Geographic Considerations in International Clinical Trials

This practice note discusses drug, medical device, and biologics clinical trials conducted outside the United States. Among the topics addressed are data use, export control, and clinical trial approval and conduct rules.  

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• Clinical Trial Agreement Key Considerations Checklist
  Identify key legal and business considerations to consider when evaluating clinical trial agreements. 

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• Clinical Research Support Agreement
  Use this template clinical research support agreement as a starting point for negotiating and drafting an agreement between a drug manufacturer (sponsor) and an institution taking on responsibility for conducting clinical research.

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