Demonstrating product value to improve pharmaceutical licensing opportunities

The thousands of smaller, research-based biopharmaceutical companies performing much of today’s cutting-edge research face substantial challenges navigating the early stages of development to demonstrate the value of their novel therapies for potential pharmaceutical licensing partners or purchasers.  They need to provide key efficacy and safety data as quickly as possible, yet most of these companies lack the infrastructure and resources to undertake an extensive early-phase testing program.

Early phase pharmaceutical product development

PAREXEL is right where you need us to help meet those challenges and keep your early phase pharmaceutical product development moving forward quickly and efficiently. We have the experience and resources to guide you through every aspect of early phase development, including designing and performing designing robust trials, overcoming regulatory hurdles, managing data, and overseeing the entire early phase process. Utilizing our strategic network of early phase clinical units in the US, Europe, and South Africa, PAREXEL can provide individually tailored Phase I/IIa pharmaceutical product development programs across a wide spectrum of therapeutic areas. 

Proof of Concept clinical trials

We also have extensive experience conducting Proof of Concept (PoC) studies, which offer a faster, less-expensive way to test the therapeutic potential of a new product.  A typical Proof of Concept study is designed to find signals of a product’s efficacy against a targeted indication as soon as possible in the development process.  For smaller companies with limited resources, a Proof of Concept study can be the best approach to quickly answer key efficacy questions and demonstrate the value of their product to increase licensing opportunities.

PAREXEL’s other early phase capabilities include:

• Global database of healthy volunteers and patients
• Highly qualified investigators and sites
• Comprehensive technology resources
• Market analysis and product classification/positioning
• Strategic product development planning
• Regulatory liaison and pre-IND agency meetings
• Bioanalytical analysis
• IND preparation and submission
• Manufacturing process development and GMP auditing