Profil Institute and LMC Diabetes Launch Strategic Partnership to Conduct Cross-Border Multi-Site Trials in Diabetes and Metabolism

Collaboration Brings Together Leading U.S. Metabolism-Focused CRO and Largest Canadian Diabetes Site Network SAN DIEGO AND TORONTO, June 10, 2016 /PRNewswire/ –  Profil Institute for Clinical Research, a science-driven clinical research organization (CRO) focused exclusively on metabolic diseases, and LMC Diabetes & Endocrinology, North America’s largest network of investigator sites for diabetes clinical research, announced today a strategic alliance focused on the conduct of cross-border, multi-site clinical research of investigational drugs and devices for diabetes and related metabolic disorders. Under the terms of the agreement, Profil Institute will expand its investigator network to include LMC’s 13 metabolism-focused clinical research sites in Canada. Profil Institute will also provide clinical development planning as well as oversight of regulatory submissions to the U.S. FDA and Health Canada. Profil Institute is the only full scope CRO in the U.S. that is exclusively focused on metabolic diseases.  The company’s experience encompasses every clinically relevant drug class in diabetes, including early phase studies for many of the diabetes medications and devices on the market today. Headquartered in San Diego, Profil Institute operates a dedicated clinical research facility that has completed over 240 phase I-IIa studies, as well as a network of more than 50 partnering sites for multi-center trials, which will now be expanded to include LMC’s 13 metabolism-focused sites in Canada. LMC is the largest private diabetes clinical research network in North America. The company has conducted over 600 clinical trials across its 13 centers in Canada.  LMC sites adhere to 21 C.F.R. (Parts 50, 56), 45 C.F.R. (Part 46) and GCP standards to ensure clinical data is accepted by international regulatory agencies, including...