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.

1. Heike Schoen, CEO, Loomis International (LinkedIn)
2. 20+ years in clinical operations, global trial strategy, and vendor management
3. Bart Scheerder, Host
4. Authority in European clinical operations and outsourcing trends
5. David Jones, Head of Content, The PBC Group

Recorded live at COG Europe, Amsterdam.

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.

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

1. Hybrid CRO partnership models are becoming standard—sponsors should seek partners who can offer both full-service and functional...