"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 "eCF Requirements" have been released to eCF Members Only. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH. This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document. This V2024 release builds upon the V2023.3 release with additional mappings to regulatory authority documents.
If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason, the most current version of this document is always released for eClinical Forum members only eCF Members can obtain a copy by sending an email to REG@eclinicalforum.org. We also have a public release of the V2023 (last year’s eCF Requirements). This is available to non-members and can be downloaded from our website: Downloads (eclinicalforum.org).
The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org
Non-members who would like more information on becoming a member, should look at Membership (eclinicalforum.org) and/or contact Info@eclinicalforum.org
NOT A MEMBER?
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 Spring 2025 Workshops Announced
We are pleased to announce our 2025 Spring Workshops.
These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.
April 29-May 1: King-of-Prussia, PA, USA (kindly hosted by CSL Behring)
May 13-15: Walton Oaks, Surrey, UK (kindly hosted by Pfizer)
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.