Parexel Insights

What's the Future of FSP?

01.06.22 - 6 min - Choosing a partner to successfully navigate the next five years

Master Protocol Trials: What Are the Elements of Success?

12.01.21 - 3 min - The shortcomings of traditional study designs have come into sharp relief during the COVID-19 pandemic. Regulatory agencies and the research community alike have responded, acknowledging the need for different ways of performing clinical trials.

CNS Summit Recap: The Future is Collaborative

11.22.21 - 9 min - Innovation is the lifeblood of research and development in any industry. Scores of industry efforts spanning digital therapeutics, data sciences and decentralized clinical trials represent the greatest opportunity to positively impact patient experiences and outcomes in the history of clinical research. 

Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

11.19.21 - 5 min - The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some important things to keep in mind about the scope of the draft guidance. Importantly, this draft guidance applies only to early-phase clinical trials of CGT products, and the FDA explicitly states...

Biosimilar Development: Are therapeutic clinical trials needed?

11.16.21 - 6 min - In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.

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