Aurotech, a management and IT consulting firm, has launched the Drug Lifecycle Tracking Application (DLTA). Through DLTA, Aurotech helps companies simplify work and process management across the entire drug development cycle.
"We believe we can simplify drug development through better workflow solutions, empowering pharmaceutical and research organizations to focus on what's really important: creating new drugs that lead to a better quality-of-life," said Matt Mitchell, director of work management solutions at Aurotech.
DLTA provides a new visibility into the way companies test and make new medicines, and helps those companies meet the regulatory demands of the FDA. For a CRO, DLTA can be implemented to improve clinical trial workflows across large teams or projects. For a pharmaceutical organization, the solution can function as an end-to-end work management platform, where only disparate systems have existed before.
"We help companies break down the complex steps necessary in preclinical studies and clinical trials so they can more easily manage and document project and regulatory milestones," said Mitchell. "The industry has never had an advanced tool to track the entire drug development lifecycle—from research initiation all the way to FDA submission."
DLTA is built on a leading project-management platform overlaid with intimate knowledge of drug development and FDA requirements. The result is custom-mapped work management for the entire drug development lifecycle. Users have the ability to track, manage and monitor projects from centralized and easy-to-use dashboards, and in-system collaboration improves the effectiveness of handoffs between teams. When it comes to IND or NDA application submission, DLTA ensures that every step is compliant and complete.
“Having this full visibility in drug development projects is ‘mission critical,’" said Mitchell. “FDA re-submissions can cost millions and take months to fix. Imagine if the application was for the next life-saving treatment. With DLTA, the cost and time savings will be significant, and it will help bring new medicine to patients more quickly."