Five strategies for meeting the requirements of Project Optimus and improving the chances of approval

EU Orphan Drug Designation – overcoming regulatory challenges

8 things you need to know about eCTDs in China

Although eCTDs are a huge step forward for standardization in the Asia Pacific, there are several important things you need to know before you submit your dossier electronically.

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.

Communicating Value to Providers and Payers

Early planning can help you make the most of expedited regulatory pathways

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.

Three strategies for articulating a coherent product value story

Articulating a coherent product value story from the start of development can help companies attract investors.