When novel drugs and biologics hit the market, the treatment horizon for many patients is suddenly broadened. US Food and Drug Administration (FDA) ‘firsts’ can …

The current COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, is the current focus of numerous drug therapies and vaccine candidates. We have seen swift …

At the peak of the COVID-19 pandemic, clinical study monitors and patients were restricted from sites. Sponsors and CROs had to reassesshow to keep trials …

Within this evolving world of biopharma, it is estimated that two-thirds of biopharmaceutical manufacturing is outsourced. Therefore, the supplychain is not only complex, but also …

The pressures on pharmaceutical organisations to capture, sift and process real-world adverse event data are immense – and soaring. So why are Safety & Pharmacovigilance …

Contact-tracing apps and technologies are a hotly debated issue with legal, medical and technological implications. The most common mistake in the public debate is to …

The outbreak of COVID-19 created unprecedented circumstances for the conduct of clinical trials across the world. While the industry has experienced challenging conditions in managing …

Clinical research is a complex, expensive, and time- and resourceintensive process. Feasibility assessments play a crucial part in this clinical research planning process as it …

The medical device industry makes a colossal number of items ranging from invasive gloves to non-natural joints to imaging gear andassumes a pivotal job in …

The low representation of African countries in clinical trials is not unusual. Poor visibility of existing sites, limited infrastructure, cultural barriers, misunderstandings of requirements to …