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  • The impact of COVID-19 on clinical trials in rare disease and oncology

    The impact of COVID-19 on clinical trials in rare disease and oncology

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

    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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  • How market exclusivities can affect your development program

    How market exclusivities can affect your development program

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  • See Parexel's latest COVID-19 expert content

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  • 3 ways to reap the benefits of adaptive-trials

    3 ways to reap the benefits of adaptive-trials

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  • Parexel on the pulse2:08

    Parexel on the pulse

    Parexel regulatory expert, Mark Birse, gives an update on BREXIT.

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  • Patient engagement: Being heard3:04

    Patient engagement: Being heard

    Parexel has a heartfelt conversation with Lennie & Denny Woods, Parents & Co-Founders of Sara’s Cure (https://sarascure.org/), of their daily fight to find a cure for Clear Cell Sarcoma.

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  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Virtual meetings are easy, right?

    Virtual meetings are easy, right?

    Recommendations for navigating the "new normal" and how to prepare for the future.

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  • Parexel on the Pulse1:49

    Parexel on the Pulse

    Paul Bridges on the EU Clinical Trial Regulation (CTR)

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  • Five points to remember if FDA issues a Form 483

    Five points to remember if FDA issues a Form 483

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  • When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases

    When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases

    About the Authors Mansi Shinde, Ph.D. is an Engagement Manager based in the...

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  • Hong Kong Exchange: Nurturing China’s Biotech Valley

    Hong Kong Exchange: Nurturing China’s Biotech Valley

    About the Authors Daniel Huang is an Analyst based in the Hong Kong...

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  • eBook: Biopharma in the COVID-19 World

    eBook: Biopharma in the COVID-19 World

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  • NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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  • GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

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  • FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

    FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

    Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices.  Numerous...

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  • Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

    Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

    During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...

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  • Putting the Pandemic in Plain Language

    Putting the Pandemic in Plain Language

    The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...

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