*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.*

Senior Project Manager Guido Rieger joins VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. to outline:

📋 𝗦𝘁𝗲𝗽𝘀 𝘁𝗼 𝗘𝘅𝗲𝗰𝘂𝘁𝗲 𝗮 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗧𝗿𝗶𝗮𝗹:

– Identifying key stakeholders

– Defining study endpoints and scope

– Budgeting and regulatory planning

🛠️ 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻:

– Study protocol development

– Regulatory submissions and ethics approvals

– Site and patient selection

🔍 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗡𝘂𝗮𝗻𝗰𝗲𝘀:

– Understanding local regulations

– Importance of local expertise

🚀 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀:

– Addressing patient recruitment issues

– Site selection and vendor coordination

– Risk management strategies

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