Parexel Blog

Parexel Blog

  • Leveraging the draft FDA Guidance on PBPK for your drug development program

    Leveraging the draft FDA Guidance on PBPK for your drug development program

    In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics...

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  • We need faster endpoints for targeted cancer drugs, and there is one

    We need faster endpoints for targeted cancer drugs, and there is one

    As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...

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  • Three ways to improve your chances that insurers will pay for a new CGT

    Three ways to improve your chances that insurers will pay for a new CGT

    When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

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  • The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

    The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

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  • How market exclusivities can affect your development program

    How market exclusivities can affect your development program

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  • Regulatory considerations from former FDA regulators

    Regulatory considerations from former FDA regulators

    In this infographic, we’ve compiled some common questions our ex-FDA experts get asked, along with their perspectives.

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  • Creating an effective cell or gene therapy communications strategy

    Creating an effective cell or gene therapy communications strategy

    In this infographic, we have outlined some engagement activities that can enhance your cell or gene therapy development and inspire your stakeholders.

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  • Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives

    Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives

    Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by...

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  • Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights

    Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights

    Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet...

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  • Challenges of 2020: Lessons for Clinical Trials in Diabetes

    Challenges of 2020: Lessons for Clinical Trials in Diabetes

    The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the...

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  • Fostering steady advances in data operations: FSP partnerships can spur and support change

    Fostering steady advances in data operations: FSP partnerships can spur and support change

    When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...

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  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Virtual meetings are easy, right?

    Virtual meetings are easy, right?

    Recommendations for navigating the "new normal" and how to prepare for the future.

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  • Optimizing SOPS in the Digital World

    Optimizing SOPS in the Digital World

    For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...

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  • Five points to remember if FDA issues a Form 483

    Five points to remember if FDA issues a Form 483

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  • 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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  • 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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