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Webinar

Rethinking eSource for eCOA, EDC, and Beyond: Moving from Data Origin to Convergence

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60 Minutes
Rather than debating where a data point originated, the real issue is how data needs to effectively converge to become defensible and submission-ready.
 
“eSource” has grown to be one of the more confusing terms in clinical research. Regulators have tried offering some clarity, such as defining eCOA data as source only upon its first point of permanent storage and not on the device it’s initially captured on. Yet this continues to be a point of confusion in the industry. Between direct data entry, EHR integrations, and expanding eCOA platforms, sponsors are left managing disparate repositories that claim to be “the source,” resulting in heavy downstream cost to timelines and negatively impacting data confidence.
 
Medidata and Fierce are convening a panel of subject matter experts, including a clinical site representative, a sponsor, and a regulatory expert, to reframe the question.
 
Using eCOA-to-EDC data flow as the clearest example, the panel will show what changes once eSource and secondary source data sit in one record.
 
Key Takeaways
  • Clarify how “eSource” is actually defined across eCOA, EDC, and beyond and why that definition keeps blurring.
  • Discuss various approaches and tradeoffs to reconciling data to reduce risk and improve trial timelines.
  • Discover how the downstream value of a unified data foundation, from stronger risk-based monitoring to faster compliance and safety insights, can be achieved once all trial data converges in one place.

Speakers

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Paul O’Donohoe

Paul O’Donohoe is Senior Director, 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 around the implementation of industry, regulatory and scientific best practices in clinical trials using mobile health technologies. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and was previously the Industry Vice-Director of the C-Path ePRO Consortium. 

Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health (now Signant Health), an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience. 

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Sweta Pittala

Sweta Pittala is Vice President of Technology Portfolio Management at Velocity Clinical Research, where she leads Clinical Systems and Product Innovation across one of the industry’s largest fully integrated clinical site organizations. She is responsible for advancing the technology, data, and product capabilities that enable clinical trials to operate more efficiently, intelligently, and at scale.

With deep experience building and scaling enterprise platforms globally, Sweta brings a unique perspective at the intersection of technology, product strategy, and clinical operations. Her work is grounded in the realities of site execution and focused on connecting systems, data, and workflows to enable faster, more informed decision-making across the clinical trial lifecycle.

Sweta is particularly focused on the next evolution of clinical operations—leveraging AI, operational intelligence, agentic systems, and digital twin technologies to move the industry from reactive trial management toward more predictive, adaptive, and intelligent operating models. At the center of this work is a commitment to reducing operational burden, strengthening collaboration across sites, sponsors, and CROs, and ultimately making clinical research more accessible and patient-centric.

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Phil Coran

Phil Coran is a Sr. Director in Global Compliance and Strategy at Medidata. He has had numerous interactions with regulatory authorities including the US FDA and the EMA. Prior to joining Medidata, Phil was at Pfizer for 12 years in Medical Quality Assurance where he conducted dozens of GCP site audits (worldwide) and technology compliance audits. Phil is a Certified Privacy Professional (CIPP/US), a Fordham School of Law JD and University of Washington MBA. Phil is a member of the New York and California Bar and a frequent speaker on clinical trial related topics including GCP and emerging technologies and is on the steering committee of the eClinical Forum.

Register here!

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