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.