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Project Management of Clinical TrailsPlanning & practical aspects of clinical projects
Efficiently overseeing a clinical trial has the potential to expedite product approval, resulting in a quicker market entry. This course offers the fundamental aspects of planning and managing clinical trial projects, covering the development of trial objectives, formulation of plans and timelines, allocation of staff and budgets, site selection, and engagement with various stakeholders including physicians and regulatory bodies. Using...Continue reading
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Issues to be covered
Project Management means overseeing all aspects of the trail life cycle.
- Product life cycle and the importance of clinical trials
- Sponsored vs. independent studies.
- Basic of good clinical practice – GCP
- Planning and designing a clinical trial
- Key considerations in protocol objectives and various study designs
- Project stakeholders
- Protocol development
- Budget timelines and resources
- Clinical Trial conduct
- Site selection, monitoring and Patient enrolment
- Data management Adverse event reporting
- Communication with internal and external personnel
- Overview of regulatory requirement – how to prepare for an audit (US and EU)
- Closeout activities
- Clinical study report
- Manuscript preparation
Who should attend
- Clinical Project Managers
- Clinical Research Associates – CRAs
- Clinical/Medical Research Scientists
- Research Nurses/coordinators
Benefits to the Participants
- Skill Enhancement: Participants are acquiring a comprehensive understanding of the key principles and practices in clinical research and trial management. Attendees acquire new skills and enhance existing ones, making them more effective in their roles.
- Career Advancement: The course enhances professional development and hence career advancement opportunities
- Effective Protocol Design: The course equips participants with the knowledge to develop well-structured protocols, leading to more successful and scientifically sound studies.
- Efficient Trial Conduct: Learn best practices for site selection, patient enrollment, and monitoring during the trial and by that an efficient conduct of clinical trials.
- Preparation for audit- Covering the essentials of regulatory compliance, helping participants be prepared for inspections.
About The Lecturer
