First Canadian CRO to expand clinical trial management operations to
MONTREAL, Aug. 21 /CNW Telbec/ - 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.
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