Navigating Global Clinical Trial Outsourcing: Risk, Strategy & CRO Partnerships in a Changing World

Gain operational clarity on the evolving landscape of clinical trial outsourcing—discover the risk factors, partnership models, and geographic strategies reshaping CRO selection and clinical operations.

Guest

Heike Schoen, CEO, Loomis International (LinkedIn)
20+ years in clinical operations, global trial strategy, and vendor management
Bart Scheerder, Host
Authority in European clinical operations and outsourcing trends
David Jones, Head of Content, The PBC Group

Recorded live at COG Europe, Amsterdam.

Episode Overview

This episode of The COG Review: Building Better Clinical Studies features Heike Schoen, CEO of Loomis International, in a keynote session from COG Europe. The discussion centers on the global shift in clinical trial outsourcing, with a sharp focus on how sponsors and CROs are adapting to rapid changes in regulation, geopolitics, and technological innovation.

Heike Schoen explores the evolution of sponsor–CRO partnerships, from transactional service agreements to nuanced hybrid models, where flexibility and deep therapeutic expertise are essential for success. Practical examples from Novartis–PPD and Moderna–Medidata illustrate both functional service partnerships and the impact of digital, decentralized trials.

Key areas include CRO selection strategies for emerging markets, navigating regulatory changes, and building operational agility in the face of supply chain fragility and geopolitical risk. Insights are tailored for professionals involved in clinical operations best practices, outsourcing decisions, and those seeking to optimize clinical studies through smarter partnerships and technology use.

The session closes with real-world challenges and live audience questions on how to structure outsourcing models, respond to regulatory shifts, and future-proof location choices for clinical trials.

Key Moments

00:03:37 – Global clinical trial outsourcing market growth and drivers

00:04:45 – The rise of hybrid CRO partnerships: strategic alliances vs. modular models

00:06:06 – Digital platforms and AI: boosting operational efficiency in decentralized trials

00:07:00 – CROs must demonstrate deep therapeutic expertise and flexible service models

00:08:15 – Geographic diversification: assessing emerging markets for clinical study optimization

00:10:06 – AI’s impact on CRO value pools: standardization and resource allocation

00:12:09 – Comparative advantages of clinical outsourcing in the US, Asia-Pacific, Europe, Latin America, Africa, and the Middle East

00:14:24 – Geopolitical risks in outsourcing: contingency planning for disruption and instability

00:16:08 – Supply chain fragility and cross-border data management: lessons for clinical operations best practices

00:18:10 – Key drivers for outsourcing strategy: cost pressure, patient diversity, regulatory speed

00:19:49 – Location strategy essentials and what sponsors should expect from CROs

00:24:29 – Guidance for small biotechs on engaging CROs and designing flexible outsourcing models

Top 3 Takeaways

Hybrid CRO partnership models are becoming standard—sponsors should seek partners who can offer both full-service and functional capabilities to improve flexibility and execution speed.
Geopolitical risk mitigation and supply chain planning are now core to clinical trial outsourcing decisions; build contingency plans and select CROs with multi-jurisdictional expertise.
Digital technology and real-time data analytics are advancing clinical study optimization; prioritize CRO selection processes that assess digital readiness and regulatory adaptability.

Links & Resources

Quotes

“CROs are no longer simply generalists—they’re expected to offer deep therapeutic specialization and the agility to scale services as sponsors’ needs change.” — Heike Schoen

“Location strategy matters more than ever before. Regulatory and political stability are now core criteria in both site and CRO selection.” — Heike Schoen

“The shift to hybrid outsourcing models allows sponsors to retain expertise in-house while leveraging CRO resources for specialized functions, giving teams more flexibility to manage complex trials.” — Heike Schoen

“The impact of AI on CROs will disrupt up to 30% of traditional value pools, from monitoring to medical writing, driving efficiency but requiring teams to rethink resource allocation.” — Heike Schoen

“Contingency planning for geographic disruption isn’t optional anymore—it’s essential for every sponsor managing clinical trial outsourcing in a volatile world.” — Heike Schoen

-----------

Further content and agendas: hhttps://thepbcgroup.com