Parexel Blog

Parexel Blog

  • The Parexel Podcast | Episode 8: Performing clinical trials in a shifting development landscape

    The Parexel Podcast | Episode 8: Performing clinical trials in a shifting development landscape

    The COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks...

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  • Part 2: Navigating Patient Privacy During Remote Monitoring in the Age of COVID-19

    Part 2: Navigating Patient Privacy During Remote Monitoring in the Age of COVID-19

    Following on from part 1,  I addressed how to maintain patient privacy in the COVID-19 pandemic. In this blog, I’ll take a deeper look at the use of Remote (Central) Monitoring. Remote (or...

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  • Part 1: Navigating Patient Privacy During Remote Monitoring in the Age of COVID-19

    Part 1: Navigating Patient Privacy During Remote Monitoring in the Age of COVID-19

    Patient Privacy Patient Privacy is a mainstay of clinical trials and is incorporated into the International Council on Harmonization (ICH) E6 (R2) Good Clinical Practices (GCP) guideline1. ...

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  • Perspective on the FDA enforcement policy for ventilators, accessories and other respiratory devices during COVID-19

    Perspective on the FDA enforcement policy for ventilators, accessories and other respiratory devices during COVID-19

    Background  There is an insufficient supply of ventilators to treat patients around the globe desperately in need of ventilatory support due to the Coronavirus pandemic. In response to the...

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  • FDA Launches Coronavirus Treatment Acceleration Program (CTAP)

    FDA Launches Coronavirus Treatment Acceleration Program (CTAP)

    To provide structure and context to the measures the Food and Drug Administration (FDA) is taking to accelerate the review and availability of treatments for COVID-19, the Agency announced a...

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  • Virus Filtration: a key manufacturing step keeping medicines safe, including from emerging viruses like COVID-19

    Virus Filtration: a key manufacturing step keeping medicines safe, including from emerging viruses like COVID-19

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  • Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

    Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

    In summary FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical...

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  • New global frameworks for managing clinical trials during COVID-19 emergency

    New global frameworks for managing clinical trials during COVID-19 emergency

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  • New version 2 “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” published on European Commission we

    New version 2 “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” published on European Commission we

    After only one week since publishing of the first version on 20-Mar-2020, an updated version 2 of “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” has...

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  • New global frameworks for managing clinical trials during COVID-19 emergency

    New global frameworks for managing clinical trials during COVID-19 emergency

    As global health authorities react and adjust to responding to the emerging COVID-19 threat to public health, one of the results has been more guidance, published much more often and without going...

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  • Where do we stand with COVID-19?

    Where do we stand with COVID-19?

      Since the first case of coronavirus (COVID-19) was identified in December 2019, cases have been confirmed on every continent but Antarctica, prompting the World Health Organization to declare...

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  • Back to the future – Are you prepared to meet unprecedented demand to use old drugs for new purposes?

    Back to the future – Are you prepared to meet unprecedented demand to use old drugs for new purposes?

    There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on...

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  • COVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions

    COVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions

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  • Perspective on Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

    Perspective on Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

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  • COVID-19: Regulatory Impact

    COVID-19: Regulatory Impact

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  • FDA takes action to accelerate availability of COVID-19 diagnostic tests

    FDA takes action to accelerate availability of COVID-19 diagnostic tests

    On February 29, 2020, the U.S Food and Drug Administration (FDA) published an “immediately in effect guidance” that is designed to directly address the acute shortage of diagnostic tests currently...

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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

    Increasingly over the last 10 years global regulators have looked to see how a greater reliance on desk-based inspection activities can support their surveillance programs.  This approach can be...

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  • Safer Technologies Program for Medical Devices (STeP): Initial Impressions

    Safer Technologies Program for Medical Devices (STeP): Initial Impressions

    On September 19, 2019, the FDA issued a draft guidance on the Safer Technologies Program for Medical Devices (STeP), which was created as a complement to the Breakthrough Devices Program. Similar...

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  • COVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives

    COVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives

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  • Solutions for sustainable supply chains in a period of global tumult

    Solutions for sustainable supply chains in a period of global tumult

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