Clinical Trial Management Resources

21 CFR Part 11

21CFRPart11.com provides access to information on the rule, and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators. On this site, you will find the latest conference, meeting and seminar information, as well as links to vendors and consultants who can help the pharmaceutical community manage issues of clinical trial process compliance with regulations and productivity.

We encourage the community to help us broaden the knowledgebase by contributing articles, presentations and best practices for running trials regarding 21 CFR Part 11 and its impact on the GxP environment. We value your input on this site and also welcome any comments or suggestions.

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Medical Imaging and Drug Development

Learn more about the FDA’s “Critical Path” initiative to develop new imaging agents and evolve the use of medical imaging during the product development stage of the clinical trial process in an effort to contribute to the advancement of therapies to treat disease.

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Division of Medical Imaging and Hematology Products (DMIHP)

Learn more about FDA regulations for small molecule agents and biologics used in medical imaging and hematology, and how it can affect your clinical trial management process.

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