Montrium, clinical trial technology specialists and electronic content management software providers, have announced the commercial release of the eTMF Navigator, an interactive intelligence dashboard integrated into eTMF Connect. Armed with the right information, clinical teams can now drive improvements in their processes, and better manage their clinical trials.
Trial Master Files (TMFs) represent a significant challenge in today’s clinical trial environment, due mainly to the sheer volume of artifacts and the distributed global nature of clinical studies. Traditionally, Excel Spreadsheets have often been used as trackers to understand the level of TMF completeness and combat these challenges. However, trackers and other homegrown tools only give minimal insight into the document status and are not connected to the source of information.
The eTMF Navigator leverages all of the information and documentation that surrounds your clinical trial and provides a visual, real-time, multi-dimensional view of TMF completeness. Clinical users now have the ability to manage their ongoing studies directly in the navigator by updating artifacts, sites or country information from a single location. As the study progresses, users can dynamically view the status of specific TMF artifacts and gain greater insight into clinical trial events and compliance. In addition, the introduction of the eTMF Navigator gives greater flexibility during audits and inspections with a dedicated inspector view. The eTMF Navigator tool is integrated with eTMF Connect, Montrium’s Electronic Trial Master File (eTMF) application, bolstering its already comprehensive set of features.
“Traditionally, clinical teams have found it increasingly difficult to leverage TMF information to drive better clinical decisions due to its inherent complexity.” said Paul Fenton, president & CEO at Montrium. “The eTMF Navigator cuts through this complexity, allowing users to navigate across hundreds of thousands of TMF artifacts from a single centralized location, enabling them to identify and instantly modify all available, expected or missing artifacts in one interface.”
The eTMF Navigator is the first release of Montrium’s Navigator Tools, designed to provide users of the Montrium Connect platform with interactive dashboards to manage better their regulated activities, as well as extract critical business intelligence to drive improved processes. Montrium continues to make significant investments into its subscriber community, with plans to roll out the Navigator Tools to RegDocs Connect and its Quality Management applications shortly.
