Key Aspects of Medical Device Clinical Trial Design (1/2) – MedTech CRO: Strategy Development 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.*

✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮)

Cari Kniola, Guido Rieger, and Jaishankar Kutty, Ph.D. return for our educational clinical trial series, this time joined by Senior Manager of Biostatistics, Rolf Hövelmann.

This video covers...

𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 𝗙𝗮𝗰𝘁𝗼𝗿𝘀:

– Addressing and mitigating confounding factors, biases, and variations

– Ensuring treatment effects can be isolated

𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:

– The importance of considering end goals for product and study

– Incorporating clinical expertise from the start

𝗦𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝗮𝗹 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:

– Effective trial design from a biostatistics perspective

– Traditional vs. adaptive trial designs

𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀:

– Balancing regulatory, reimbursement, and practical clinical needs

– Ensuring feasibility and practicality in trial execution

Look for the second video about trial design next week!

Reminder that you can find all of our clinical trial videos in other places, too. 👇

💼 LinkedIn

📺 The RQM+ YouTube channel

📧 For support with clinical trials, please contact us directly.

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