Tactics for First-in-Human Studies – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

*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 ⁠⁠reach out to RQM+⁠⁠ if you need support with clinical trials.*

❓ How do you effectively 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 first-in-human clinical studies?

❓ What 𝘁𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗲𝗽𝘀 ensure success?After our first two strategic videos, our educational video series on clinical trials continues with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀.

Frank Maier, Director of Project Management within RQM+ Clinical Trial Services, joins Jaishankar Kutty, Ph.D. to walkthrough tactical specifics of first-in-human (FIH) clinical investigations.

𝗪𝗮𝘁𝗰𝗵 𝗮𝗻𝗱 𝗹𝗲𝗮𝗿𝗻:

➡️ The steps for executing successful FIH studies

➡️ Key roles and responsibilities for sponsors and CROs

➡️ Importance of local expertise and compliance with changing regulations

➡️ Managing safety reporting and risk documentation

➡️ Strategic considerations for geographical site selection

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