Article from December 2021 edition of Applied Clinical Trials. Parexel regulatory experts offer top tips for working with regulators on a global scale.
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Parexel CEO, Jamie Macdonald, discusses how the pandemic accelerated and changed the industry, and emerging industry trends driving growth in 2022
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Articulating a coherent product value story from the start of development can help companies attract investors.
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The shortcomings of traditional study designs have come into sharp relief during the COVID-19 pandemic. Regulatory agencies and the research community alike have responded, acknowledging the need...
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Stephanie Gonzalez, VP and Head of Biotech Operations for EMEA, compares preparation for competing in triathlon with planning for clinical trials, and the importance of being prepared for what's ahead
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...
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In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.
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In a two-part series, this second paper discusses driving RBQM adoption and what an effective RBQM change management program looks like.
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Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"
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Natalia Grassis, Corporate Vice President and Head of Biotech Operations for the Americas, talks about her passion for the work we do to make a difference in patients' lives.
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Skip Sands, SVP and Senior Medical Officer of Parexel Biotech, discusses practical examples of how to build and maintain a relationship based on mutual trust
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In this infographic, we outline three ways to incorporate Diversity, Equity and Inclusion into your strategy to deliver inclusive communications that connect with a diverse and multicultural audience
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Well before the COVID-19 pandemic struck in early 2020, drug developers were struggling to become more efficient. At industry conferences, executives, regulators, and investigators lauded new...
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In a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance for emerging ICH core guidances on RBQM
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Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.
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Kate Bertolet, Chief of Staff for Parexel Biotech operations, talks about motivating her study teams and the drive to meet the unmet needs of the patients.
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A rare disease — and a part-time job — showed Lisa Dilworth what she was meant to do.
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During the twenty years I served as a chief medical officer for small and emerging biotech firms, selecting the right contract research organization (CRO) was one of the most important decisions I...
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Useful practices for getting the most out of your collaboration the FDA
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COVID-19 led to an era of remarkable regulatory flexibility and innovation with Decentralized Clinical Trial (DCT) strategies and tools but are they here to stay? Read more in this article.
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