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, …
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