"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.
Voluntary Investigator Site Survey survey concluded with 528 responses.
This 13-page position paper on eSource (source data that has been captured by an electronic tool which is a replacement for paper) describes the regulatory environment for the ultimate benefit of all stakeholders involved in EDC.
The eClinical Forum has conducted a global survey of investigational site experiences and expectations with EDC. The survey covers: * Computer use and site facilities. * Current experience with EDC. * Satisfaction with EDC features. * Future expectations.
A survey was undertaken by the eClinical Forum to review the pharmaceutical industry’s experience to date with Electronic Data Capture (EDC) and to better understand future trends. The survey report incorporates the responses of 30 companies, and includes a mixture of EU and US ethical pharmaceutical and biotechnology companies representing 8 of the top 10, 12 of the top 20 and 18 of the top 40 by revenue.
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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023
The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.
eCF APAC Autumn Workshop 2024 Announced
Registration is open! Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:
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.