Prior to the pandemic, a survey was conducted asking clinical professionals from pharma, clinical research organisations, clinical sites, and clinical vendors alike what they perceived …

The Program for Enhanced Review Transparency and Communication for 351(k) biologics license applications (BLAs) of the US Food and Drug Administration (FDA), provided for in …

The pandemic has taken its toll, transforming many markets and sectors irrevocably. Organisations operating within the clinical trial space alongside cold chain collaborators have had …

In an era of rapid transformation in clinical trials, research sponsors are presented with new logistical and clinical supply management challenges that can be addressed …

Far more than a series of linear quality checkpoints along the way, RBQM spans the clinical trial continuum, scanning data as it accrues and assessing …

The objective of IDMP, to save patient lives, bears repeating, especially given the years that have elapsed since its conception: IDMP will make it easier …

Even though patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating patient information is apathy, …

Risk refers to the chance of suffering loss or injury, or anyone proposing a hazard. The process of risk management identifies, evaluates and prioritises potential …

In the past, the research nurse had little time to read the entire protocol and, to manage scheduled visits, they developed nursing summaries of clinical …

In December 2020, a paper was published in the journal BMJ Paediatrics Open, a respected journal with a relatively modest impact factor of 2.496, regarding …