Relentlessly identifying every action possible to help reduce the patients’ wait for your therapy.

With Heart

Our 1000+ strong consulting team includes ~100 former regulators/HTA assessors, alongside industry luminaries, who know exactly how to help you navigate regulatory and access hurdles to reach patients sooner.

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EBOOK

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Four strategies for oncology drug development in a post-COVID world

COVID-19 has changed every aspect of drug development. From novel endpoints to the advanced adoption of real-world evidence to decentralized trial designs, Parexel's experts and one insightful patient explore what new imperatives oncology drug developers can adopt to speed life-changing therapies to patients in need.

  • Incorporating novel surrogate endpoints
  • Leveraging external / synthetic control arms
  • Patient insights for oncology trial design
  • Benefits of demonstrating value earlier

Expert insights

eBook

Fulfilling the promise: Strategies for cell and gene therapies

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Panel discussion

Can external control arms address regulator and HTA evidence requirements?

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Podcast

Investing in the future of infectious disease vaccine development

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Regulatory & Access Content

Three ways to improve your chances that insurers will pay for a new CGT

Three ways to improve your chances that insurers will pay for a new CGT

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Four reasons to conduct robust natural history studies before clinical trials

Four reasons to conduct robust natural history studies before clinical trials

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We need faster endpoints for targeted cancer drugs, and there is one

We need faster endpoints for targeted cancer drugs, and there is one

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Strategies for working with global regulatory agencies

Strategies for working with global regulatory agencies

It’s never too early to start crafting a global regulatory submissions strategy. But while early engagement with regulatory authorities sounds like an obviously good thing to do, there are some potential pitfalls. In Parexel’s experience, the positives of early regulatory engagement outweigh the negatives. However, only for sponsors that are well-prepared.
 

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Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?

Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?

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Passionately guiding you through a regulatory and access environment they helped shape.

 

"With unrivaled real-world experience and a collective resume unlike any other team in the industry, our elite group can help you identify and navigate the requirements of regulators, providers, payers and patients holistically, and early. So you can get your innovation from the lab to the people who need it most, faster – with heart."

Paul Bridges
Senior Vice President and Worldwide Head of Regulatory & Access, Parexel 

 

Unrivaled real-world expertise includes:

  • 1000+ strong consulting team with ~100 former regulators and HTA assessors
  • Localized knowledge covering 110 countries
  • Therapeutic experts with deep technical expertise
  • Market access specialists with proven health technology assessment (HTA) success

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