Clinical Operations Buildout for US Biotechnology’s European Expansion

We placed EU-based CPMs, improving oversight, vendor relationships, and study management for a US biotech.

A US-based biotech firm was keen to establish a presence in Europe and sought guidance on the most effective approach. While they managed much of their CRO oversight from the US, significant time zone challenges led to delays and overwork, impeding progress on European studies.

The Challenge

Operating solely from the US, the team struggled to respond promptly to inquiries during UK/EU business hours. This challenge hindered their ability to foster strong relationships with European vendors and ensure efficient CRA oversight. They needed a more effective way to manage European operations and enhance vendor relationships.

Solution

Our team collaborated with the VP of Clinical Operations and the HR department to identify the ideal candidate profile. The candidate needed to possess strong language skills for effective communication with local EU CRAs and sites, and extensive experience in biotech/pharma as a Clinical Project Manager (CPM) with a solid understanding of oversight processes. Given the lack of physical presence in Europe, we recommended a contract/freelance service offering to save time and money, eliminating the need to establish a local entity.

Result

We successfully provided the biotech firm with an experienced Clinical Project/Oversight Manager based in Europe, ensuring smoother project management on the ground. This arrangement enabled the internal team to focus on US studies, staying on track with timelines and budgets. Weekly meetings were scheduled between the Clinical Operations teams to ensure regular engagement and timely resolution of any issues.

Final Outcome

Two years later, we have partnered with the biotech firm on another CPM search, and we now have two EU CPMs on the ground to oversee the study’s progress effectively.

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