Despite two decades of technological advancement, the debate between paper and electronic clinical outcome assessments (eCOA) remains surprisingly unresolved, even with the available evidence. This webinar revisits the foundational assumptions that have shaped data collection strategies in clinical research and asks whether current practice reflects the state of the science or the weight of institutional habit.
The early promise of eCOA was well-founded. Electronic instruments offered real-time data capture, reduced transcription error and improved compliance monitoring and auditability. Yet adoption has been uneven, and resistance has persisted, often anchored to concerns that were legitimate in 2005 but have since been substantially addressed. This session examines the gap between perception and current capability.
Paper is often framed as the “gold standard” for outcome assessment, but this assumption warrants scrutiny. Paper-based patient-reported outcome data can be incomplete, error-prone and difficult to verify, with challenges such as illegible entries, missing data and protocol deviations identified late in the study. While electronic instruments are held to rigorous validation standards, paper-based methods have not faced the same level of scrutiny.
However, this session will also identify specific contexts in which paper remains a capable, defensible and at times preferable modality, including rare disease studies, small patient cohorts and populations with genuine device-use barriers, and instruments of limited complexity.
On the technology side, the session surveys the distance travelled since the early days of provisioned handheld devices. Build timelines, translation workflows and screenshot review processes have all been substantially transformed. The emergence of agentic AI has further accelerated eCOA development and deployment, reducing the manual burden that once made electronic implementation a significant operational undertaking.
Attendees will leave with an evidence-informed framework for modality selection, grounded in current capabilities rather than assumptions formed when the field was still calibrating to a new paradigm.
Register for this webinar to learn how eCOA in clinical research can improve data quality, strengthen compliance monitoring and support evidence-informed modality selection.
Speakers
Dawn Jordan, Associate Director, COA Oversight & Linguistic Validation, Takeda
Dawn Jordan is Associate Director, COA Oversight & Linguistic Validation at Takeda, where she’s built a team supporting the delivery of high-quality clinical outcome assessment content across clinical research programs. She brings nearly 20 years of experience in scientific and medical translation, with expertise spanning both sponsor and vendor perspectives. Her COA experience encompasses the full spectrum, from paper COA development through eCOA implementation.
Before joining Takeda, Dawn led the Scale Management team at WCG Clinical, overseeing paper COA development, linguistic validation, and the electronic implementation of translations. She previously served as Head of the Translation Department at Ubiqus USA, where she led a cross-national team of project managers supporting a broad range of translation initiatives, from medical devices to media and entertainment.
Dawn also brings a strong academic background to her work, having served as a Lectrice at INSA Lyon and as an adjunct instructor at NYU’s School of Continuing and Professional Studies. Her career reflects a deep commitment to language quality, cross-cultural communication, and the integrity of translated materials in scientific and educational settings.
Message Presenter
Paul O’Donohoe, Director, eCOA Product and Science, Medidata Solutions
Paul O’Donohoe is currently a Senior Director of eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata’s electronic clinical outcome assessment technologies and supporting internal teams and partners in implementing industry, regulatory and scientific best practices in clinical trials using mobile health technologies. Paul is passionate about advancing the field of eCOA and mobile health through research and active involvement in industry consortia. He previously served as Industry Vice-Director of the C-Path ePRO Consortium. Earlier in his career, Paul worked as a Research Psychologist at a child and adolescent mental health clinic in Dublin, Ireland. He later moved into the health consulting field with United BioSource Corporation, where he worked across health outcomes, health economics and health data capture groups. Prior to joining Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led the health outcomes team. He holds an MSc in Cognitive and Clinical Neuroscience.
Message Presenter
Mark Wade, Global Practice Leader & COA SME, TransPerfect Life Sciences
Mark P. Wade is the Global Practice Leader at TransPerfect Life Sciences, the largest language translation company globally, where he serves as the resident SME for all patient-facing clinical trial processes and translation. Mr. Wade has 20 years of experience in life sciences, including serving as International Regional Director for EMEA at Ethicon and Ethicon Endo-Surgery, a Johnson & Johnson company (NYSE: JNJ). For nearly 10 years, Mr. Wade served as Global Practice Leader at another global language translation company. He is a published expert in electronic clinical outcome assessments (eCOA), including two eBooks, as well as clinical services, patient recruitment and site selection. He has also authored clinical posters and numerous articles in trade journals. Mr. Wade has chaired sessions, presented and published posters at ISPOR and ISOQOL annual symposia, as well as numerous other internationally recognized conferences. He is a past industry Co-Director and an active Committee Member of the C-Path eCOA Consortium, the ISOQOL Translation & Cultural Adaptation (TCA) Special Interest Group (SIG) and the ISPOR Digital Health (DH) SIG.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Operations Leads and Study Managers involved in data collection strategy
- Data Managers and eCOA/ePRO Specialists navigating modality decisions across therapeutic areas
- Sponsors evaluating electronic data collection options across study types
- PCORI Scientists
- Health Services Researchers
What You Will Learn
Attendees will gain insight into:
- Why paper’s “gold standard” status reflects institutional inertia, not empirical evidence; paper has never been held to the same validation rigor as electronic instruments
- The most common objections to eCOA (device reliability, build complexity and translation burden) were valid in the early adoption period but no longer reflect current platform capabilities
- Why modality selection should be driven by study-specific parameters (site infrastructure, patient population and instrument complexity), not organizational default
- How agentic AI has materially compressed eCOA build and translation timelines, removing many of the operational barriers that made electronic implementation a significant resource commitment
Xtalks Partner
TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. For more information, please visit our website at https://lifesciences.
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