AI is transforming clinical research faster than regulations can keep up. Olivia Longacre has spent over a decade on the front lines of global clinical trials, and she's watching MedTech companies make a critical mistake: treating AI as a replacement for human intelligence rather than a tool that requires constant oversight. With over 20,000 startups now working on software as medical devices, the stakes have never been higher.
In this episode, Olivia breaks down the most promising AI applications in clinical research, from patient recruitment to centralized monitoring, and reveals the dangerous pitfalls that founders must avoid. She shares real stories of AI hallucinations that made it to publication, explains the crucial difference between data access and data rights, and discusses why the intersection of technology and regulatory expertise isn't quite there yet.
Timestamps:
[00:00:00] Introduction to Olivia Longacre and AI's impact on clinical research
[00:01:00] How AI is outpacing governance and regulatory frameworks
[00:02:25] The shift from onsite to centralized monitoring
[00:03:50] What centralized monitoring means for speed and cost
[00:05:30] The most promising AI applications for small companies
[00:07:40] Where companies get overly excited about AI
[00:08:35] The danger of "set it and forget it" thinking
[00:09:25] Real story of AI creating a non-existent medical term
[00:12:15] Why human intelligence plus AI is critical
[00:14:55] Building teams that blend technical and clinical expertise
[00:18:15] What founders should ask when evaluating AI tools
[00:19:10] Data privacy and the difference between access and rights
[00:22:40] The gray area of laboratory samples and patient consent
[00:26:20] Looking ahead: the future of clinical research
[00:30:00] Skills clinical research professionals need to stay relevant
[00:31:00] Rapid fire questions
Follow Melita and Olivia:
Connect with Melita:
LinkedIn: https://www.linkedin.com/in/melitaball
Website: https://www.mbcaconsulting.com/about-us
Connect with Olivia:
LinkedIn: https://www.linkedin.com/in/olivia-longacre/