eTMF systems streamline and organize clinical trial information in a way that’s easier to manage, track, and archive. But if your eTMF isn’t optimized, it can be challenging to reap these benefits. One way to ensure your eTMF operates at its best is to perform a health check.
An electronic Trial Master File (eTMF) serves as a central repository for all the essential documents and data related to the planning, execution and management of a clinical trial. It demonstrates the trial’s compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
Biotech and pharmaceutical companies have increasingly adopted their own eTMF technology to manage their clinical documentation. Bringing an eTMF in-house offers many advantages over traditional paper-based TMFs and even outsourced eTMF models, including increased efficiency, improved collaboration, transparent oversight, and enhanced regulatory compliance.
However, even with the great benefits of eTMF, companies still face challenges with their eTMF systems. These challenges can range from technical problems to user adoption issues and prevent companies from truly getting the value out of their investment.
We often talk a lot about TMF health, periodic reviews, QC, and audits as a way to improve your TMF process. Perhaps your eTMF needs a health check itself? The Daelight eTMF Health Check can help identify impactful and practical changes to improve your eTMF management. But before we dive into what this entails, let’s review a use case.
A Common Story
Once upon a time, there was a small biotech company, let’s call them “Boston Bio.” Boston Bio was developing a new drug for the treatment of pancreatic cancer. To support their upcoming clinical trial, the company recently deployed an eTMF system to manage the documentation and collaborate with their partners.
At first, Boston Bio was happy with its new eTMF system. The system was easy to navigate and seemed to be working well. The company was able to save time and have better oversight of the management of the clinical documentation required in the eTMF.
However, after the first year, Boston Bio began to experience some challenges with its eTMF system. The system metrics were inconsistent, and users began to report problems with the search function. Boston Bio also had difficulty tracking the status of documents in the eTMF.
As a result of these problems, Boston Bio’s clinical trial team was starting to fall behind on filing. The team was having trouble finding the documents they needed, and they were not confident that the eTMF was accurate. Trial team members began relying on other non-validated collaboration and documentation tools.
What if there was a service that could help Boston Bio overcome its eTMF challenges? Luckily, they found one.
The Daelight eTMF Health Check
Boston Bio turned to Daelight Solutions for help. Daelight is an IT consulting company relentlessly focused on meeting enterprise information challenges in the life sciences. Its team of eTMF specialists performed a health check to identify and address the problems with Boston Bio’s eTMF system.
The health check team analyzed the current state of Boston Bio’s eTMF deployment. They also reviewed the company’s use of metrics, identified underused features and recommended best practices, and identified methods to increase user adoption.
Daelight’s team also looked at the SOPs Boston Bio and its CRO were using to support the eTMF system. They checked the utilization of approved SOPs, reviewed the periodic QC process, and identified areas for process simplification.
The Results
The results of the eTMF health check revealed several problems with Boston Bio’s system. These problems included:
- Technical problems with the eTMF system configuration.
- User adoption issues, such as a lack of training and support for the eTMF system.
- Ineffective SOPs for managing the eTMF.
The health check team also identified several recommendations to address these problems, which included:
- Upgrading the eTMF system to improve performance and leverage best practices functionality.
- Providing more targeted training and support for users of the eTMF system.
- Revising the SOPs for managing the eTMF to improve efficiency and effectiveness.
The Benefits
The eTMF Health check helped Boston Bio to identify and address a number of problems with its eTMF system. As a result of the health check, Boston Bio was able to:
- Improve the performance and reliability of its eTMF system.
- Increase user adoption of the eTMF system.
- Improve the efficiency of its eTMF management processes.
- Enhance its regulatory compliance.
Daelight’s eTMF health check also helped Boston Bio save time and money. The company was able to reduce the time it took to manage its clinical trial documentation, freeing up its resource time to focus on delivering life-changing treatments.
Conclusion
The Daelight eTMF Health Check can be a valuable tool for biotech and pharma companies that are using eTMF technology. This proprietary service can help to identify and address problems with eTMF systems, and it can also help to improve user adoption and regulatory compliance.
If you would like to hear more about Daelight’s TMF services, including the eTMF Health Check, we would love to meet you! Join us at the 2023 CDISC TMF Interchange in Baltimore on September 28-29 to discuss your TMF needs. Register today!