A well-prepared Trial Master File (TMF) is critical to the success of any clinical trial. Because the TMF tells the whole story of a study – including every data point collected and decision made – managing it throughout the course of the trial is challenging. The most recent inspections report from the UK health authority MHRA found that TMF essential documents caused the most findings within commercial sponsor organizations over the last decade and the number is steadily growing.
Clearly, Clinical teams need better tools for compiling TMFs. Many still rely on outdated legacy platforms or homegrown systems that are unable to keep up with the evolving needs of clinical research organizations (CROs) and biopharmas. These decades-old tools – some of which still keep important and sensitive information on paper or in spreadsheet trackers – slow teams down, make it difficult to share information, and allow critical data and essential documents to fall through the cracks.