Parexel's COVID-19 expert content

  • How COVID-19 Testing Demand Threw off Thermo Fisher’s Acquisition of Qiagen

    How COVID-19 Testing Demand Threw off Thermo Fisher’s Acquisition of Qiagen

    About the Authors Aaron Dy, Ph.D. is a Senior Analyst in the Health Advances...

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  • I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...

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  • Biopharma R&D in the Post-COVID World

    Biopharma R&D in the Post-COVID World

    About the Authors Steven Chang, Ph.D. is a Senior Analyst in the Health...

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  • eBook: Biopharma in the COVID-19 World

    eBook: Biopharma in the COVID-19 World

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  • The Special Approval Pathway (SAP) for COVID-19 related products in China

    The Special Approval Pathway (SAP) for COVID-19 related products in China

    The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

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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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  • Against All Odds: Can Covid-19 Usher in a New Era in International Public Health Cooperation?

    Against All Odds: Can Covid-19 Usher in a New Era in International Public Health Cooperation?

    Key Takeaways The COVID-19 pandemic has drawn attention to international efforts to promote...

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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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  • Demystifying SARS-CoV-2 Testing for COVID-19 (Third Edition – Part 1: Updates and Trends)

    Demystifying SARS-CoV-2 Testing for COVID-19 (Third Edition – Part 1: Updates and Trends)

    Click here to download the full presentation. SummaryAs the world continues to battle...

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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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  • An opportunity in a time of crisis: COVID-19 and the new pragmatism

    An opportunity in a time of crisis: COVID-19 and the new pragmatism

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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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  • eBook: Digital Health and the Global Pandemic

    eBook: Digital Health and the Global Pandemic

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  • EMA Guidance: Management of Clinical Trials - What it means for Patients?

    EMA Guidance: Management of Clinical Trials - What it means for Patients?

    A lay summary for patients participating in clinical trials

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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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  • SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

    SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

    About the Authors Saakshi Chadha, PhD is a Senior Analyst in the Health...

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  • Keeping ahead of the regulatory curve – Stay open for business

    Keeping ahead of the regulatory curve – Stay open for business

    On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified...

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  • COVID-19: Digestive symptoms of the novel virus and implications for clinical trials

    COVID-19: Digestive symptoms of the novel virus and implications for clinical trials

    As the entire healthcare ecosystem grapples with the COVID-19 virus, more evidence surfaces every day of manifestations beyond fever, respiratory symptoms and fatigue. In fact, a recent...

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  • Navigating new steps in how FDA is managing COVID-19 Products

    Navigating new steps in how FDA is managing COVID-19 Products

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