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Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series

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*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.*


Combination Device Clinical Trials: Strategy & Tactics


Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video.


Key topics covered:

  • Definition and examples of combination devices
  • Regulatory pathways in the US and EU
  • Product development challenges unique to combination products
  • Essential documentation for robust trial design
  • Critical considerations for successful trial execution


    • Highlights include:

    • The importance of cross-functional expertise in drug and device development
    • Crucial pre-trial steps: usability studies, risk analysis, and early stability testing
    • Strategies for overcoming common trial execution challenges
    • Real-world case study demonstrating the value of proactive testing


      • Whether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy.


      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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