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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n 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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In this article, Parexel regulatory outsourcing experts explore five competencies companies can use to manage post-marketing regulatory requirements better and more efficiently.
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Parexel experts have compiled some lessons learned and share recommendations on how companies can be more effective at collecting RWD and generating RWE in different regions
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Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.
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This article summarizes a recent panel discussion where experts from Parexel and biotech company, MorphoSys, shared their experiences from recent pioneering efforts in RWE.
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Learn how all stakeholders benefit when patients and their insights are at the heart of every aspect of clinical development.
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Patients’ needs and insights are central to how we design and conduct trials. Here are our top ten rules for a successful DCT...
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