17 Sep 2012, BioSpectrum Bureau , BioSpectrum
Bangalore: The Association for the Accreditation of Human Research Protection Programs, announced that it has accredited a third organization in India, Jehangir Clinical Development Center (JCDC) in Pune, and a second contract research organization, (CRO) Celerion, headquartered in Nebraska.
The accreditations are the latest indication that organizations are embracing AAHRPP's goal of one set of standards worldwide for CROs, independent institutional review boards, research-intensive universities, medical colleges, hospitals, and other entities engaged in research involving human participants.
Inroads in critical markets
India is among the fastest growing markets for clinical trials. However, growth has also brought calls for stronger research protections and greater emphasis on research quality. As in the US, organizations increasingly are answering that call by seeking AAHRPP accreditation.
"By earning AAHRPP accreditation, Jehangir Clinical Development Centre has taken the lead in demonstrating a commitment to safe, ethical research," said Dr Marjorie A Speers, AAHRPP president and CEO. "Like its AAHRPP-accredited peers in the United States and India, Jehangir Clinical Development Centre has earned a place among some of the world's most respected research organizations."
In fact, to attain AAHRPP accreditation, JCDC had to show compliance with both India's requirements for research protections and US regulations.
Even before attaining AAHRPP accreditation, JCDC had taken steps to differentiate itself from other entities in India.
"At JCDC, we set up a research center, built the infrastructure, and committed the resources necessary for a quality research program," said JCDC CEO, Mr Pathik Divate. "We viewed AAHRPP accreditation as the logical step to take our program to the next level-for research participant protection, standardization, and quality. We've also sent a message to the rest of the research institutes," he added. "If they're serious about clinical research, they should be thinking about AAHRPP accreditation."
The accreditation of Celerion's clinical facilities in Lincoln and Neptune represents a similar milestone. Celerion is the second CRO, and the first headquartered in the US, to earn AAHRPP accreditation. CRO accreditations are particularly important because these organizations typically oversee the higher-risk phase 1 clinical trials.
"The AAHRPP accreditation demonstrates the leadership role Celerion has taken to reach the highest standards and protections for human participants in our clinical studies," said Dr Susan Thornton, president and CEO, Celerion. "This accreditation also highlights our commitment to increased quality and transparency in conducting ethically sound research for our clients."
Speers praised Celerion for setting an example and raising the bar for research protections among CROs. "With AAHRPP accreditation, Celerion now offers a level of quality assurance that distinguishes it among CROs and boosts its appeal to research sponsors," she said. "Our hope is that Celerion's decision has a ripple effect across the research enterprise and that other CROs follow suit."
AAHRPP accreditation is available to US and international organizations that conduct biomedical, behavioral or social sciences research involving human participants. AAHRPP already has accredited organizations in 46 states, Canada, China, India, Korea and Singapore.