Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series скачать в хорошем качестве

Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series

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. ❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations and site selection effectively? 🎬 The second video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟮/𝟮) answers these questions. Once again, ⁠Jaishankar Kutty, Ph.D.⁠ is back with VP of Strategic Regulatory Affairs ⁠Sew-Wah Tay⁠. 𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻: 📌 The importance of CGMP principles and full traceability for FIH devices 📌 Managing device iterations in a 10-15 patient FIH study 📌 Key considerations for site and physician selection across different geographies We hope these strategies help you navigate the complexities of FIH studies and ensure success. ⁠RQM+⁠ is here to help if you need it.