Knowledge Center

There's a particular kind of energy at the World Vaccine Congress that's hard to describe unless you've been in it. Hundreds of scientists, executives, policymakers, pharma leaders, CRO teams, and site networks, all in one convention centre, all sitting with the same fundamental tension. We know how to make vaccines that save lives. So why does getting them to patients still take so long?

I spent three days in Washington this week as part of the Medable team. Washington in late March meant that the cherry blossoms were just past their peak but still stunning, and catching them along the Tidal Basin between sessions was one of those small, unexpected gifts that a busy conference week doesn't always make room for.

For the conference, I came in with a clear intention. I wanted to reconnect with partners I respect, listen more than I talk, and have honest conversations about where this industry is and where it needs to go. What I didn't fully anticipate was how much the week would reinforce something I already believed but needed reminding of.

The urgency is real. And it's shared.

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According to Gartner, a request for information, or a request for proposal, is defined as “both the process and documentation used in soliciting bids for potential business or IT solutions required by an enterprise or government agency. The RFI document typically outlines a statement of requirements (SOR) to be met by prospective respondents wishing to make a bid to deliver the required solutions. It might cover products and/or services to meet the given requirements.”

Yet, for anyone entering into a long-term business agreement, a well-written RFI can do so much more than just assess and collect vendor capabilities. 

For the last decade, Medable has been transforming the capabilities of organizations across clinical research using the latest in new technologies. In this time, we’ve learned the best RFIs are able to define what success looks like, create alignment on measurable outcomes, and establish accountability on roles and responsibilities well before a contract is ever signed. When done correctly, it becomes a decision-making framework that offers clear vision to both organizations.

Recently, Medable received two RFIs around eCOA from top pharmaceutical organizations. They stood out to us because they were structured around performance, not promises, a distinction that makes all the difference.

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eCOA’s time has come. The market is currently estimated to be worth $2.3 billion, with projections showing it reaching nearly $5 billion by 2030. Despite this, paper still plays a prominent role for some clinical trials today.  

At first glance, paper may seem simple and familiar, even economical. However, in today’s regulatory and operational environment, paper COAs are not a risk averse choice when held to the standards of what sponsors, CROs, and regulators are looking for trial data to prove.  

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How do you drive adoption in a complex women’s health study? See how ICON and Medable reached 85% eConsent uptake across 1,200+ participants with a smarter, site-first approach.

Discover how Medable’s AI-powered oncology platform simplifies complex cancer trials by integrating eCOA, ePRO, and eConsent solutions—reducing trial time, improving patient retention, and enhancing data quality for faster, more efficient research.

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Learn how Medable is powering a decade-long, global long-term follow-up (LTFU) obesity study, achieving an impressive 97% patient retention rate without using a traditional EDC system all while delivering a compliant, scalable, and cost-efficient solution.

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Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

Digital data capture has become essential to modern clinical research. Sponsors and research organizations increasingly rely on electronic outcome assessment tools to collect high quality patient data, reduce manual errors, and improve regulatory compliance.

Two terms appear frequently in this space: eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient Reported Outcome).

These terms are closely related. However, they are not interchangeable.

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Sometimes when teams deploy eCOA (electronic Clinical Outcome Assessment) in clinical trials, challenges can arise with operational planning, protocol design decisions, or workflow alignment. Below are some of the most common missteps observed across sponsors, CROs, and investigative sites.

1. Treating eCOA as a late-stage add-on

Many teams wait until protocol finalization or even after startup to plan eCOA implementation.

Why this causes problems

• Instrument licensing or translations may not be ready
• Build timelines get compressed
• Protocol schedules may not align with electronic workflows

Best practice
Plan eCOA during protocol design, especially when selecting instruments and defining visit schedules. 

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Electronic clinical outcome assessment (eCOA) systems have reshaped how patient-reported outcome measures are collected and managed in clinical trials. Clinical operations leaders are under more pressure than ever to ensure that the migration from legacy paper instruments to digital platforms not only improves trial efficiency but also preserves data integrity, supports regulatory acceptance, and enhances participant experience.

The transition from paper to electronic capture represents a paradigm shift toward more efficient, accessible, and reliable data collection. Done well, eCOA strengthens evidence generation while reducing burden for participants and sites alike. Done poorly, it risks measurement bias, loss of comparability, and regulatory challenges.

In this article, clinical operations leaders will find evidence-based best practices for migrating and implementing patient-reported measures as part of eCOA strategies. These recommendations are rooted in published industry guidance and emerging scientific consensus, and they reflect the evolving landscape of digital assessment technologies.

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