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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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  • Navigating the new normal for meetings – now and for the future

    Navigating the new normal for meetings – now and for the future

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  • See Parexel's latest COVID-19 expert content

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  • The long and winding road for quality metrics takes another turn

    The long and winding road for quality metrics takes another turn

    In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

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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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  • Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

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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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  • 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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  • How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

    How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

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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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  • How to interact virtually with health authorities

    How to interact virtually with health authorities

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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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  • Will the FDA “CARE” More About Your Supply Chain?

    Will the FDA “CARE” More About Your Supply Chain?

    On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...

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  • Has EMA started a domino effect for more regulation of API manufacturing?

    Has EMA started a domino effect for more regulation of API manufacturing?

    On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...

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  • What’s Around the Corner for FDA Inspections?

    What’s Around the Corner for FDA Inspections?

    There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...

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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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