Parexel Blog

Parexel Blog

  • Becoming Proud

    Becoming Proud

    I don’t have a great answer to the question, “when did you first know you were gay?” I simply cannot remember a time when I didn’t know. I do know, however, that it occupied a very negative part...

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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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  • Risk-Based Monitoring: The Right Solution for a Turbulent Present and an Uncertain Future

    Risk-Based Monitoring: The Right Solution for a Turbulent Present and an Uncertain Future

    Amidst the human tragedy of the current pandemic, clinical trials must go on as sponsors strive to develop and deliver life-saving treatments. While the impact of the pandemic on clinical trials...

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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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  • The Parexel Podcast | Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

    The Parexel Podcast | Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

    In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster,...

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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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  • 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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  • 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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  • 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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  • 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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  • The Parexel Podcast | Episode 10: The emerging role of wearables in clinical trials

    The Parexel Podcast | Episode 10: The emerging role of wearables in clinical trials

    The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs)....

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  • The Parexel Podcast | Episode 10: The emerging role of wearables in clinical trials

    The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs)....

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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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  • Considerations for protecting your business and employees from COVID-19

    Considerations for protecting your business and employees from COVID-19

    This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.

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