Course Description

The success of a trial relies on the strong bond between trial operations and project management throughout the trial life cycle. It is important to develop a specific knowledge of the strengths, weaknesses, and pitfalls of assumed risks at inception in order to devise mitigation strategies throughout the implementation phase. Systematic assessment of risk factors and key performance indicators at the start-up phase can allow for more efficient execution of a clinical trial and ensure better accrual rates. Best practices to expedite the start-up phase will also be discussed.

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Learning Objectives

• Develop a sound business strategy for a more efficient study start-up
• Identify key performance indicators and risk factors contributing to start-up delays
• Perform cause-effect analysis of factors attributing to delays of start-up phase
• Implement mitigation strategies to avoid delays and allow for a successful trial launch

Who Should Attend

• Directors of Clinical Operations
• New Clinical or other Project Team Leaders who will be managing projects
• Clinical, Regulatory, Research and Development (R&D) Staff
• Physician Investigators
• Clinical Research Coordinators and Clinical Research Associates, Data Managers or others working in biomedical product development
• Regulatory Affairs
• Quality Control Professionals, Quality Assurance Specialists

Instructor

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

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