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New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

David Brown, Global Head of Epidemiology, summarizes the three FDA guidances related to data sources, data standards, and regulatory considerations in RWE/RWD and benefits of early engagement.

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Communicating Value to Providers and Payers

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Early planning can help you make the most of expedited regulatory pathways

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How biotechs can strengthen their value story with advanced analytics

Read five ways biotech companies can enhance their value story with advanced analytics.

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Pragmatic Trials: Targeting evidence generation to inform market access and meet payers’ needs

For payment systems to evolve to deal with reimbursement and market access challenges, payers are taking a new look at evidence generation and data usage. Read how pragmatic trials can help >

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New endpoints for early-stage cancer are gaining regulatory traction

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Five lessons for building an external control arm that regulators can use

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How emerging biotechs can enter the Chinese market and prosper

In this article, Parexel experts outline five approaches that foreign companies with limited resources should use to gain a foothold in the Chinese market.

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Making Expedited Regulatory Pathways Work for Global Drug Development Programs

Article from December 2021 edition of Applied Clinical Trials. Parexel regulatory experts offer top tips for working with regulators on a global scale.

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Three strategies for articulating a coherent product value story

Articulating a coherent product value story from the start of development can help companies attract investors.

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Biosimilar Development: Are therapeutic clinical trials needed?

In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.

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Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"

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What to know about FDA INTERACT meetings

Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.

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Three ways to work with the FDA for better patient-focused trials

Useful practices for getting the most out of your collaboration the FDA

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Maximize the efficiency of regulatory operations with five key competencies

In this article, Parexel regulatory outsourcing experts explore five competencies companies can use to manage post-marketing regulatory requirements better and more efficiently.

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Four reasons to conduct robust natural history studies before clinical trials

Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.

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The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...

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Five competencies for operational excellence in cell and gene therapy clinical trials

What is different about cell & gene therapy trials, and what does it take to operationalize them effectively? We break it down into five competencies you need for success.

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

When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

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How market exclusivities can affect your development program

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