Platform to Digitally Transform Clinical Studies

Tata Consultancy Services, has launched a new version of the Metadata Registry and Transformation (MRT) Platform that helps life sciences companies streamline their clinical data management by automating clinical study design and set up and conversion of clinical data into standard formats for greater interoperability across the clinical trial phases. The MRT platform is part of TCS' Advanced Drug Development (ADD) suite of cloud -based clinical platforms, which are powered by a cognitive engine. The latest version comes with a modernized automation engine and offers significantly enhanced capabilities across both its modules of Metadata registry and Data transformation.

Clinical Metadata Registry helps create and manage a metadata library to accelerate clinical study set-ups and consumption across various study phases. The metadata backbone across clinical trial phases ensures a seamless exchange of information across phases within and outside the company. This enables a seamless cascade of changes in metadata vertically and horizontally across clinical trials. Powered by TCS' unique code generation engine, the component automates the conversion of clinical data to Clinical Data Interchange Standards Consortium (CDISC) or sponsor -specific standards.

TCS has successfully implemented the platform at a leading pharmaceutical company, Boehringer Ingelheim, helping it revolutionize its clinical development process. Andrea Rauch, Head, Clinical Data Standards and Business Capabilities, Boehringer Ingelheim, said, "With the successful roll -out of MRT, we are able to maintain and govern our company, therapeutic area, and project standards using configurable workflows while pushing our study metadata to our EDC system with the click of a button. This is a first step and further releases will offer us an opportunity to revolutionize our clinical development by automating the process of converting study data to submission-ready SDTM data. This implementation is part of Boehringer Ingelheim's Biometrics and Data Sciences Strategy to set-up and conduct clinical studies and analyze data while supporting our mission of bridging data to solutions."