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Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
Authors: Jules Mitchel, PhD, is the Co-Founder of Target Health, US. Yumi Sugiura is the Associate Director of Global Data Management & Centralized Monitoring for Bristol Myers Squibb, Japan. Valdo Arnera, MD, is a Scientific Advisor for ERT, Switzerland. Greg Gogates is the Vice President of Quality/Regulatory for Fasor, US. Alan Yeomans is a Quality Manager for Viedoc Technologies, Sweden. Devry Spreitzer is a Senior Director, Data Integrity Quality Assurance for Astellas Pharma Global Development, US. Suzanne Bishop is the Americas Administrator for eClinical Forum.
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(04/11/2025 - 06/11/2025)
(04/11/2025 13:00 - 06/11/2025 15:00)
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here
Technology Showcase: eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. READ MORE for details on this Technology Showcase.