WHO ARE WE

BioPharma Consulting is a specialist consultancy focused on clinical trial delivery and oversight, and site engagement services. The company was created to enable sponsors to close the gap between what regulators expect on paper and what happens at investigator sites.

We understand the day-to-day realities of running global trials: competing priorities, limited internal capacity, and heavy reliance on CROs and vendors. Our role is to provide an independent, expert layer of oversight that protects patients, data integrity, and your reputation.

OUR BACKGROUND

BioPharma Consulting was founded by Mike Somers, a clinical research professional who has worked in industry for 28 years with hands-on experience in:

• Site monitoring and management.
• Vendor oversight and management.
• Audit and inspection preparation.
• Clinical operations leadership.

Mike formed BioPharma Consulting in 2018 to support the biotechnology sector in building strong foundational relationships with both site and CRO staff, with a clear focus on ensuring outsourced activities and deliverables are performed in accordance with regulations, guidelines, and statements of work.

Mike works closely with several other team members across the globe, each with experience and backgrounds that enable them to seamlessly transition into teams and generate benefits to the sponsor from day 1.

The team includes former CRAs, Clinical Site Liaisons, auditors, and regulatory specialists who have worked across phases I–IV and multiple therapeutic areas. They bring a practical understanding of
what sites, CROs, and sponsors need to work together effectively.

WHAT MAKES US DIFFERENT

Niche focuses on oversight and liaison functions – we are not a full- service CRO, which allows us to stay independent and laser-focused on sponsor obligations and site needs.

Senior-level involvement – key consultants can remain available throughout each engagement, guiding regional consultants and ensuring consistency in delivery.

Scalable model – whether you are a small biotech running your first pivotal trial or a larger sponsor with multiple ongoing studies, we right-size the model to your portfolio and risk profile.