How a UK Biotech Built Its Own TMF Infrastructure Without Adding Headcount

Enterobiotix, a clinical-phase pharmaceutical firm developing best-in-class therapies for gut health, was at a pivotal stage of growth where establishing its own trial master file (TMF) infrastructure had become a strategic priority. Like many early-phase biotechs, Enterobiotix had been operating without a proprietary eTMF, relying on CRO-managed TMFs and the processes that came with them. While this is a common and pragmatic approach in early clinical development, as the company’s pipeline matured it became clear that direct ownership of its TMF would be essential for long-term inspection readiness and operational control.

As a pre-commercial biotech with a lean team, Enterobiotix wanted to build its own eTMF capability to gain full control and inspection readiness without the overhead of building an entirely in-house function from scratch. Experience with CRO-managed TMFs also highlighted important considerations for the company’s next phase.