Phase IIIb-IV

Clearing the market access hurdle.

Late phase is an exciting stage of your clinical development as it 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.

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Webinar

Successfully Integrating EHR and EDC Data: Putting the 'Real' in Real-World Evidence

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Covid-19 Health Authority Updates

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Desk-based Health Authority inspections: A risk-based approach to compliance

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Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

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We are always available for a conversation.

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