The new unit integrates expertise and capabilities in regulatory strategies, drug development, and clinical pharmacology, said the firm in a statement.
Proof of Concept studies are mainly conducted in targeted patient populations and are designed to demonstrate early signals of a product's efficacy, according to Parexel.
“The goal of these studies is to help clients avoid costly late stage clinical development failures by making better and faster go/no-go decisions,” it said.
Providing clients with integrated, early phase development strategies and expertise gives them the ability to support early identification and selection of the most promising compounds, said Herman Scholtz, Parexel’s corporate vice president, early drug development.
The service will cover all aspects of trial design and execution, including the appropriate use of biomarkers and adaptive trial designs, interactive voice and web response systems (IVRS/IWRS) to randomise patients and track drug inventory as well as electronic data capture (EDC) to provide rapid access to study data. Parexel recently boosted its offerings in the latter area via it purchase of eClinical specialist Clinphone.
Parexel is not alone in pushing its early-stage development business, with other CRPs such as Kendle and Covance also boosting their capacities in this area in recent months.
There has been a significant increase in demand for this type of trial on the back of a boom in the number of drugs entering the early-stage development pipeline – particularly from smaller pharmaceutical and biopharmaceutical companies - and concerns that CROs do not have the capacity to meet it.
Parexel has been expanding to meet this demand, and in March bolstered its early-stage capacity with the expansion of its clinical pharmacology units in Baltimore, Maryland in the US; London, UK; and Berlin, Germany.
The new proof of concept unit will also tap into Parexel’s SuperSites network of investigator and academic sites, which accelerates recruitment of patients into trials, said the company.