About The Client
The Integrated Management Platform to Accelerate Clinical Trials (“IMPACT”) program is a partnership between the Creative Destruction Laboratory (CDL) network and the University of Calgary. The program enables medical device and drug innovation by assisting Life Sciences Ventures quickly and easily navigate the complex regulatory requirements related to clinical field trials. A lack of experience dealing with regulatory agencies such as Health Canada and the FDA and conducting field trials can slow a Venture’s progress, thus having a significantly negative impact on their overall success.
What We Did
Big Bear is collaborating with IMPACT to design, implement and deploy software called TRACR, for Tailored Regulatory, Audit, Compliance & Reporting (“TRACR”; ‘trækə(r)’), that supports Ventures in field trials and the commercialization of their product. The software will provide joint planning & action management, document management, automation, workflow, and be the foundation for lessons learned. The software is designed to grow more sophisticated over time with new Ventures being able to leverage templates developed based on IMPACT’s experience supporting previous Ventures.
