As the clinical trial landscape continues to evolve, the adoption of a electronic Trial Master File (eTMF) is becoming the norm rather than the exception. Especially as the health authorities are swiftly moving towards remote and hybrid inspections, which consequently puts sponsors in a situation where they might face inspections more often. Therefore, they are forced to place stronger emphasis on keeping their trial documentation consistently inspection ready.
BSI eTMF offers a solution that can support sponsors in these endeavors by significantly enhancing document management practices and ensuring trial document compliance with regulatory standards.
Whether you’re a small sized life science business or a larger company, BSI eTMF will not only help you ensure regulatory compliance but also improve operational efficiency and collaboration across teams.
Supported by BSI’s structured implementation process, you’ll be able to move your clinical trial documentation into the new system seamlessly and continue the pursuit of achieving excellence in clinical documentation and trial management.
BSI Life Sciences eTMF offers a highly intuitive and configurable platform for optimizing the management of clinical trial documents for any type of life science sponsor and CROs. With the following features, the solution covers the most important aspects of clinical trial document management which support companies to remain ready for audits and inspections.
