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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.
There has been a request from our members to develop a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations. This would be similar to what we already offer (for free) to sites around the globe to evaluate their EHR systems or other systems that originate data that may become part of a clinical trial (this questionnaire is called “eSRA” for “e-Source Readiness Assessment” and can be found on our website at eSRA (eclinicalforum.org)). The team is under the guidance of the eCF REG team, which produces the “eCF Requirements” that the eSRA and ISF assessments are based on. A Pilot of the eISF Assessment Questionnaire and Handbook was run in 2023. We anticipate a public/free release of this product in early 2024. For more information or to become involved in this team, members should send an email to ISFA@eclinicalforum.org.
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eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
(09/01/2025)
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.
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 Webinar: Audit Trail Review – Is your Audit Trail fit for purpose?
Date: Thursday, February 20, 2025 Duration: One hour
Presenter: Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)
Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.