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Three ways to work with the FDA for better patient-focused trials

Useful practices for getting the most out of your collaboration the FDA

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Decentralized trial tools and technologies are here to stay: A regulatory perspective

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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Maximize the efficiency of regulatory operations with five key competencies

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Lessons from China and the United States on the use of RWE in regulatory submissions

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Four reasons to conduct robust natural history studies before clinical trials

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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Can Synthetic / External Control Arms meet regulatory and HTA requirements?

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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4 insights on decentralized trials for biotechs _ BioPharma Dive.PXRL

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How to accelerate oncology clinical trials through site relationships and patient insights

Learn how all stakeholders benefit when patients and their insights are at the heart of every aspect of clinical development.

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Four Keys to a Smoother Clinical Development Journey

Whitepaper recently published in Fierce Biotech providing perspectives on how the right partner can help bring all the disciplines together for a successful development program.

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Multi-stakeholder strategies for external control arms

New ways of thinking are needed about vast sources of data amassed — and how that data can be fit-for-purpose to meet drug approval and access standards.

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How a joined-up development strategy pays off for early-stage biotechs

Parexel Biotech’s Nate Akers, VP, Business Development, and Vicky Hsu, Head of Operations in Asia discuss the importance of aligning clinical execution with a clearly defined regulatory strategy.

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Our latest Cell & Gene Therapy content, all in one place
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Decentralized Trials: Considerations for Building a New Patient-Centric Model

Graciela Racaro, Global Head of Operations for Parexel Biotech, discusses the advances we have seen in the past year towards a more patient-centric environment.

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Jim Anthony: A personal connection to driving great medicine in the future

Jim Anthony, Global Head of Parexel Biotech, describes how losing his father to an incurable disease and his early experiences in science and business led him to his role helping biotech companies.

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Graciela Racaro: A personal connection to driving great medicine in the future

Graciela Rácaro, Global Head of Operations for Parexel Biotech, discusses how she has had to change the course of her career direction multiple times on the way to meeting her ultimate goal.

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Ubavka DeNoble: Helping our customers in moments that matter

Ubavka DeNoble, Senior Medical Officer for Parexel Biotech, shares how her experiences taught her the power of adapting and persevering against long odds that’s shared by everyone at Parexel Biotech.

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Skip Sands: Helping our customers in moments that matter

Skip Sands, Senior Medical Officer for Parexel Biotech, explains how his family history, his career in medicine, and his experience with inadequate medical care inspire him.

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Parexel Biotech Brochure

Learn about the services and approaches that Parexel Biotech offers to help you make an exponential difference in patients’ lives.

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Tips for building your oncology reimbursement strategy

In this infographic, we share five tips for building an effective reimbursement strategy for your oncology product.

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Decentralized clinical trials - A more patient-centric approach

Decentralized clinical trials, where portions of a study are conducted outside a traditional trial site, offer new opportunities — and new hope — for patients struggling with inflammatory conditions.

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Guide for Real-World Evidence

Parexel Biotech has created this guide to simplify the nomenclature and types of real-world studies.

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