Episode 05 Unlocking the Power of Archiving with Sam Rolfe

Heart of the Trial

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Today we're diving into the fascinating world of clinical trial data management with none other than software expert Sam Rolfe. This episode is a rollercoaster ride through the complexities and innovations in managing the documents and data of clinical trials. Buckle up for an insightful and fun discussion!

In this episode, Sam shares his journey from a sports science degree to becoming a key player in the world of clinical trial data archiving. Discover how the evolution of technology has transformed the way we store and manage critical clinical data, ensuring it remains accessible and usable for decades. Sam and Suzanne discuss the importance of regulatory compliance, the risks of outdated storage methods, and the future of decentralized trials.

Having spent the last 12 years working with SaaS Solutions built for Biotech, Pharma and CROs – Sam has experience in software delivery (project management and implementation), pre-sales and full end-to-end sales of both individual applications and platform solutions. He is passionate about how 'true cloud' SaaS solutions help drive Life Sciences companies to bring drugs and devices to patients faster; with greater efficiency, safety and compliance, while reducing the overall cost of development.

Highlights include:

• Sam’s accidental entry into the industry and his passion for making a difference.
• The challenges and importance of archiving clinical trial data for the long term.
• Real-life stories about outdated storage methods, including CDs and DVDs, and the risks they pose.
• The impact of COVID-19 on clinical trials and the rise of decentralized trials.
• Why proper data management and system validation are crucial for the safety and efficacy of new drugs.

Sam also reveals some hilarious and eye-opening anecdotes, like the tale of a clinical trial participant using their dog to cheat step count data. This episode is packed with valuable insights, humor, and a genuine passion for improving patient outcomes through better data management.
So, grab your headphones and join us for a deep dive into the techy side of clinical trials. Whether you're an industry insider or just curious about the behind-the-scenes magic that brings new treatments to market, this episode has something for everyone.
✨ Episode Highlights:

• [0:01] Suzanne's intro and welcoming Sam Rolfe.
• [0:30] Sam's background and the importance of archiving clinical trial data.
• [4:00] The risks of outdated storage methods and the transition to electronic systems.
• [10:00] The impact of COVID-19 on clinical trials and the rise of decentralized trials.
• [14:00] Validation of systems and why it's critical for regulatory compliance.
• [20:00] Fun and unexpected stories from the world of clinical trials.
• [30:00] Sam’s advice for new biotech companies entering the clinical trial arena.
• [40:00] Suzanne and Sam wrap up with a discussion on the importance of communication in the industry.

📞 Connect with Sam:

• LinkedIn: https://www.linkedin.com/in/sam-rolfe
• Email: [e-mail]

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at [e-mail]

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!