Strategy for Global Pivotal Studies – 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.*

🔍 Strategy for Global Pivotal Studies 🌍

Ever wondered what it takes to ensure the success of your clinical trials on a global scale? Our latest video in the 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 dives deep into the best practices for pivotal studies.

Join VP of Global Regulatory Affairs Jaishankar Kutty, Ph.D., along with industry veterans Brandy Chittester, Noel Keegan, and Guido Rieger, as they share their insights on:

🧠 Clearly defining endpoints

⚖️ Calculating an accurate sample size

🔍 Selecting an appropriate control group

📊 Using valid statistical methods

🤝 Collaborating with an experienced MedTech CRO

🌐 Global Study Considerations:

• Regulatory requirements
• Data quality and integrity
• Site and patient selection
• Reimbursement strategies

🧩 Data-Specific Considerations:

• Race and ethnicity data
• Data privacy (HIPAA, GDPR)
• Local regulatory compliance

🔍 Compliance and Reimbursement:

• Ensuring compliance with global standards
• Strategies for successful reimbursement

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