South Africa has a treatment naïve and generically diverse population which makes it easier for contract research organisations (CRO) to quickly recruit patients for clinical trials. Parexel has recognised and benefited from this, leading to it adding a third early phase unit in the country.
The new site in Port Elizabeth brings Parexel’s global early phase capacity, including the two other South African units in Bloemfontein and George, to 580 beds. Parexel believes this is among the largest early phase capacities in the world.
At the Port Elizabeth site Parexel will conduct early phase studies in patients, from first in man to proof of concept. This is the core focus of the unit but it will also conduct a variety of studies on healthy volunteers.
Patients and healthy volunteers will be recruited using the tools and techniques Parexel deploys at its SuperSites. These include using dedicated patient recruitment specialists, building relationships with local health care professionals and drawing on its database.
Fast recruitment is generally welcomed because of its positive impact on drug development timelines, an important issue for pharma and biotech, but Parexel believes there are additional benefits.
"Increasing the number of patients per site and reducing the overall number of sites in a study serves to decrease variability--improving study quality and reproducibility", explained Michelle Middle, corporate vice president and worldwide head of early phase at Parexel.
The Port Elizabeth unit will be integrated into Parexel’s early phase network, which spans three continents, by using harmonised systems that help handle complex global studies.