LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.


ECF Teams and Projects

Regulatory Advisory Group (REG)

Regulatory Advisory Group (REG)

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.

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