EUCROF has been featured in European Biotechnology Magazine, in an in-depth article on how Europe is rethinking the relationship between CROs and CDMOs. The piece presents EUCROF’s position on the developments shaping the European clinical research landscape.
We are pleased to share that EUCROF’s perspective is featured in “Europe rethinks the CRO-CDMO model”, written by Victor Kotsev and published by European Biotechnology Magazine on 2 November 2026.
This contribution gives EUCROF the opportunity to share its views with the wider biotechnology and life sciences community. It highlights the importance of clinical research and the role of Contract Research Organisations in strengthening Europe’s research ecosystem.
What the article is about
Should a biotech company entrust its molecule to a single integrated partner, or build a network of specialised providers around it? Manufacturers and clinical service providers are moving in both directions at the same time, through acquisitions, alliances, spin-outs and portfolio refocusing.
The article’s central message is that outsourcing is not the problem. The problem is that regulatory responsibility can never be outsourced. Sponsors stay accountable for their manufacturing and clinical networks, even when they do not control the facilities where the work is carried out. Recent regulatory setbacks linked to third-party sites show how quickly this can affect a development programme.
The author also points to the handoffs between suppliers as the place where risk builds up. Choices made at one stage shape the options available at the next. Knowledge can be lost when data changes hands, and accountability can become blurred. This is especially true for complex modalities such as antibody-drug conjugates, cell therapies, radiopharmaceuticals and RNA medicines.
Several experts quoted in the piece favour “intelligent integration”: combining the depth of specialists with an integrated way of working. The test is whether a specialist’s added value outweighs the coordination cost of one more handoff. The article recommends that sponsors keep control of development data, analytical methods, batch history, decision rationale and audit trails, and that contracts allow data and activities to be moved between providers.
Geopolitics is the third theme. Tariffs, biosecurity legislation and supply chain resilience are turning the location of operations into a strategic choice. On the policy side, the article looks at the Critical Medicines Act and the proposed European Biotech Act.
EUCROF’s position
As the European CRO Federation, EUCROF brings the voice of CROs from across Europe into this debate. Its contribution to the article can be summarised in five points:
- From cost to complexity. CROs were originally seen largely as a way to reduce costs. Today they are increasingly a solution to complexity.
- Part of Europe’s research infrastructure. CROs are not only execution partners. They are part of Europe’s operational infrastructure for clinical research.
- Informed choices for sponsors. Trials are now global, patient populations are more narrowly defined, and data and technology requirements keep growing. Sponsors need sound judgement on where to run a trial, which sites to involve and which technologies to adopt.
- Policy engagement. EUCROF is working with the European Medicines Agency on the Critical Medicines Act. It supports the Act’s ambition and believes that faster authorisation and greater harmonisation would help reduce fragmentation.
- Investment in the ecosystem. Europe also needs sustained investment in clinical research infrastructure, digital capability, clinical sites and skilled people.
Europe’s diversity is an asset; fragmentation is not.
EUCROF, European Biotechnology Magazine
Why it matters
Decisions about outsourcing models, supply chains and trial location are being reconsidered across the sector. In this context, EUCROF’s message is that CROs are partners in building a clinical research environment in Europe that is more competitive, more resilient and better connected. The goal is a research ecosystem that makes the most of Europe’s diversity, supported by harmonised rules and by investment in infrastructure and people.
We thank European Biotechnology Magazine and the author for the opportunity to contribute to this discussion.
Source: Victor Kotsev, “Europe rethinks the CRO-CDMO model”, European Biotechnology Magazine, 2 November 2026.
