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Tactics for Global Pivotal Studies โ€“ MedTech CRO: Clinical Trial Execution Series [Video]

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Clinical Trials

Tactics for Global Pivotal Studies โ€“ MedTech CRO: Clinical Trial Execution Series

๐ŸŒ Our educational video series on clinical trials continues today with ๐—ง๐—ฎ๐—ฐ๐˜๐—ถ๐—ฐ๐˜€ ๐—ณ๐—ผ๐—ฟ ๐—š๐—น๐—ผ๐—ฏ๐—ฎ๐—น ๐—ฃ๐—ถ๐˜ƒ๐—ผ๐˜๐—ฎ๐—น ๐—ฆ๐˜๐˜‚๐—ฑ๐—ถ๐—ฒ๐˜€.

Senior Project Manager Guido Rieger joins VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. to outline:

๐Ÿ“‹ ๐—ฆ๐˜๐—ฒ๐—ฝ๐˜€ ๐˜๐—ผ ๐—˜๐˜…๐—ฒ๐—ฐ๐˜‚๐˜๐—ฒ ๐—ฎ ๐—ฃ๐—ถ๐˜ƒ๐—ผ๐˜๐—ฎ๐—น ๐—ง๐—ฟ๐—ถ๐—ฎ๐—น:
โ€“ Identifying key stakeholders
โ€“ Defining study endpoints and scope
โ€“ Budgeting and regulatory planning

๐Ÿ› ๏ธ ๐—ฃ๐—น๐—ฎ๐—ป๐—ป๐—ถ๐—ป๐—ด ๐—ฎ๐—ป๐—ฑ ๐—˜๐˜…๐—ฒ๐—ฐ๐˜‚๐˜๐—ถ๐—ผ๐—ป:
โ€“ Study protocol development
โ€“ Regulatory submissions and ethics approvals
โ€“ Site and patient selection

๐Ÿ” ๐—ก๐—ฎ๐˜ƒ๐—ถ๐—ด๐—ฎ๐˜๐—ถ๐—ป๐—ด ๐—ฅ๐—ฒ๐—ด๐˜‚๐—น๐—ฎ๐˜๐—ผ๐—ฟ๐˜† ๐—ก๐˜‚๐—ฎ๐—ป๐—ฐ๐—ฒ๐˜€:
โ€“ Understanding local regulations
โ€“ Importance of local expertise

๐Ÿš€ ๐—–๐—ต๐—ฎ๐—น๐—น๐—ฒ๐—ป๐—ด๐—ฒ๐˜€ ๐—ฎ๐—ป๐—ฑ ๐—ฆ๐—ผ๐—น๐˜‚๐˜๐—ถ๐—ผ๐—ป๐˜€:
โ€“ Addressing patient recruitment issues
โ€“ Site selection and vendor coordination
โ€“ Risk management strategies

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please โ โ โ reach out to RQM+โ โ โ  if you need support with clinical trials.*

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