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Episode Description: CTP 069 Leading a Clinical Research Organization in the European Union with Dr. Philip Raeth Guest Description: Choosing the right Clinical Research Organization (CRO) can make or break a clinical trial – especially when navigating the complexity of studies conducted across the European Union (EU). In this episode of the Clinical Trial Podcast, Kunal Sampat talks with Dr. Philip Räth, Managing Director of Palleos Healthcare, to unpack what separates reliable, high-performing CROs from those that fall short. With nearly 15 years of experience in the medical product industry, Dr. Räth brings a clear perspective on sponsor expectations, site relationships, digital strategy, and the evolving role of AI in clinical research. Under his leadership, Palleos has supported more than 336 projects across 23 therapeutic areas, operating in 19 countries throughout Europe. Dr. Raith holds a PhD in Business Administration with a specialization in Management Information Systems. Since joining Paleos in 2011, he has held leadership roles across business development, finance, data management, and full-service clinical operations. His current interests include digitally driven trial strategies and how AI/LLMs will influence clinical research workflows. Resources Mentioned: Guest Name: Philip Raeth ( / philip-raeth-51911114 ) Guest Organization: Palleos (https://www.palleos.com) Clinical Trial Podcast Blogpost: (https://clinicaltrialpodcast.com/phil...) Podcast Links: Spotify: (https://open.spotify.com/episode/04Z8...) Apple Podcast: (https://podcasts.apple.com/us/podcast...) Pocket Cast: (https://pca.st/4tad68d0) Stay in Touch: Sign Up for Clinical Trial Podcast Newsletter (https://sampat.kit.com) Contact Us At [email protected] Connect with Kunal: ( / kunalsampat ) Full Show Notes (Timepoints): 0:00 Podcast Introduction 0:19 Episode Introduction + Guest Setup 2:38 Dr. Raith Joins the Podcast 3:07 What Paleos Healthcare Does 4:25 Education + Early Career Curiosity 5:45 Entrepreneurial Experiments (Pre-CRO) 7:10 Entering Clinical Research 8:56 Business Development as an Entry Point 10:10 The Scientific + Human Side of Trials 11:30 Expanding into Finance and Data Management 12:42 Transition into Leadership 13:52 Academic vs. Industry Research: A Spectrum 15:10 Academic Protocol Challenges 16:45 Operational Impact of Complexity 18:05 Industry-Sponsored Research Priorities 19:10 Study Power + Endpoint Strategy 20:55 Why Academics Publish: What’s the “Currency”? 21:46 Publications as Career Currency (German/European Context) 23:44 Are Protocols Becoming More (or Less) Complex? 26:41 Are Template Standards Being Used in Real Life? 28:16 European Resources for Templates and Standards / BDMA + DIA and Other Standardization Groups 29:58 EU Resources + MDCG Mention 31:04 The Triangle: Time, Budget, and Quality 34:34 CRO as a Strategy Partner (Not Just Execution) / Managing Director Reality Check 37:11 Balancing Profitability, Talent, and Innovation 42:30 Risk-Sharing Models With Sponsors / Why Risk Sharing Rarely Works (In Practice) 45:36 External Variables + Change Orders 46:02 Practical Reality: Manage Risks as They Materialize 46:46 AI in CRO Operations: What’s Real vs. Hype? 47:11 AI Has Multiple Meanings 51:10 LLM Use Cases: From Templates to Deliverables 51:39 LLMs Reduce Knowledge “Moats” 55:05 Learning AI Without a Formal Course 55:59 Favorite Resources 1:03:00 Books That Shaped Leadership Thinking 1:08:53 Career/Leadership Takeaways 1:11:34 Where CROs Are Headed 1:12:14 Closing + Where to Connect Editor’s Note: The content on this page is accurate as of the posting date; however, some of our partner offers may have expired. Opinions expressed here are the author's alone, not those of any healthcare or medical institution, medical product or service organization, academic institution, medical provider, or other entity. This content has not been reviewed, approved or otherwise endorsed by any of the entities included within the post.