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 Many still rely on outdated legacy platforms or homegrown systems that are unable to keep up with the evolving needs of clinical research organizations (CROs) and biopharmas.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.
Electronic Trial Master Files Make for Easier Clinical Data Management
The introduction of electronic Trial Master File (eTMF) systems was a step in the right direction and is the best method to manage the TMF. Because the software is designed specifically to handle the TMF, these systems enable easier Clinical data management and provide a digital framework that aligns with Good Clinical Practice (GCP).
Unfortunately, not all eTMF systems provide the automated tools, flexibility, and ease of collaboration needed in Clinical operations.
For example, the first wave of eTMF platforms fell short of their promise to deliver compliance for collaborative research teams. The Clinical environment is more complex now, with a larger number of clinical endpoints and cross-functional collaborations and requires a system that can evolve with the industry. The migration to hybrid trials accelerated by the pandemic, only exacerbated these early eTMF systems’ collaboration woes. A ten-year upward trend in findings within the TMF proves this point.
eTMF Exchange Mechanism Standard (EMS) Sets a New Bar for Collaborative Systems
The primary failure of these early systems was the inability to share information with other eTMF platforms. This shortcoming continues today within most eTMF systems. The resulting communication barriers stall collaborative efforts because important information can not be easily shared across sites, teams, and organizations. To fix this blockage, a new industry standard was introduced: the eTMF Exchange Mechanism Standard (EMS). The EMS allows technology vendors to translate information from one eTMF system to another, allowing for seamless data sharing and communication.
With EMS, eTMF systems can now be leveraged to their full potential: providing an in-depth, real-time view of every aspect of a trial to stakeholders across sites, countries, and organizations. Providing stakeholders with better control of the study and assurance that health authority inspectors can follow a logical data trail in the event of an audit, the EMS also ensures the protection of the safety, rights, and well-being of patients.
Ensuring Your eTMF System Evolves with You
In addition to EMS, state-of-the-art eTMF systems will have:
- Advanced automation capabilities to free up Clinical teams to focus on high-value initiatives over routine tasks
- An intuitive user experience that is configurable based on individual teams’ wants and needs
- Reliable security that ensures data is managed appropriately
- Built-in compliance mechanisms that are future-proofed via regular cloud updates
- Integration capabilities with other life science research and development tools, like the Clinical Trial Management Software (CTMS) or Electronic Data Capture (EDC) system. As your organization extends or optimizes its technology stack, having the latest automation capabilities in the eTMF solution and Clinical tools is essential to remain competitive
Implementing an eTMF system is a great opportunity to advance the way your organization executes clinical trials; but it’s important to find the right solution for your organization. The essential capabilities your organization requires are unique, and there are many factors to consider; but there are some core requirements that apply to every organization across the Clinical landscape and create truly collaborative, compliant, next-generation TMF management.
To make your search easier, we’ve compiled a list of essential features to consider for your eTMF system. Our eTMF Checklist will help you to evaluate various systems and ensure you’re choosing the best solution for your organization.
Ready to start your research? Download the checklist today.