Parexel's COVID-19 expert content

  • 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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  • Biosimilars in the time of COVID-19 and beyond

    Biosimilars in the time of COVID-19 and beyond

    Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

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  • Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...

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  • Managing Continuity in Clinical Trials in the COVID-19 environment:  The Decentralized Option and Regulatory Flexibility

    Managing Continuity in Clinical Trials in the COVID-19 environment: The Decentralized Option and Regulatory Flexibility

    Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...

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  • Desk-based Health Authority inspections: A risk-based approach to compliance

    Desk-based Health Authority inspections: A risk-based approach to compliance

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  • Vendor Audits and cGMPs

    Vendor Audits and cGMPs

    Industries are taking ongoing actions in their response efforts to COVID-19 and this includes being prepared for Regulatory Authority CGMP requirements which include Vendor Audits. FDA through...

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  • Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

    Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

    The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...

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  • The Parexel Podcast | Episode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective

    The Parexel Podcast | Episode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective

    Now more than ever it's important to recognize and show our appreciation for clinical trials and the critical role that they play in advancing public health. Since the outbreak of the COVID-19...

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  • COVID-19 Impact on Rare Disease Patients and Manufacturers

    COVID-19 Impact on Rare Disease Patients and Manufacturers

    About the Authors Yi Liu, PhD is a Senior Analyst in the Health...

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  • Protective Antibody Therapy: Preventing Future COVID-19 Outbreaks

    Protective Antibody Therapy: Preventing Future COVID-19 Outbreaks

    About the Authors Dean Giovanniello, RPh., Vice President, co-leads the Health Advances Biopharma...

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  • COVID-19: Gastrointestinal and hepatic manifestations and implications for clinical trials

    COVID-19: Gastrointestinal and hepatic manifestations and implications for clinical trials

    Parexel expert Michelle Pietzak, MD reviews current findings and offers practical recommendations for gastrointestinal symptoms of COVID-19 and considerations for clinical trials.

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