COVID-19

  • COVID19 The Great Decentralized Clinical Trials Accelerator

    COVID19 The Great Decentralized Clinical Trials Accelerator

    Learn more from Roz Round, Parexel’s Vice President, Patient Innovation Center about how Decentralized Clinical Trials can help ensure patient safety and enable ongoing trial participation.

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  • COVID-19 HEALTH AUTHORITY UPDATES 18 DECEMBER 2020

    COVID-19 HEALTH AUTHORITY UPDATES 18 DECEMBER 2020

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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

    FDA has previously made several public statements about its ability to conduct inspections and FDA personnel have also made policy comments in various public forums. Now that this guidance has...

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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

    Since the COVID-19 pandemic began in early 2020, the Center for Drug Evaluation (CDE) has maximized its capacity and optimized its regulatory procedures within the SAP framework to accelerate...

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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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  • 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”

    With the continued threat of COVID-19, the way inspections will be performed and hosted will be significantly different from the pre-pandemic situation.

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  • The future is now: Decentralized clinical trials during the pandemic and beyond

    The future is now: Decentralized clinical trials during the pandemic and beyond

    Enabling patients to participate in clinic trials from home is both important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for COVID-19.

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  • FSP and COVID-19: Impact on Clinical Trial Development

    FSP and COVID-19: Impact on Clinical Trial Development

    The functional service provider (FSP) outsourcing model enables sponsors to efficiently and cost-effectively manage workforce needs across clinical portfolios. FSP models proved to be a strategic...

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  • COVID-19 and the new pragmatism

    COVID-19 and the new pragmatism

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  • Critical Global Pandemic Safety Considerations: FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with C

    Critical Global Pandemic Safety Considerations: FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with C

    On June 19, 2020, FDA released a Guidance for Industry (GFI) entitled Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products...

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  • COVID-19 Lay Summary EMA Management of Clinical Trials

    COVID-19 Lay Summary EMA Management of 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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  • COVID-19 Lay Summary-FDA Conduct of Clinical Trials

    COVID-19 Lay Summary-FDA Conduct of Clinical Trials

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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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  • 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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  • 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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  • 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

    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 and the Impact on Pediatric Clinical Trials

    COVID-19 and the Impact on Pediatric Clinical Trials

    The COVID-19 global pandemic has had a significant impact on the conduct of pediatric and adult clinical drug trials. Many trials have halted enrollment, and there are multiple challenges with...

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