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Archive: Managing Phase I Clinical Trials

August 12, 2019
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Course Description

Phase I clinical trials aim to determine the safety, tolerability and pharmacokinetics (PK) of a compound. This web seminar will explore the challenges of developing Phase 1 clinical study protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and complexity, especially in trials that involve early-phase drug metabolism, imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity while ensuring trial success will also be discussed.

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Learning Objectives

  • Understand the FDA requirements for Phase I clinical trials and review the different Phase I trial designs
  • Discuss challenges with early phase studies for Sponsors, Contract Research Organizations (CROs), third-party vendors and sites
  • Discuss how to optimize protocol design for a special population
  • Identify risks in early phase clinical trials and mitigation strategies
  • Address strategic planning and budgetary considerations for Phase I designs

Who Should Attend

  • Clinical Operations and Clinical Research Associates
  • Medical Affairs Specialists and Leaders
  • Project Managers/Team Leaders
  • New Clinical or other Project Team Leaders who will be managing projects
  • Physician Investigators and Coordinators
  • Regulatory Affairs Professionals
  • Quality Assurance/Control (QA/QC) Professionals

Instructor

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies

 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.