GCMI and our preclinical arm also known as T3 Labs is a trusted, proven industry-leading preclinical CRO for medical devices and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, feasibility, and safety and efficacy GLP medical device testing for studies in any therapeutic area and in small and large models. Since January 2012, we have archived more than 80 GLP studies, including more than three dozen in the last two years alone, for leading medical device manufacturers of which more than 65 products have received regulatory approvals.
Awareness of changes in and the current state of the preclinical landscape can make the difference between an efficient pathway for a new medical technology’s regulatory submission or high numbers of wasted “$10,000” days.
Our Director of Scientific Affairs Evan Goldberg has more than 12 years planning, executing and reporting on preclinical studies; GLP, pilot and everything in between. If you are working on a new medical technology, be it a device, therapeutic or combination product, we encourage you to continue reading our annual Q&A on the current state of preclinical work with Evan immediately below.