As artificial intelligence (AI) becomes increasingly integrated into clinical research, Institutional Review Boards (IRBs) face new challenges in evaluating associat...

The importance of clear, consistent communication between contract research organisations (CRO), sponsors and trial sites cannot be stressed enough. Effective collab...

The major regulators have a minimum expectation that all pharma companies will be taking a proactive approach to real-world safety monitoring. As part of this, they ...

Africa’s position in the global drug development landscape is transforming. Increasingly, sponsors are viewing the region through the lens of opportunity, especially...

Nowadays, when everything seems to be about artificial intelligence (AI), it is easy to forget that there are other technologies that will likely impact on how clini...

Artificial Intelligence (AI) continues to evolve at an unprecedented pace, reshaping the way organisations operate, innovate, and make decisions. Among its most tran...

Recruitment and retention are among the most persistent operational challenges in clinical trials, directly influencing timelines, budgets and data quality. In the U...

Barbara Arch, Principal Statistician at Phastar, discusses the use opportunities and challenges of using electronic patient reported outcomes (ePROs) for primary end...

In the current pharmaceutical environment, where the industry faces a potential patent cliff ranging anywhere from $236–400B in revenue,1,2 sponsors are under mounti...

In September 2025, Spain’s national medicines agency, AEMPS, announced a significant regulatory change: the expansion of its fast-track assessment procedure to inclu...