Europe has spent years working to make clinical trials faster and more efficient. We have the Clinical Trials Regulation, CTIS, harmonised submissions and a range of initiatives designed to improve competitiveness. These efforts have helped address many longstanding challenges in the regulatory process.
However, discussions about clinical trial performance increasingly highlight another issue: what happens after regulatory approval. While the pathway to approval may be becoming more aligned across Europe, site contracting and study activation can still take several months. This raises an important question. As Europe continues its efforts to enhance clinical research competitiveness, should more attention be given to the operational processes that sit beyond regulatory review?
At a recent discussion on Europe’s clinical trial competitiveness, one observation stood out. Regulatory harmonisation may have improved the front end of the process, but significant variation remains in how studies move from approval to activation. Site contracting is one example and may represent an area where meaningful improvements could be achieved.
A published study of a multinational European clinical trial involving more than 80 sites across nine countries found a median of 194 days to conclude clinical trial agreements, making contracting the longest stage of site initiation.
During the panel discussion, a more recent figure of approximately 183 days for European site contracting was also referenced. While I have not yet identified the underlying dataset and therefore cannot validate the number, the overall message remains consistent. Contracting timelines continue to represent a significant component of study startup across many European markets.
There is no single answer. Clinical trial startup involves multiple stakeholders, processes and approval pathways, all operating within different healthcare systems and regulatory environments.
However, fragmentation appears to be a significant contributing factor. Different contract templates, budgeting approaches, institutional processes and approval requirements can all add complexity to the contracting process. In some cases, activities that could potentially take place in parallel are still conducted sequentially, extending timelines before a study can begin.
Budget negotiations can add a further layer of complexity. Sponsors and sites may have different expectations regarding costs, while internal alignment on budget allocation can also take time. The result is often a prolonged contracting phase before patient recruitment can begin.
France provides an interesting example of a different approach. The Convention Unique establishes a standardised framework for agreements between sponsors and healthcare establishments participating in commercially sponsored clinical research. France has also introduced associated approaches to standardising costs and monitoring performance.
The panel discussion suggested that these measures have contributed to improved efficiency. While I have not found sufficiently robust evidence to validate the frequently cited 40% improvement figure, the broader principle is worth examining. Rather than focusing solely on accelerating individual negotiations, France has sought to reduce variation within parts of the process itself.
Spain provides another useful comparison. It has introduced several measures to facilitate clinical trial activity, although it would be inaccurate to suggest that it operates under a single national contracting model. Its own guidance acknowledges that a single contract model is not currently available.
That is precisely why these examples are valuable. The goal should not necessarily be to identify a single country that has found the perfect solution. Rather, it is to understand which approaches consistently improve efficiency while maintaining the flexibility required by different healthcare systems, institutions and legal frameworks.
Probably not.
There are legitimate reasons why contracts require local provisions. Liability, indemnity, intellectual property, data protection, institutional governance, investigator responsibilities and national legal requirements all need to be considered. Attempting to create a fully standardised contract for every situation across Europe would likely create challenges of its own.
However, the question remains whether greater consistency could be achieved in areas where local variation provides limited additional value.
Could Europe adopt a standard core contract with clearly defined local adaptations? Could site costing be based on a more consistent methodology? Could routine financial terms become more aligned? Could electronic contracting become more widely adopted? Could administrative approvals take place in parallel where appropriate? And could median contracting timelines be measured and reported more consistently?
None of these ideas would eliminate the need for local flexibility. However, they could provide opportunities to reduce unnecessary complexity and create a stronger evidence base for future improvements.
Contracting timelines are influenced by many stakeholders, and responsibility is rarely concentrated in one area.
Sponsors and CROs also contribute to the challenge. Protocols continue to become more complex, often incorporating additional technologies, assessments, devices and operational requirements. These decisions can increase the burden on sites and affect both startup and recruitment timelines.
The panel discussion highlighted this point. Trial complexity can influence contracting discussions, budget negotiations and site readiness, making study startup more challenging regardless of the efficiency of underlying processes.
This raises an interesting consideration for site selection. Sponsors understandably focus on recruitment potential, therapeutic expertise and patient access. However, operational readiness may deserve similar attention.
Rather than asking only:
"Can this site recruit the required patients?"
it may also be valuable to ask:
"How long does this site typically take to complete contracting and initiate a study?"
Contracting performance may not be the only factor that matters, but it is one that can have a measurable impact on study timelines.
Perhaps the most important point emerging from the discussion is that competitiveness and regulation are not necessarily the same conversation.
Debate around Europe's position in clinical research often focuses on regulatory requirements. Yet many stakeholders would argue that Europe already possesses significant strengths: experienced investigators, high-quality healthcare systems, scientific expertise and access to diverse patient populations.
The opportunity may therefore lie not only in further regulatory reform, but also in improving how these strengths connect operationally.
One speaker described this as moving beyond regulatory harmonisation towards greater operational harmonisation. Whether or not that specific terminology is adopted, the distinction is important. Improving competitiveness may depend as much on execution as it does on regulation.
Discussions about European competitiveness frequently identify areas that could be improved. Equally important is understanding which interventions can deliver measurable results.
One potential next step would be to test some of these ideas through pilot programmes.
For example, a group of hospitals across several European countries could adopt a common core clinical trial agreement, supported by standard costing principles, clearly defined local adaptations and a digital contracting workflow. Timelines from regulatory approval to signed site agreement could then be measured and compared with conventional approaches.
Such an initiative would not answer every question. However, it could provide practical insight into whether greater standardisation in selected areas leads to measurable improvements in study startup.
If successful, the findings could help inform future discussions among regulators, sponsors, CROs, healthcare institutions and industry associations. If not, they would still contribute valuable evidence about what does and does not improve efficiency.
Europe already has many of the ingredients required for successful clinical research: scientific expertise, experienced investigators, established healthcare systems and access to patients. Continued progress may depend not only on regulatory frameworks, but also on the efficiency and predictability of operational processes such as contracting and site activation.
While there is unlikely to be a single solution, targeted efforts to reduce unnecessary complexity and improve consistency could help strengthen Europe’s competitiveness as a destination for clinical research. These are practical, measurable challenges and therefore worthwhile areas for further attention.