Efficient clinical trials are key factors in reaching the market first. And with the EU clinical trials directive transforming into a clinical trials regulation, the requirements for the trial master file (TMF) are increasing. One of the changes the clinical trials regulation entails is the need to ensure that the TMF is readily available and accessible at all times, but how do companies ensure that their TMF will be in compliance?
Many companies have a hybrid TMF for both paper and electronic files. This is a challenge during authority inspections and, in particular, on multinational trials. But is the solution to have an eTMF? A TMF or an eTMF consists of input from many different stakeholders and is most likely to affect a series of IT systems. To identify the location of the documentation and create an overview, information must be collected from every business unit involved in the TMF/eTMF.
NNIT can help you become compliant and enhance your inspection readiness. The first step is to make a gap analysis. NNIT’s gap analysis consists of several parts:
Version 3.0 of the TMF reference model has been available since June 2015. If your company is following v2.0, this will entail remapping of your TMF structure against the updates in v3.0. We encourage you to investigate the changes and to consider how they impact your TMF. NNIT is also involved in the TMF reference model working group, Inspection readiness and consultant Dorte Frejwald has personal experience with inspection preparations.