Collaboration is at the heart of most medical breakthroughs. But too often, outdated clinical information management can make working relationships difficult. For instance, clinical research sites struggle when made to force fit proprietary solutions to meet partner needs. In fact, everyone involved in clinical suffers from the chaotic number of applications and archaic IT infrastructure. Not only is this frustrating, but it is also incredibly counterproductive.
Legacy electronic Trial Master File (eTMF) systems are built on proprietary data standards or old file sharing tech. Unfortunately, these approaches block the collaboration needed to develop a Trial Master File (TMF) that meets quality, timeliness, and completeness standards.
LifeSphere electronic Trial Master File (eTMF) System is First to Use New Data Exchange Standard
ArisGlobal is forging a new path. ArisGlobal’s LifeSphere electronic Trial Master File (eTMF) system is enhancing collaboration at the center of the clinical research enterprise. The new ArisGlobal LifeSphere eTMF system provides real-time file sharing. That means timely updates and more complete documents. It means clinical operations does not have to go back months or years to recreate study decisions for the Trial Master File (TMF).
LifeSphere electronic Trial Master File (eTMF) system is the first eTMF system built using the TMF Reference Model standard document types and the eTMF Exchange Mechanism Standard. This is an open standard developed by an industry consortium. It enables Clinical Sites, CROs, Sponsors, and other stakeholders to connect into the eTMF as a single source of truth. All stakeholders who adopt the standard can contribute to the TMF, ensuring timely updates to documents while ensuring they are higher quality and more complete.
Learn more about LifeSphere eTMF by attending our upcoming webinar discussing the challenges of document management, specifically the Investigator Site File (ISF). We will host our colleagues from eISF solution provider Complion Inc. and the Leukemia and Lymphoma Society.
Within clinical trial sites, LifeSphere eTMF makes it easier to communicate using an electronic Investigator Site File (eISF), also known as the Regulatory Binder. The eISF provides sponsors and CROs a single point to connect their eTMF and other document management systems with clinical sites. With an eISF, sites can stop managing numerous portals for each sponsor and CRO.
Because LifeSphere electronic Trial Master File (eTMF) system is built on the open exchange standard, there is no added burden for clinical sites to onboard new technology or methods. Sites just use the standard with their existing eISF system. This means more clinical research sites will have the opportunity to participate in studies without additional workflow problems.
To learn more, on how clinical research sites are ensuring audit readiness of documents needed in the Trial Master File (TMF), register here for the webinar, “ArisGlobal & Complion Collaboration – Clinical Site Audit-Readiness & TMF Health”.