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.

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