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11.19.21 - 5 min - The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some important things to keep in mind about the scope of the draft guidance. Importantly, this draft guidance applies only to early-phase clinical trials of CGT products, and the FDA explicitly states...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

Clinical pharmacology, modeling and simulation to support FIH study design

10.21.21 - 4 min - A major challenge in drug development is the translation of candidate molecules from the preclinical phase to the clinical setting. The key elements to be considered are the pharmacology, toxicology and pharmacokinetic (PK) properties of the candidate molecule, and the quantitative relationships among dose, concentration, target engagement, efficacy, and/or toxicity.

Actigraphy advances a patient-first approach: Reduce patient burden — and make the most of valuable data 

10.15.21 - 7 min - In a patient-centric clinical trial, we focus first on patient needs, finding ways to make participation simpler, more comfortable, and less invasive...

Rethinking FSP outsourcing

10.04.21 - 6 min - Why a programmatic approach yields better results

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EQT Private Equity and Goldman Sachs Asset Management Complete Acquisition of Parexel

Parexel and Kyoto University Hospital Announce Strategic Alliance

Parexel Strengthens Clinical Data and Digital Services Offering with Key Appointment

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