Document Management

The Foundation of Every Inspectable Trial

The Trial Master File is the definitive record of how a clinical trial was conducted, and for any regulatory inspector, it is the first place they look. Under ICH E6(R3), sponsors are required to maintain essential records that are complete, accurate and retrievable throughout the trial lifecycle and beyond. This is not simply an administrative obligation. It is a direct reflection of whether a sponsor has genuine control over their clinical programme.

In practice, TMF management is one of the most consistently underestimated challenges in clinical operations. Records are spread across sponsor and CRO systems, filing standards vary by study or by team, and site level documentation often receives too little attention until it is too late. These are not rare scenarios. They are common. The consequences, whether during an inspection or at study closeout, can be significant.

Our Approach

Arithmos brings together regulatory expertise, operational experience and a practical understanding of how TMF programmes function day to day. We work with sponsors to build essential records frameworks aligned to ICH E6(R3) and current industry best practice, and we provide the people and processes required to sustain them.

This means working with you from the ground up. We define what good looks like for your organisation, establish the metrics that indicate whether your TMF is healthy, and put in place the governance and operational support needed to maintain that standard across your portfolio. Where migrations are required, whether transitioning away from a CRO system, bringing records in house, or integrating documentation following a merger or acquisition, we manage the process with the rigour it demands.

For sponsors who need more than advisory support, we also provide embedded TMF management. Our experienced professionals operate as an extension of your team, taking ownership of day to day TMF activities, maintaining filing standards across studies, and ensuring your records remain audit ready at every stage.

Importantly, we establish TMF health metrics that provide a clear and consistent view of completeness, timeliness and quality at any point in the trial. These metrics matter beyond compliance. They enable meaningful oversight. How they are used to drive operational decisions and vendor performance is addressed further within our Trial Oversight offering.