Phase IIIb & Phase IV Clinical Trials

Guiding you through the home stretch.

To take you through the final push to commercialization, we’re committed to getting the details just right. Parexel's late phase specialists take care to tailor scientific, strategic, and market solutions to your situation and your people.

We give your Phase IIIb and IV operations a sound network with our global infrastructure, multi-disciplinary experience, and the latest in integrated technologies. And when the time comes to bring your new therapy to market, we’re right there to develop a market strategy that will build value quickly – all while closely monitoring long-term effects and safety.

We are proud to provide:

• Dedicated project management staff with global and local late phase understanding
• Global presence with local market presence to customize solutions
• Focused site management and worldwide remote monitoring capacity to manage costs
• Integrated technologies that optimize data flow, trial management, and reporting

Clearing the market access hurdle.

Late phase clinical studies are an exciting stages in clinical development as your drug or device transitions from testing to commercialization. Marketing authorization is in progress , and we’re ready to help you connect the dots and sustain momentum. Stakeholders including regulators, payers, physicians, and patients all need to be satisfied that your drug or device is safe, effective, and offers greater value or benefit than current standard of care. Parexel’s Regulatory & Access consulting organization – an elite team of 1000+ consultants help clients chart the best, most-efficient, course through global regulatory, market access and commercial hurdles.

We’ve integrated regulatory and market access expertise to provide a source of disruptive innovation for clients looking for competitive advantage across every step of their development programs. Our Regulatory & Access consulting organization includes ~100 former regulators and HTA assessors to share innovative thinking, and practical, actionable insights. Because they wrote the guidance yesterday, our consultants know exactly how to interpret it today to give you a strategic advantage.

Parexel’s Real-World Evidence (RWE) experts help companies explore the impact of a therapy and/or disease in a real-world setting and generate real-world data that can support your proposition to regulators, payers, physicians and patients. We understand the need for interconnected, patient-specific that's longitudinal in order to track outcomes over time, and we are helping many companies solve this challenge including with the use of hybrid prospective/retrospective RWE studies.