The principles of Good Clinical Practice (GCP) serve to ensure the protection of trial participants and the integrity of the data recorded. Katrien Lemmens at …

Harmonisation of data standards has been a popular topic recently at the US Food and Drug Administration (FDA) and other regulatory organisations. Governmental regulation attracts …

As clinical trials become more complex, so does the task of ensuring the right supplies are in the right place at the right time. Protocol …

Early access programmes are becoming more common and more sophisticated, requiring greater attention and resources from sponsors. The FDA’s pilot programme is designed to help …

Clinical research is changing rapidly alongside the growing prevalence of “smart” technology. Data is being generated beyond traditional clinical settings – originating in disparate locations …

Within the next three years, the pharma and biotech industries will be at a point of deploying AI and machine learning to transform the pace …

Five years after Clinical Trial Regulation (EU) first came into force, development of the clinical trials portal and database that will trigger its official application …

Personal data concerning health should include all data pertaining to the health status of a data subject which reveal information relating to the past, current …

As momentum builds anew towards ISO IDMP compliance, life sciences companies could be forgiven for a lacklustre response, after a series of delays. Most organisations …

North Africa is the region covering the northern part of the African continent and can be defined as the area covering Morocco, Algeria, Tunisia, Libya, …