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+1 617 454 9300
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+1 919 544 3170
© 2000-2021. Parexel International Corporation.
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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FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
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COVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development
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COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials
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Part Two: The Unique Impact of COVID-19 and Implications for the MSK Industry
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The Great Lockdown of 2020: Will the Life Sciences Emerge Unscathed?
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Rapid Responders: How Innovative Technologies are Accelerating Development of New Vaccines
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Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
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Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
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CAR-T: How far have we come and where are we going?
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Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations
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Episode 4: Accelerated Regulatory Pathways and Patient Access
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Reimagining the Global Value Dossier - Part 4
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Capturing the patient voice in market access communications
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We are always available for a conversation.