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 Raeth, 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. Raeth 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. Raeth holds a Ph.D. in Business Administration with a specialization in Management Information Systems. Since joining Palleos 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.
Selected Links from the Episode:
Connect with Philip Raeth
Company: Palleos Healthcare
Clinical Research Organization (CRO)
Phases of Clinical Research (I-IV)
Investigator-Initiated Studies (IIS)
Management Information Systems (MIS)
ICH GCP (Good Clinical Practice)
Clinical Data Interchange Science Consortium (CDISC)
Study Data Tabulation Model (SDTM)
DIA (Drug Information Association)
MDCG (Medical Device Coordination Group)
Request for Proposal (RFP) Process
Book: High Output Management (Andy Grove) (Amazon, Barnes & Noble)
Book: Extreme Ownership (Jocko Willink & Leif Babin) (Amazon, Barnes & Noble)
Show Notes
[0:19] [0:19] On CRO Leadership
- Why CRO leadership is a complicated business
- Dr. Raeth’s background and Palleos Healthcare’s footprint across Europe
[2:38] Welcome and framing the conversation from a European CRO perspective
[3:07] What Palleos Healthcare does
- Germany-based full-service CRO (Phase I–IV) with a Phase II–III focus
- Strength in Central and Eastern Europe; “sweet spot” includes medium-sized biotech sponsors
[4:25] Education + Early Career Curiosity
- Business Administration + Management Information Systems (MIS)
- Interest in how IT systems and organizational structures influence each other
[5:45] Entrepreneurial Experiments (Pre-CRO)
- Early e-commerce venture lessons (including logistics and customer behavior)
- Exploring early e-mobility ideas before the market was ready
[7:10] Entering Clinical Research
- Exposure to clinical research through family mentorship and early CRO insights
- Entering the industry through business development and learning trial operations on the job
[8:56] Business Development as an Entry Point
- Why structured thinking matters: translating sponsor needs into proposals
- Learning the different “languages” of business and clinical operations
[10:10] The Scientific + Human Side of Trials
- Early exposure to oncology and operational realities at sites
- Relationships and trust as a competitive advantage for CRO partnerships
[11:30] Expanding into Finance and Data Management
- Understanding budgets, profitability, and operational constraints
- Legacy systems and the challenge of modernizing data management infrastructure
[12:42] Transition into Leadership
- Building cross-functional perspective over time
- Joining the management board and taking on Managing Director responsibilities
[13:52] Academic vs. Industry Research: A Spectrum
- Academic research often shaped by investigator curiosity + publication goals
- Industry research shaped by timelines, budgets, and regulatory outcomes
[15:10] Academic Protocol Challenges
- Protocols can become overloaded with secondary endpoints and exploratory objectives
- Limited funding can lead to underpowered analyses and heavy operational burden
[16:45] Operational Impact of Complexity
- More data fields and procedures increase missing data risk and monitoring burden
- Larger site workload can reduce motivation and clarity on priorities
[18:05] Industry-Sponsored Research Priorities
- Time-to-market as a dominant driver
- Emphasis on primary endpoints, operational efficiency, and predictable execution
[19:10] Study Power + Endpoint Strategy
- Primary endpoints are typically powered; secondary endpoints are often exploratory
- Academic incentives increase the desire for multiple downstream analyses/publications
[20:55] Why Academics Publish: What’s the “Currency”?
- Kunal asks what researchers really gain from publishing
[21:46] Publications as Career Currency (German/European Context)
- Publications and citations drive academic advancement and visibility
- Publications also influence industry recognition and “KOL” positioning
[23:44] Are Protocols Becoming More (or Less) Complex?
- Kunal asks about trends in protocol complexity over the last 5–10 years
- Increased standardization (protocols/CSRs) improves consistency and clarity
- Added requirements (risk management focus on critical data/processes) increase complexity
[26:41] Are Template Standards Being Used in Real Life?
- Templates aren’t used “one-to-one,” but there’s a shift away from copy/paste to structured templates
- Growing need to write different reports for different stakeholders (e.g., patient-facing summaries)
[28:16] European Resources for Templates and Standards / BDMA + DIA and Other Standardization Groups
- Discussion of organizations providing templates and standards across trial domains
- BDMA (German CRO association) and the role of CRO-side standard templates
- DIA and standards such as eTMF guidance; CDISC/SDTM as shared data expectations
[29:58] EU Resources + MDCG Mention
- Kunal references EU-facing templates/guidance (including MDCG in the device context)
[31:04] The Triangle: Time, Budget, and Quality
- “No free lunch”: trials are constrained by timelines, limited budgets, and scope/quality demands
- Biotechs often need milestone-driven timelines for financing (e.g., first-patient-in)
- Sponsors may need alternatives to expensive/competitive Western Europe + US-only strategies
- Matching standard of care, patient availability, and cost to sponsor constraints
[34:34] CRO as a Strategy Partner (Not Just Execution) / Managing Director Reality Check
- CRO conversations should clarify what the sponsor truly needs to get to the “next step”
- Study design tradeoffs: classic designs vs. interim analysis/adaptive-style approaches
- Kunal transitions to what CRO leadership looks like day-to-day
[37:11] Balancing Profitability, Talent, and Innovation
- No “hard boundary” as a Managing Director: setting constraints and delegating effectively
- Navigating sponsor expectations, internal team capacity, and long-term business decisions
[42:30] Risk-Sharing Models With Sponsors / Why Risk Sharing Rarely Works (In Practice)
- Why risk-sharing sounds attractive but is hard to implement fairly
- Budgets are probabilistic, but contracts often demand a single number
- Risk-based budgeting is conceptually strong but difficult to operationalize between two parties
[45:36] External Variables + Change Orders
- Many trial variables are outside sponsor/CRO control; change management is inevitable
[46:02] Practical Reality: Manage Risks as They Materialize
- Agree on a reasonable initial budget; then address risks through structured change orders
[46:46] AI in CRO Operations: What’s Real vs. Hype?
- Kunal asks about how a CRO evaluates and implements AI tools
[47:11] AI Has Multiple Meanings
- Statistics/ML has been used for years in some teams
- Current wave focuses on LLMs and language-driven workflows
[51:10] LLM Use Cases: From Templates to Deliverables
- Using prompts + templates to draft monitoring plans, data management plans, SOP content
- Emphasis on QC and human review—powerful but still early
[51:39] LLMs Reduce Knowledge “Moats”
- Public-domain knowledge becomes more accessible across languages/geographies
- Need for controls to address hallucinations and verification requirements
[55:05] Learning AI Without a Formal Course
- Dr. Raeth’s approach: podcasts, active engagement, and direct conversations with practitioners
[1:03:00] Books That Shaped Leadership Thinking
- High Output Management (Andy Grove)
- Extreme Ownership (Jocko Willink & Leif Babin)
[1:08:53] Career/Leadership Takeaways
- Practical advice for leaders: clarity on constraints, strong delegation, and structured decision-making
[1:11:34] Where CROs Are Headed
- Increasing standardization + interoperability demands
- CROs evolving toward “technology broker” roles that manage site–patient–sponsor interfaces
[1:12:14] Closing + Where to Connect
Major Themes
- Incentives Drive Study Design: Academic vs. Industry Research
- CRO Leadership: Navigating the Triangle of Time, Budget, and Quality
- The Future CRO: Standardization, Technology Brokerage, and Practical AI
Selected Quotes
“Publications are currency.” – Dr. Philip Raeth
“There’s always the triangle between time, budget, and… the scope of quality.” – Dr. Philip Raeth
Audience Question
How do you see the future of sponsor and CRO relationships changing? What are some of your some of the successes or challenges you’ve had working with CROs?
