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Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series
Manage episode 422871011 series 2688337
*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.
--
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
166 episodes
Manage episode 422871011 series 2688337
*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.
--
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
166 episodes
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