The eClinical Forum REG Team has completed a significant update to the Members-Only 2023 release of the eCF Requirements for Electronic Data for Regulated Clinical Trials (commonly referred to as the “eCF Requirements”).  This updated release incorporates extensive review and mapping of the EMA Guideline for Computerised Systems and Electronic Data in Clinical Research. This document is invaluable in determining if electronic records and systems are appropriate for use in regulated clinical trials.

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eClinical Forum's Autumn Americas Workshop last week at Janssen in PA was terrific! It was so dynamic with participants from so many different eCF members companies presenting, discussing, networking and generally having a good time together. We had participants from Acadia, AiCure, Amgen, Astellas, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Clario, CSL Behring, Early Access Care, eClinical Solutions, GSK, J&J/Janssen, Medidata, Memorial Sloan Kettering, Merck & Co, Merck KGaA, Safira, and Uniphi. But, still we missed our members who could not attend ... Abbvie, Alexion, Ferring, Oracle, Novartis, Pfizer, Signant Health, and Veeva. I look forward to more collaborating over the winter and to be together in the Spring!

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. Veeva Systems, an eClinical Forum member company, will showcase their end-to-end solution for patients, sites, and sponsors. The eClinical Forum does not promote nor endorse any particular technology vendors.

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. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.

This is an in-person workshop. There will be networking/social events on both evenings.  Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.

The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.

A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.

Stakeholders across clinical development along with patient advocates and regulators are energized by the rapid progress the industry has made and the possibilities of technology to speed the overall clinical development process and more fully deliver on the promise of personalized medicines. But, as the volume, variety and velocity of data continues to change in research, so has the need for more modern scalable technology. Data proliferation along with dwindling resources has made it a top priority for clinical development teams to look to technology to improve cycle times and the overall experiences across clinical teams and functions.  This Technology Showcase will highlight eClinical Solution’s elluminate® Clinical Data Cloud, which provides a centralized location for all trial data, across all sources, creating scalable and unified architecture for seamless data flows and an interoperable ecosystem of tools and capabilities.

This is the ONE FILE that you need to perform an eSRA Assessment. This 2023.2 version has a correction as the previous version incorrectly had two question 26. (July 1, 2023)

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2023)