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

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

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

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

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 it holisticall...

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 to mine pr...

Even though patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating pat...

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 h...

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 trials. Dis...

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 paediatri...