Phase IIa, proof of concept

Patient recruitment success

As a CRO of distinction, you expect PAREXEL to deliver expertise, added scientific value, high quality data and superior service. What you might not expect from early phase clinical units is access to a high number of patient populations for early phase patient studies and proof of concept studies performed in-house. In fact, for a long time PAREXEL Early Phase has developed patient databases and strategically chosen locations for accelerated patient access. We expected demand for in-house early phase patient studies to increase, understanding your need to get safety and efficacy data in patients sooner. See some of our case studies demonstrating our in-house patient recruitment abilities.

Dedicated proof of concept services

In addition to the patient studies PAREXEL routinely performs in-house through our Phase I units, we are able to offer our clients dedicated support for proof of concept studies. PAREXEL’s proof of concept unit integrates expertise and capabilities in regulatory strategies, drug development, and clinical pharmacology. 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 broader 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.