In this article, Deborah A. Komlos at Clarivate Analytics describes the high importance of the communications between sponsors and the US Food and Drug Administration …

Navigating the ever-growing regulatory and compliance complexity in life sciences is a challenge that most in the industry struggle with at times. Yet there are …

In recent years, health insurers have argued that the high price tags on drugs for rare diseases are unsustainable. For America’s Health Insurance Plans (AHIP), …

Successful delivery of clinical trials depends on many factors, not the least of which is having an effective clinical trial supply chain for investigational products. …

Enrolling insufficient numbers of subjects to power a clinical study is often cited as a major reason for failure to achieve statistically significant endpoint or …

With the growing number of clinical trials and increased complexity across the clinical lifecycle, life sciences organisations are under more pressure than ever to improve …

From heightened demands by regulatory authorities for contextual demonstration of the benefits and risks of a drug, to the need for pharmacovigilance to play a …

The introduction of ICH E6 (R2) this past year has rendered the implementation of risk-based monitoring principles a matter of GCP compliance. While clinical research …

Sandrine Bresard and Frederic Nouaille at i4CT analyse how important insurance is in clinical trials and how local requirements are very different, depending on the …

Through this article, Jaime Polychrones at Clarivate Analytics draws attention to the memorable 2017, when the US Food and Drug Administration (FDA), for the first …