Checkout 0
Training Courses - Web Seminar Archives

Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.

Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).

Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.

Archive: Managing Phase I Clinical Trials

Course #: BI16052
April 4, 2024

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


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.