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The Challenge

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.

  • Greater visibility into TMF completeness timelines and associated costs

  • More direct access to documents and audit trails

  • Greater transparency around end-of-study processes

  • Cost-effective and scalable

The Solution

Trial Interactive provided Enterobiotix with a functional service provider (FSP) model that combined its validated off-the-shelf eTMF system with flexible oversight services. The team helped Enterobiotix establish its own in-house eTMF while providing expert guidance on SOPs, implementation, and risk-based compliance strategies from industry veterans.

  • Hybrid approach allowed Enterobiotix to maintain direct control of its systems while leveraging Trial Interactive's TMF processing and oversight services on an as-needed basis.

  • Connected CTMS and eISF systems created an integrated eClinical platform that met evolving ICH standards without requiring additional internal resources.

The Impact

  • Established an independent in-house TMF, reducing reliance on CRO-managed processes and gaining full visibility into costs

  • Achieved full TMF oversight without adding full-time headcount

  • Gained direct, unrestricted access to all documents, audit trails, and metadata for the first time

  • Reduced costs by working on actuals rather than fixed consultant or CRO hourly rates

  • Implemented integrated eTMF, CTMS, and eISF systems with seamless connectivity

  • Received ongoing product updates aligned with new ICH standards at no additional cost

  • Established KPI-driven metrics and reporting for continuous compliance monitoring

  • Created a scalable solution that grows with the company's needs