Web Seminar Recordings on Key Clinical Research Topics
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Archive: Managing Phase I Clinical Trials
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.
Video Preview
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.
