By Deb Borfitz
January 19, 2010 | Quintiles has been quietly but diligently working with a few investigative sites on three continents—one each in the United Kingdom, United States, and South Africa—to improve the output of clinical research. These Prime Sites, as Quintiles has termed them, are focused on rooting out operational inefficiencies while creating the infrastructure necessary to expand into new therapeutic areas.
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| Adam Chasse |
The initiative began more than two years ago at the University of London’s Queen Mary College and expanded to Washington (DC) Hospital Center in 2008 and the University of Pretoria last July, says Adam Chasse, global head of Prime Sites at Quintiles. The sites are all large institutions with a sizeable patient population and high proportion of physicians potentially or actively engaged in clinical research. They also share Quintiles’ vision about the role of clinical research within their respective organization.Institutional management at each Prime Site understands that a sustainable research program is about more than increasing revenues, says Chasse. It’s about establishing the right standard operating procedures and quality administrative processes to ensure that patients are well taken care of amidst rapid growth. Given that mindset, Quintiles believes it will ultimately be able to place 40 or more studies annually at these locations.
The geographic appeal of South Africa is its top-notch health care capabilities and mix of First World and Third World disease prevalence, says Chasse. South Africa’s Medicine Control Council, the equivalent of the U.S. Food & Drug Administration, has also “streamlined its trial approvals over the past couple of years.” Study start-ups here take roughly six months, on par with most Western European countries.
The next Prime Sites could be “virtually anywhere,” dictated more by institutional interest and potential than geographic targets, says Chasse. “We expect to have several more [Prime Sites] over the next couple of years.”
Significantly more Quintiles work is happening at all three institutions since they became Prime Sites, “enough to keep one person on each side fully busy managing the partnership,” says Chasse. The alliance manager at Quintiles ensures all appropriate studies are offered to the Prime Sites and the right people talk to each other to come up with a patient recruitment plan for studies, in addition to dealing with any impasses that occur during the study startup process. “The longer term objective is to increase the number of doctors doing research while ensuring highest quality.”
A big part of the alliance manager’s job is to examine all operational interactions for improvement opportunities, says Chasse. Quintiles and one its Prime Sites have cut study startup times in half, from six to three months, by developing workload management and escalation tools.
The partnership program is unique among clinical research organizations. In 2009, about 30 different drugs were tested through Quintiles studies at the Prime Sites, says Chasse.