Solving Cross-Border CRO Oversight Issues Across 14 Countries

Key takeaways

• Without a European entity, a US biotech lacked control over regional trial delivery, facing major site and CRO challenges
• 17 CTLs placed across 14 countries following expert consultation, bringing visibility and structure
• The model evolved into a successful long-term solution and partnership expansion

The challenge

Running clinical trials across new geographies without proper infrastructure can put firms at risk of a range of costly issues, but embedding the right people on the ground can transform struggling trials into high-performing programs.

A US biotech firm approached EPM Scientific as they were struggling with a lack of oversight of their critical trials in Europe, which was completely outsourced to a contract research organization (CRO). Their main concerns were inadequate patient recruitment and retention, engagement and training of site staff and principal investigators (PIs), and CRO oversight issues. 

They were not in a position to set up an entity in Europe, and didn’t have the capacity or network to source talent within this geography, so they sought out our advice on how best to proceed.

The solution

After consulting with the client on their issues in detail, we recommended introducing Clinical Trial Liaisons (CTLs) to provide real-time, in-country support – a solution that has worked exceptionally well for other companies we’ve partnered with. Acting as the sponsor’s representatives, CTLs would be embedded within key trial regions to build stronger relationships with sites and CRO teams, improve training and communication, and proactively solve issues before they escalated. 

Through our specialist contracts division and extensive European network, we sourced, onboarded, and payrolled experienced CTLs across the continent, allowing the firm to scale up operations without establishing a local entity.

Over time, the team grew to 17 CTLs across 14 countries. The success of the model was supported by consistent communication and weekly calls, transparent data sharing, and a collaborative approach to expectation-setting.

The result

The introduction of CTLs was transformative. Patient recruitment and retention improved, oversight gaps were closed, and stakeholder collaboration became significantly more effective. The sponsor was able to regain control of their trials and operate with confidence across multiple European regions, all without the burden of setting up local infrastructure.

Impressed by the value delivered, the client expanded our partnership to include medical affairs, where we built an entire freelance European medical science liaison (MSL) team, including a dedicated MSL Manager, further strengthening the company’s commercial and clinical footprint across the region.

Summary

This project highlights how EPM Scientific operates as a true consulting partner – not just a talent provider. 

By providing the strategy, structure, and cross-border execution, we helped this client take back control of their outsourced trials and proactively prevent future issues, demonstrating EPM Scientific’s ability to consult, solve, and scale in the most complex life sciences environments.