EU Orphan Drug Designation – overcoming regulatory challenges

How to better prepare patients for a cell or gene therapy trial

Parexel spoke with Doug Olson, Cancer survivor and CAR T-cell patient, about how healthcare providers and trial sponsors can better communicate with patients about CGTs.

How biotechs can strengthen their value story with advanced analytics

Read five ways biotech companies can enhance their value story with advanced analytics.

Want to run a patient-centric rare disease trial? Be site-centric

Patient and site-centricity go hand-in-hand.

New endpoints for early-stage cancer are gaining regulatory traction

Five lessons for building an external control arm that regulators can use

How emerging biotechs can enter the Chinese market and prosper

In this article, Parexel experts outline five approaches that foreign companies with limited resources should use to gain a foothold in the Chinese market.

Making Expedited Regulatory Pathways Work for Global Drug Development Programs

Article from December 2021 edition of Applied Clinical Trials. Parexel regulatory experts offer top tips for working with regulators on a global scale.

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.

Maximize the efficiency of regulatory operations with five key competencies

In this article, Parexel regulatory outsourcing experts explore five competencies companies can use to manage post-marketing regulatory requirements better and more efficiently.

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

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

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.

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

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.

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.

Navigating COVID-19 to Support Next-Gen Patient-Focused Treatments

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.

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.

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.

Entering a new age of evidence generation: synthetic control models

Expert perspectives from Parexel's Leanne Larson, Senior Vice President and WW Head of Real-World Evidence