Speaking to Outsourcing-Pharma Adam Chasse, global head of Prime Sites at Quintiles, explained that there are lots of inefficiencies in the clinical trial process and improvements need to be made.
To tackle these problems Quintiles launched its Prime Site programme, which began in London, UK two years ago and since then has been expanded to Washington, US and now Pretoria, South Africa.
At these sites Quintiles uses its expertise in conjunction with their trusted partner to ensure that operations run in an efficient manner and to high standards.
Chasse explained that the clinical research industry generally lets trial sites figure out administrative and recruitment processes on their own but Quintiles believes there are benefits to being more proactive.
Inefficiencies in the administrative processes, in particular assessing study feasibility and regulatory delays, can slow processes at some centres and Quintiles is attempting to improve on this at its Prime Sites.
Furthermore, Quintiles is applying its knowledge of best practices to recruitment, which is an area where inefficiencies can arise from difficulties in identifying patients and discussing clinical trials as a treatment option, including appropriate explanation of benefits and risks.
This is partially overcome by establishing Prime Sites at large clinical centres big patient population. Furthermore, the sites are capable of operating in a diverse range of therapeutic fields but there are additional factors, according to Chasse.
In particular he highlighted the importance of the Prime Site having a large number of clinicians interested in conducting trials, which is one of the reasons Quintiles selected the University of Pretoria, South Africa for its recent expansion.
In addition Quintiles’ experience in South Africa was a factor. Chasse explained that Quintiles has gained a good understanding of the nation’s regulatory programmes and consequently administrative start up is quicker and less onerous, while still maintaining high standards.
Improve & expand
Having launched three Prime Sites in the past two years Quintiles is looking at all geographies, with Asia, Latin America and Central & Eastern Europe being mentioned in a press statement, for its next expansion.
However, Chasse explained that Quintiles is also keen to build upon progress at the existing sites. Projects at the initial two sites have increased, with 28 different drugs being tested in 2009, and consequently Quintiles is aiming to implement long-term strategic initiatives.
Chasse added that the Prime Site programme is still in its early-stages but that pharma has been impressed by the leadership shown by Quintiles in establishing the operation.