Gone were the days when a Sponsor or the initiator of a clinical trial would worry about comprehensive Trial Master File (TMF) management, navigating through the complex structure of paper documents piled up. With the advent of digitalization, paper documents were converted to electronic formats with a hope that the situation would be any better for TMF compilation, creation, storage, and management. But the data accessibility has become even more challenging in the digital world with respect to different business scenarios.

The main purpose of converting Trial Master Files to electronic format was to enhance accessibility throughout the lifecycle. However, different types of business scenarios challenge the accessibility in different ways:

• The first business scenario could be when a sponsor works with a CRO and restricts the latter to access the TMF. At that time, sponsor might hold back the whole & sole responsibility of maintaining the TMF documentation using an eTMF wherein, the CRO needs to submit all the paper documents on a regular basis. Upon receipt, the submitted documents are scanned and uploaded onto eTMF by the Sponsor and the CROs, too, maintain electronic versions of the documents submitted to keep track of what was sent. In this scenario, the chances are high for trial costs to be increased with two electronic versions of trials maintained. And also poses the challenge and the complexity that involves enroute successful compliance.
• Second in the row is when a sponsor outsources TMF management to a CRO. In this case, the CRO’s SOPs restrict sponsor to access the TMF. As a result, the sponsor may have to go to CRO’s location for periodic reviews and if required, need to go through multiple workarounds. This scenario not only increases the chances of inefficient TMF uploads but also prove to be costly.
• Against the two cases discussed above, the sponsor can delegate TMF management responsibility to the CRO wherein he would be given round-the-clock read-only access to the eTMF to validate files remotely and ensure the quality on par with compliance standards. However, the sponsor cannot contribute documents to the file thus forced to maintain a separate TMF and/or merge the documents with that of the CROs at the end of the study. Even this approach proves to be expensive.

In the above discussed scenarios, the limited TMF access stands as the biggest challenge both for Sponsors and CROs. Even if the documents are uploaded to electronic Trial Master File (eTMF) system, the restrictions to user roles object updated contribution to TMF and accessibility. In order to ensure the TMF is audit-ready at any given point of time, and in any business model, CROs and sponsors must adapt to a system which provides ongoing-based TMF contribution. To do so, integrating a seamless, end-to-end Etmf application seems to be a reliable solution to effectively address the industry challenges.