Description:

In this episode, we discuss how to select a site for a Clinical Trial.

Joining us for the conversation is Isabella Schmitt, MBA, RAC, the Vice President of Life Science Solutions at Proxima Clinical Research. Isabella brings a wealth of knowledge and experience in the intricacies of clinical study site selection, shedding light on the critical role it plays in MedTech product development.

In addition, we're joined by Samantha Pickett, an Associate Director at Proxima Clinical Research. Samantha dives deep into the key considerations for site selection, emphasizing the significance of patient demographics, regulatory compliance, and technological access.

This was a fun conversation as we discussed how to navigate the complexities of regulatory landscapes, explore collaboration strategies, share best practices, and draw insights from real-world case studies.

Some of the highlights of this episode include:

1. Why Site Selection Matters:

• In the realm of MedTech product development, site selection is the linchpin. It can make or break the trajectory of your innovation.
• Selecting the right geographic location and clinical trial site sets the stage for successful outcomes and paves the way for future success.

2. Key Considerations for Site Selection:

• Let's dig into the key considerations when selecting a site for your clinical study. Patient demographics, regulatory environment, and investigator expertise are vital factors.
• Infrastructure, access to cutting-edge technology, and the patient population at the site are equally critical aspects to consider.

3. Navigating Regulatory Landscape:

• Regulatory challenges can be formidable obstacles in the site selection process. We'll explore the complexities and implications these challenges can have.
• Tune in to learn about strategies that can help you navigate these hurdles, ensuring compliance and successful site selection.

4. Collaboration and Partnerships:

• Collaborating with research institutions, hospitals, and academic centers can be a game-changer. We'll discuss the numerous benefits this collaboration can bring to your site selection process.
• Moreover, we'll provide insights into strategies for establishing fruitful partnerships that enhance your site selection efforts.

5. Best Practices and Case Studies:

• Let's delve into real-world examples from the MedTech industry. We'll share success stories and case studies that illuminate the art and science of site selection.
• By extracting actionable insights and best practices from these examples, we aim to empower you in your own site selection endeavors.

Quote:

"Your aim should be to ensure everything aligns with expectations. The IRB's primary focus is patient protection, ensuring they comprehend the trial's details, risks, and benefits while safeguarding their privacy." ~Samantha Pickett

Reference Links:

• Samantha Pickett
• Isabella Schmidt
• GG Academy
• Greenlight Guru
• Etienne Nichols LinkedIn

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