Lifetrack Newsletter

Volume 8 Issue 7 - november 2007


Canada-based ethica Clinical Research Inc. establishes joint venture with India-based Matrix Group

First Canadian CRO to expand clinical trial management operations to India

Montreal – ethica Clinical Research Inc. (“ethica”), a Contract Research Organization (CRO) headquartered in Montreal has formed a joint venture with the Hyderabad-based Matrix Group. The new company, ethicamatrix CRO Pvt Ltd (“ethicamatrix”), will manage contract research services in India on behalf of North American and European pharmaceutical and biotechnology companies, as well as on behalf of domestic Indian life sciences companies. The initial activities of ethicamatrix will focus on clinical research services including study monitoring, data management, and investigator training.

ethica is the first Canadian CRO to establish a joint venture with a similar Indian firm. Established in 1996 in Hyderabad, Matrix Group is active in the life sciences, aqua technology, and agricultural sectors. ethica is the sole Canadian-owned CRO to position itself in India.

As the first and only CRO in the world to earn full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), ethica is uniquely certified to bring the highest of global standards to contract research in India.

All of ethica's operating procedures have passed the scrutiny and have been fully accredited by AAHRPP. ethicamatrix will implement those identical procedures in India.

The personnel of ethicamatrix will be trained by ethica in accordance with AAHRPP-qualified principles and values. In short, the regimen under which the new company operates in India will precisely replicate that of ethica’s in Canada. In due course, ethicamatrix will also seek AAHRPP accreditation.

ethicamatrix will serve Western life sciences companies that seek to benefit from the highly cost-effective Indian research environment, as well as from a hugely enhanced ability to recruit research participants for clinical trials. For example, if a life sciences company were to pursue the development of a therapy for bacterial conjunctivitis, subject enrollment in Canada would present nearly insuperable difficulties given the rare incidence of the disease here compared to the incidence in India. Life sciences companies faced with similar subject recruitment delays can now engage ethicamatrix to manage their research in India with the full knowledge that their clinical trials will be conducted according to the highest international standards.

“The establishment of ethicamatrix places our company on the global stage, as we can now manage clinical trials in the Americas, Europe and Asia” said Mr. Murray Jensen, ethica’s Director of Clinical and Scientific Affairs. “We can now conduct research originating from anywhere in the world, and use our facilities in Hyderabad to benefit from the welcoming and advantageous Indian environment. Companies can develop their products in India and be assured that their research data will pass the scrutiny of Western regulators. We intend to build ethicamatrix into the premiere 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."

Mr. Jensen added, "For early-stage companies we provide a vital opportunity. Research costs, burn rate, and increasingly slow subject recruitment in the West often exhaust a young company’s venture capital before it can proceed far enough down the clinical trial road to prove its concept. We are in the business of making that company’s research affordable, while performing its research according to international norms."

Mr V. Siva Prasad, Chief Executive Officer of the Matrix Group, commented that, “The formation of ethicamatrix will have a considerable impact on the evolution of clinical research in my country. The arrival of ethica’s standards here, where the contract research industry has essentially been self-regulated, is a tremendously important event. As the contract research industry expands in India, ethicamatrix will lay the foundation of good ethical and clinical practices in this industry.”

It is expected that new business will accrue to ethica in Canada as a result of the profile established by ethicamatrix in India. Many companies in India have begun to participate in the innovative pharmaceutical sector. When these companies seek approval for their therapies in North America, they will potentially generate contract research mandates in Canada. ethicamatrix will then act as a conduit and facilitator for domestic Indian companies doing research in India and requiring North American data for their products.

The Canadian government and its trade commission in India helped facilitate the discussions that resulted in the formation of ethicamatrix. The Indian government played an equally significant role, given its interest in establishing a viable and unimpeachable contract research industry. The Indian government plans to invest over US$50 million in the Hyderabad facility of NIPER (National Institute for Pharmaceutical Education and Research). Additionally, several leading teaching hospitals are already seeking partnerships with ethicamatrix including Shree Venkateswara Institute of Medical Sciences (SVIMS) of Tirupati, in Andhra Pradesh. SVIMS is one of the two teaching hospitals in the state of Andra Pradesh to have received national status from the All India Institute of Medical Science (AIIMS).

About ethica Clinical Research Inc.
Founded in 2002, ethica Clinical Research Inc. is a contract research organization (CRO) that conducts all clinical phases of ethical research for new and innovative treatments on behalf of the pharmaceutical, biotechnology and natural health product industries. ethica provides a complete range of services from conceptualization of a clinical study design to managing research physicians, their staff, their data, and analysis of data. Under the leadership and vision of ethica’s President, Janice E. Parente, PhD, ethica has become one of Canada’s fastest-growing companies and a leader in clinical research participant protection.

About Matrix Group
Established in 1996, the multi-service, globally inclined Matrix Group began its operations in Hyderabad and currently is a market leader in various regions of India in the sectors of aquaculture, agricultural products, and infrastructure development. A host of highly qualified experts support the manufacturing and trading operations of the Group in India. Under the leadership of founder, Chairman and Managing Director Mr. Siva Prasad, the company has partnered with the global giant Cargill Animal Nutrition in its biosciences venture – Matrix BioSciences – and has supported Cargill’s initiation of Indian operations. The Matrix Group is privately held.

Media Contact: To arrange an interview, please contact Jean Walter at MaisonBrison, (514) 731-0000, or at jean@maisonbrison.com.

Source: BioQuebec.com