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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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In this infographic, we share five tips for building an effective reimbursement strategy for your oncology product.
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We have created this guide to simplify the terminology of real-world evidence (RWE) and outline some of the strategic options available.
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Discover three key considerations for crafting a successful genomic biomarker strategy in this article.
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In this article, we summarize what we’ve learned and outline the top 10 rules for a successful DCT.
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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 risk management strategies for drug developers who wish to take full advantage of expedited pathways to achieve reimbursable innovation for the benefit of patients.
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Key findings from a recent discussion with Parexel regulatory experts and the rare disease patient advocacy group Sara’s Cure.
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Parexel experts discuss a recent project involving a Rare Disease Oncology therapeutic, in which our experts leveraged Real-world Evidence and FDA/Regulatory expertise to develop and execute a Synthet
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Parexel’s Rosamund Round, Director, Patient Innovation Center and Amy McKee, Vice President, Regulatory Consulting Services sit down with Monica Theis, a breast cancer survivor and two-time clinical t
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In this whitepaper, we address the unique variables, optimal timing, and immunogenic considerations for vaccinating individuals with cancer.
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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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Insights on regulatory and trial design considerations for drug development in oncology.
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Discover three key considerations for crafting a successful genomic biomarker strategy in this article.
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Amy McKee, VP of Regulatory Consulting for Parexel and former Deputy Director of the FDA Oncology Center of Excellence, shares valuable insights about knowing when and how to engage with regulators.
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In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster,...
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Parexel’s Decentralized Clinical Trials represent an opportunity to rethink and refresh how research studies are conducted.
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The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...
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