Phase IIa, Proof of Concept

PAREXEL® provides dedicated support for Proof of Concept studies. Our Proof of Concept unit integrates expertise and capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof of Concept studies are mainly conducted in targeted patient populations and are designed to demonstrate early signals of a product’s efficacy. Our goal of these studies is to help you avoid costly late stage clinical development failures by making better and faster go/no-go decisions.

PAREXEL’s dedicated team of experts provides you with the required scientific, therapeutic, and regulatory expertise to design and implement Proof of Concept studies for new drug entities across a broad range of therapeutic indications. This team offers customized solutions including the appropriate use of biomarkers and adaptive trial designs. Adaptive designs are supported by specialized biostatistical expertise and eClinical technology capabilities. Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory as well as electronic data capture to provide rapid access to study data.

To accelerate patient recruitment, our Proof of Concept service offering provides PAREXEL SuperSitesSM capabilities in combination with a broad, global network of investigator and academic sites. PAREXEL SuperSites solutions leverage PAREXEL’s hospital-based Clinical Pharmacology Research Units to provide high patient enrollment potential. This allows for a high number of patients to be recruited in a shorter time frame, reducing the overall number of investigator sites, and ultimately decreasing time and cost.

Key Materials


Starting Stronger in Phase I Through IIa

Learn how our Early Phase services can add value from first-in-human through proof-of-concept. Download our brochure to learn more.


Medical Imaging Services

Learn how the use of novel imaging approaches early in the clinical development process can help you achieve savings in timelines and resources. Download Now

The Changing Face of the Early Phase Volunteer

What "learn and confirm" paradigm means for patients,early phase clinical trials

Download a copy of the article from the March 17, 2014 issue of Executive Insight and learn about the future of early phase clinical studies. 


Clinical PK/PD & Pharmacometrics Services

Establish your best protocol-saving you time and money-with our PK/PD and Pharmacometrics Services.