Should You Bring Your Trial Master File In-House?

By Michelle Peter and Mike Lynch

When it comes to managing a Trial Master File (TMF) for clinical trials, there are two main options: managing it in-house or contracting with a Clinical Research Organization (CRO) or third party. Managing the TMF in-house allows for greater control and customization, but requires dedicated personnel and resources. On the other hand, contracting with a CRO offers flexibility and potentially reduces costs, but comes with the challenge of relinquishing some control over processes and documentation.

Regardless of the approach chosen, careful attention must be given to ensure the TMF is always inspection-ready. Contracting with a CRO has its disadvantages, including concerns about the quality and consistency of documentation, challenges in communication and collaboration, limited availability and resources, and difficulties in selecting the right CRO. Additionally, there may be extra costs associated with contracting with a CRO. Ultimately, the decision to bring the TMF in-house or contract with a CRO depends on the specific needs and resources of the sponsor, and it is important to carefully consider the implications before making a decision.