Everything in a clinical trial should be designed to optimise the success of meeting the trial’s endpoints. This goal starts with developing a flawless protocol, whi...

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...