Parexel Blog

Parexel Blog

  • The impact of COVID-19 on clinical trials in rare disease and oncology

    The impact of COVID-19 on clinical trials in rare disease and oncology

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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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  • An overview of the recent Executive Order on Critical Drugs Made in America

    An overview of the recent Executive Order on Critical Drugs Made in America

    On August 6, 2020 the president of the United States signed an Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The...

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  • Successful wearable device selection for the evolving clinical trials landscape

    Successful wearable device selection for the evolving clinical trials landscape

    There are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors...

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  • The Move Toward Global Standards: Navigating New EAEU Guidelines

    The Move Toward Global Standards: Navigating New EAEU Guidelines

    As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...

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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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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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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”

    As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

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  • Will the FDA “CARE” More About Your Supply Chain?

    Will the FDA “CARE” More About Your Supply Chain?

    On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...

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  • Has EMA started a domino effect for more regulation of API manufacturing?

    Has EMA started a domino effect for more regulation of API manufacturing?

    On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...

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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

    Decentralized clinical trials (DCT) had already begun to gain momentum, and the pandemic has dramatically accelerated their adoption. Enabling patients to participate in clinic trials from home is...

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  • Case Study: Parexel® Medical Imaging Supports AbbVie’s Elagolix

    Recently, Parexel supported a Phase III study of AbbVie’s Elagolix, a uterine fibroid treatment, that incorporated four complex medical imaging modalities utilized by investigative sites.

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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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  • 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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  • Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to...

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  • Becoming Proud

    Becoming Proud

    To help celebrate Pride month, Parexel's Simon Fleming shares the story of his career and life journey.

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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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