Executive Development Programme in Trial Planning
-- ViewingNowThe Executive Development Programme in Trial Planning is a certificate course designed to provide learners with essential skills in trial planning and execution. This program emphasizes the importance of effective trial planning in the pharmaceutical and clinical research industries, where successful trials can lead to life-changing treatments and industry breakthroughs.
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โข Trial Planning Fundamentals: Overview of trial planning, setting trial objectives, and identifying key stakeholders.
โข Regulatory Compliance: Understanding regulatory requirements for clinical trials, including FDA and EMA guidelines.
โข Protocol Development: Designing a trial protocol, including eligibility criteria, endpoints, and data management plans.
โข Site Selection and Management: Identifying and selecting trial sites, negotiating contracts, and managing site relationships.
โข Budgeting and Resource Allocation: Developing a budget, identifying resources needed, and managing costs.
โข Project Management: Overview of project management principles, including risk management, timeline development, and resource allocation.
โข Data Management and Analysis: Collecting, managing, and analyzing trial data, including data quality control and statistical analysis plans.
โข Stakeholder Communication: Communicating with trial stakeholders, including regulatory agencies, ethics committees, and investigators.
โข Quality Assurance and Quality Control: Implementing quality assurance and quality control measures to ensure trial integrity.
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