The primary goal of drug safety, or pharmacovigilance, is the detection, assessment, understanding and prevention of adverse effects or any other drug-related proble...

Risk-based quality management (RBQM) is now widely recognised as crucial to improving data quality and clinical trial efficiency. Regulatory backing and increasing c...

Reliable medication intake is a fundamental prerequisite for both therapeutic success and the validity of clinical trial outcomes. Deviations from prescribed regimen...

More than 300 million people worldwide live with a rare disease, representing up to 5.9% of the global population. With over 6,000 distinct conditions, 72% of which ...

Everything in a clinical trial should be designed to optimise the success of meeting the trial’s endpoints. This goal starts with developing a flawless protocol, whi...

Rare diseases collectively affect an estimated 300 - 400 million people worldwide, despite each individual condition impacting only a small patient population. While...