Rare diseases collectively affect an estimated 300 - 400 million people worldwide, despite each individual condition impacting only a small patient population. While...

A year ago, the US Food and Drug Administration (FDA) launched a new “ultra-fast” review programme intended to dramatically shorten review times for drug and biologi...

In the past year, China has rapidly emerged as a key strategic consideration for sponsors planning to run global studies. That marks a sharp shift from the tradition...

Clinical trial clients often face the complex task of a contract research organisation (CRO) transition, moving critical trial functions from one CRO to a functional...

The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging development milestones, beset by u...

Master Protocols have the capacity for great advantages and efficiencies in drug development over traditional trial protocols but can be challenging for sponsors due...