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...

The Functional Service Provider model has grown from a tactical staffing mechanism into a strategic outsourcing framework that underpins modern clinical development....

One of the newer areas in which the US Food and Drug Administration (FDA) is exploring its regulatory role is the use of artificial intelligence (AI) in digital ment...

Redefining Participant Support Through Global Contact Centres As clinical trials continue to expand across geographies and adopt decentralised and hybrid models, ens...

For all the innovation reshaping clinical research, one part of the process has remained stubbornly analog: the documents. Protocols, Statistical Analysis Plans (SAP...

Continuous monitoring of safety and efficacy data in clinical trials is a fundamental component of modern clinical research. Because monitoring is complex and involv...