Description
Is your Clinical Study Protocol robust enough to ensure success? Join us for an insightful webinar where industry leaders discuss the essential elements and challenges of developing a Clinical Investigation Protocol. A well-designed protocol generates critical clinical data to support investigational device claims, demonstrate safety and effectiveness for regulatory submission, engage in reimbursement discussions, and more. To achieve this, your Clinical Study Protocol must align with business objectives and clearly outline operational details for efficient execution. Understanding stakeholder needs, fundamental clinical trial design, and effective project execution are key to success.
In this webinar, NAMSA experts will leverage their combined 50+ years of experience in protocol design and execution, providing insights to help prevent common pitfalls. Don’t miss this opportunity to gain valuable insights from industry experts and enhance your clinical study protocols. Register now to secure your spot!
Key Takeaways:
- Identify key stakeholders and relevant content of a clinical protocol
- Identify risks in protocol development and best practice mitigations
- Case examples of de-risking protocols for optimal outcomes data and efficient study execution
Speakers
Wendy Schroeder, BSN, CCRC/PM, CRCP
Principal Strategy Consultant, Clinical
Wendy has been involved with research and clinical trials for more than 25 years. She has clinical trial execution experience and as a NAMSA consultant supports medical device product development including clinical strategy interactions with the FDA. Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.
Director, Global Strategy Services
A recognized expert within the medical device industry, Chris is highly skilled in biostatistics, scientific communications and regulatory meetings. Chris is experienced with an array of different technologies and therapeutic/diagnostic areas, including cardiovascular disease, gastroenterology, neuromodulation, neurology, oncology, ophthalmology, orthopedics, pain medicine, respiratory/sleep medicine and urology. He has participated in over 200 FDA meetings, including more than 25 FDA Advisory Committee (Panel) meetings. Chris has also helped dozens of global manufacturers understand and translate complex ideas and data into simple and convincing concepts, leading to successful regulatory, scientific and business outcomes. He has been instrumental in bringing many novel products to market.
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This is a free educational webinar.
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