Montreal-based contract research organisation (CRO) ethica Clinical Research has set up a joint venture with India’s diversified Matrix Group.

The new company, ethicamatrix CRO Pvt Ltd, will manage contract research services in India on behalf of North American and European pharmaceutical and biotechnology companies, as well as clients from the domestic life sciences sector. According to ethica, it is the first Canadian CRO to establish a joint venture with a comparable Indian company and the first solely Canadian-owned CRO to position itself in India.

Distinct from Matrix Laboratories, the Indian active pharmaceutical ingredient manufacturer in the US Mylan Laboratories acquired a controlling stake last year, Matrix Group’s activities span the life sciences, aqua technology and agriculture. The group’s chief executive V. Siva Prasad said the formation of ethicamatrix would have a marked impact on the evolution of clinical research in India, where the industry had “essentially been self-regulated”. As the contract research sector expanded in India, ethicamatrix would “lay the foundation of good ethical and clinical practices in this industry”, he commented.

The Canadian partner, which has only been operating since 2002, noted it was the first and only CRO in the world to earn full accreditation from the US-based Association for the Accreditation of Human Research Protection Programs (AAHRPP). As such, ethica was “uniquely certified to bring the highest of global standards to contract research in India. In due course ethicamatrix would also be seeking AAHRPP accreditation, ethica added.

Initial focus

The new joint venture’s initial focus will be on clinical research services including study monitoring, data management and investigator training. According to ethica, a number of leading teaching hospitals in India are already seeking partnerships with ethicamatrix.

Western clients for the joint venture, which will have facilities in Matrix’s base, Hyderabad, would benefit from the “highly cost-effective” Indian research environment and a “hugely enhanced” ability to recruit clinical trial participants, especially in areas such as bacterial conjunctivitis where the disease incidence was minimal compared with India, ethica said. The venture would also serve as “a conduit and facilitator” for Indian companies conducting research in their home market and needing North American data for their products.

“Companies can develop their products in India and be assured that their research data will pass the scrutiny of Western regulators,” commented Murray Jensen, ethica’s director of clinical and scientific affairs. The aim, he said, was to build ethicamatrix into “the premier self-regulated CRO in India, and thereby help ensure by our performance, example and leadership both the safety of clinical trial participants and the integrity of clinical trial results throughout the industry in India”.

The Canadian CRO pointed to the Indian government’s interest in establishing a “viable and unimpeachable contract research industry”. In this spirit, it planned to invest more than US$50 million in the Hyderabad facility of the National Institute for Pharmaceutical Education and Research.