Four organizations involved in clinical research have joined together to create the Clinical Research Consortium of Massachusetts (CRCM),  a cooperative enterprise that supports knowledge and technology transfer between Massachusetts and other international regions interested in building clinical research centers of excellence. The group’s first work is with the Lombardia region of Italy.

The consortium's members include Tufts Medical Center's Institute for Clinical Research and Health Policy Studies, eclinical company Phase Forward, clinical trials enrollment management company BBK Worldwide, and life sciences consulting firm Court Square Group.

The Massachusetts Office of International Trade and Investment picked these four organizations to help it compete with similar groups from California and North Carolina.

The consortium has already completed its initial work with Lombardia with the submission of its report to the Lombardia  Ministry of Health, outlining a multi-year plan to enhance this region's clinical research and life sciences infrastructure. The Lombardia Ministry of Health indicated it was prepared to move to the next stage of the multi-year project.

According to the consortium, Italy currently has only about 2% of the multi-billion dollar European market for clinical trials, due, in part, to a perception that studies are difficult to conduct there.

"Establishing a regional center of excellence not only will dispel this misperception, but also make giant strides in enhancing drug development and getting new treatments to market sooner by improving access to a very sophisticated and resource-rich region," said Bonnie Brescia, founding principal of BBK Worldwide.

Lombardia is only the first of many such initiatives planned by the consortium. The CRCM joined Governor Patrick at the recent BIO conference in San Diego. Currently, the consortium is in talks with government and life sciences leaders in three countries in South America, and two others in Europe.

At the Drug Information Association’s 44th annual meeting in Boston Tuesday, Paul Bleicher, founder and chairman of Phase Forward, said among the countries the consortium has already been approached by are Brazil and Chile. Robert Weiler, president and chief executive officer of Phase Forward, said the biopharmaceutical companies are increasingly conducting complex clinical trials involving thousands of patients at multiple locations around the world.

“Working together with our consortium partners, we can create a framework that combines our technology solutions with efficient clinical research practices to enable regions such as Lombardia to run clinical trials more quickly and safely," Weiler said.

Harry Selker, M.D., MSPH, executive director for the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, said developing an outstanding infrastructure to facilitate the highest quality clinical research is good for the biomedical research enterprise and patients.

"The Clinical Research Consortium of Massachusetts will enable Tufts Medical Center clinicians and researchers to form partnerships with their counterparts in Italy and, we hope, elsewhere in the world, to share research best practices in addressing the many health problems faced by patients and the public," said Selker.

Keith Parent, CEO of Court Square Group, said that with increasing globalization of clinical trials, sponsors are looking for a single entity to support with the myriad tasks involved in clinical research. “Our consortium provides the full range of expertise they will need. Lombardia has the basic infrastructure needed to participate in clinical trials management, but they want to elevate their game to a world-class level. We're going to help them do that," Parent said.

Daniel O'Connell, Massachusetts’ Secretary of Housing and Economic Development, said the success of the CRCM means job creation for Massachusetts.