US-based contract research organisation (CRO) Parexel has launched a new early-phase development unit that will offer biopharmaceutical companies dedicated support for Proof of Concept studies.

The new unit integrates expertise and capabilities in regulatory strategies, drug development and clinical pharmacology across a broad range of therapeutic indications, Parexel said.

The aim of Proof of Concept studies is to obtain early signals of a drug’s efficacy, usually in targeted patient populations, and to help avoid costly late-stage development failures by making better and faster ‘go/no go’ decisions. A growing number of “complex and rigorous” Proof of Concept studies are being conducted as the biopharmaceutical industry explores new development paradigms to bring safe and effective treatments to market more efficiently, noted Dr Herman Scholtz, Parexel’s corporate vice-president, early drug development.

The Proof of Concept unit can provide customised solutions including appropriate use of biomarkers and adaptive trial designs, the latter backed up by specialised biostatistical expertise and eClinical technology capabilities such as Interactive Voice and Web Response Systems to randomise patients and track drug inventory, as well as rapid access to study data through electronic data capture. Parexel recently boosted its presence in the eClinical space by acquiring UK-based clinical technology specialist ClinPhone for £91 million (US$169.9 million).

The Proof of Concept offering also includes Parexel SuperSites capabilities, in combination with a global network of investigator and academic sites, to accelerate patient recruitment into trials. SuperSites solutions leverage Parexel’s hospital-based Clinical Pharmacology Research Units to recruit high volumes of patients at these sites in a shorter timeframe, drawing on dedicated recruitment specialists and relationships with local hospital-based physicians as well as on-site call centres and database capabilities, the CRO explained.

Parexel has been stepping up its commitment to early-phase clinical development, IN March the CRO announced that it had completed the expansion of three Clinical Pharmacology Research Units in Baltimore (US), London (UK) and Berlin (Germany).