influenced not by the quality of any single system, but by how easily all systems work together within the participant and site experience.

Every Data Point Has a Cost

Clinical teams are naturally focused on collecting the data needed to answer important scientific questions. However, every additional assessment, diary entry, questionnaire, or workflow introduces additional burden.

The question should not be whether data can be collected.

The question should be whether the value of the data justifies the effort required to collect it.

The highest-performing studies are rarely the ones collecting the most data. They're the studies that are deliberate about collecting the right data while minimizing unnecessary burden on participants and sites.

That balance is often established during protocol design, long before technology discussions begin.

Look Beyond Compliance Metrics

Many sponsors view compliance as the primary measure of eCOA success.

Compliance matters, but it is usually the result of earlier decisions.

Most studies show warning signs before compliance declines. Onboarding challenges, increased support requests, incomplete assessments, participant feedback, and site feedback often provide early indicators that something is not working.

The sponsors that consistently execute well focus on identifying and addressing these signals early rather than waiting for compliance reports to reveal a problem.

By the time compliance drops, the root cause often started much earlier.

Questions Sponsors Should Ask Before Selecting an eCOA Vendor

Before evaluating technology solutions, I encourage sponsors to take a step back and challenge a few assumptions:

Study Design

• Can participants realistically do what we're asking them to do?
• Does every assessment provide meaningful value?
• Have we minimized unnecessary participant and site burden?

Participant Experience

• What will participation actually feel like for the patient?
• Have we identified likely points of friction before launch?

Technology Strategy

• How many systems, logins, and workflows will sites and participants need to manage?
• Are we simplifying the experience or adding complexity?

Execution

• Can sites realistically execute the protocol as designed?
• Are we monitoring early warning signs, not just compliance metrics?

The Most Important Question

• If I were the participant, would I willingly complete this study as designed?

I've often found that the answers to these questions have a greater impact on study success than the technology selection itself, and have made these available for you to use in the PDF below.

My Final Thoughts

The most successful eCOA deployments I've been involved with haven't necessarily been the simplest studies. They've been the ones where teams anticipated challenges early, made deliberate choices about technology and workflows, and stayed focused on the needs of participants and sites.

I believe the biggest opportunity isn't just to deploy more advanced technology. It's to use that technology strategically. That means involving the right expertise earlier, designing more manageable participant experiences, connecting systems effectively, using data to make proactive decisions, and choosing platforms that can evolve with the study.

My biggest lesson after 20+ years? Successful global eCOA deployment isn't about choosing between good study design and good technology. It's about bringing the two together, supported by the right people and processes, to make clinical research work better for everyone involved.

And I enjoy discussing these approaches, it's why done this for so long. If you have any questions and want to discuss further, feel free to request some time below.