Profil Institute for Clinical Research, a science-driven CRO focused exclusively on metabolic diseases, and LMC Diabetes & Endocrinology, North America's largest network of investigator sites for diabetes clinical research, have announced 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.

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 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 the FDA in the U.S. and the EMA in Europe. 

"LMC has a long-standing track record of quality, success and expertise in conducting phase II/III metabolism-focused clinical trials, and we are delighted to welcome them as a strategic partner," said Dr. Marcus Hompesch, Profil Institute chairman and CEO. "It is clear that cross-border development programs offer significant opportunities for cost and timeline efficiencies, as well as expanded patient-access. This partnership represents an alliance between two metabolism centers of excellence building new and strengthening existing processes for cross-border clinical research and regulatory project management."

"Profil Institute's focus on CRO services for metabolic diseases, most notably its unparalleled expertise in diabetes, and its track-record of rigorous adherence to quality and ethical standards in the U.S. fully aligns with LMC's proven capabilities in multi-site clinical research conduct in Canada," said Karri Venn, president of LMC's Research Division. "Together, we will be able to offer a compelling solution for the many sponsors who are seeking high quality CRO services coupled with deep metabolism expertise, as well as the efficiencies provided by conducting U.S./Canada cross-border clinical research."   

Cross-border drug and device development programs, with the right project management and monitoring oversight, can provide opportunities for cost and timeline efficiencies, as well as expanded patient-access. Health Canada, the equivalent of the U.S. FDA, has a regulatory process that fosters the launch of clinical trials within 30 days. Other incentives include competitive labor and facility costs, a favorable exchange rate for U.S. companies, and government tax credits of 15% to 32% for Canadian corporations.