Leading Massachusetts Clinical Research Companies and Organizations Build Bridges to Life Sciences Centers of Innovation in Europe and Latin America

Four organizations well-recognized for their individual innovations 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 consortium’s members include Tufts Medical Center’s Institute for Clinical Research & Health Policy Studies; Phase Forward (NASDAQ: PFWD), a clinical trial and drug safety software company; BBK Worldwide, a clinical trials enrollment management company; and Court Square Group, a consulting firm in life sciences IT and regulatory compliance. The Massachusetts Office of International Trade and Investment (MOITI) tapped these organizations to help it compete with similar groups from California and North Carolina in capturing an agreement that linked Massachusetts with the Lombardia region of Italy. The Consortium completed its initial work with Lombardia this month with the submission of its report outlining a multi-year plan to enhance this region’s clinical research and life sciences infrastructure to the Lombardia Ministry of Health, which then indicated it was prepared to move to the next stage of the multi-year project. Italy currently has only about two percent 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. "The success of the Clinical Research Consortium of Massachusetts means job creation for Massachusetts,” said Daniel O’Connell, Massachusetts Secretary of Housing and Economic Development. "The commonwealth is home to one of the world’s leading life sciences clusters and with this partnership we have an opportunity to continue to lead in life sciences innovation.” Today, the Secretary joined the CRCM members to welcome 8,500 members of the Drug Information Association from 56 countries who have gathered in Boston for their 44th annual meeting. The meeting continues through Thursday, June 26. Lombardia is only the first of many such initiatives planned by the consortium. The CRCM joined Governor Patrick and MOITI at the BIO conference in San Diego last week to represent Massachusetts at the international meeting. Currently, the consortium is in talks with government and life sciences leaders in three countries in South America, and two others in Europe. "Biopharma companies are increasingly conducting complex clinical trials involving thousands of patients at multiple locations around the world,” said Robert Weiler, President and CEO of Phase Forward. "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.” "Developing an outstanding infrastructure to facilitate the highest quality clinical research is good for the biomedical research enterprise, and maximally benefits patients and public health,” said Harry Selker, MD, MSPH, Executive Director for the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. "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.” The National Institutes of Health records more than 57,000 clinical trials conducted in 157 countries, according to the National Library of Medicine. "With increasing globalization of clinical trials, study sponsors are looking for a single entity to which they can turn for support with the myriad tasks involved in clinical research. Our consortium provides the full range of expertise they will need,” said Keith Parent, CEO of Court Square Group, citing ethics committee liaison, consolidated data collection and information management, and GCP training as examples of the support services it could provide. "Lombardia has the basic infrastructure needed to participate in clinical trials management,” Parent said, "but they want to elevate their game to a world-class level. We’re going to help them do that.”