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Author Archives: Patrick Marquis

Clinical outcome assessment qualification program

The FDA has released a road map to patient-focused outcome measurement in clinical trials. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm For questions and implementation please contact patrick.marquis@twolegs-consulting.com

November 10, 2013 in Regulatory News.

FDA News

FDA latest thinking on Clinical Outcomes Assessment Qualification Program: FDA released a new roadmap to patient-focused outcome measurement.

October 17, 2013 in Regulatory News.
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