"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites). For draft documents, comments are submitted to regulatory authorities. Final documents are mapped to the "eCF Requirements" which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from these regulatory authorities, and boils them down into 37 unique statements. This is updated annually and released to eCF members. Previous year's "eCF Reqs" are released to the public.The eCF Requirements can be used to determine if systems that handle data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features. Each eCF member company may have one representative on the REG team.
NOT A MEMBER?
Japanese translation of Inv Site File Assessment
Version 2024JP1 (25-Nov-2024)
Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”
This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.
Webinar: eClinical Forum Membership Overview
The eClinical Forum is “For the members and by the members” and we want to be sure that we are providing our members with the best possible support for what they do. This webinar is targetted to our "primary representatives" from each eCF member organization, however anyone interested in understanding an overview of the eClinical Forum is welcome to attend. eClinical Forum membership is per company (not individual) and participation in eCF online events, project teams, and members-only publications are available to each person in a member organization without any additional cost.
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.
eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping
eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.
The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.