The (FDA) asked an advisory committee to meet twice in two weeks to discuss nearly identical products with similar indications from two different pharmaceutical compa...

There are many challenges that clinical research may face, and there is a risk of failure along the many phases of development. For a trial designer, there are many i...

For patients with rare diseases, social media conversations are a gateway to uncovering information regarding condition coping and treatment. Likewise, for those who ...

Since its formalisation in 2006, the Cardiac Safety Research Consortium (CSRC) has facilitated research projects, think tanks, and many publications in medical and sc...

The emergence of Big Data and other advances in data science approaches and tools are providing medical researchers with the opportunity for previously unobtainable i...

In 2012, the European Union (EU) introduced regulatory controls for good pharmacovigilance practices (GVPs) to its member states. Since then, pharma businesses operat...

The Netherlands has been a natural favourite for conducting clinical research with the Dutch healthcare system ranking among the best in Europe, the high level of edu...

The formulation of a candidate drug for first in human (FIH) trials is of great importance – how a pharmaceutical company chooses to approach this challenge can ultim...

IPF is a rare disease, in which patients are most often affected from middle age, and its manifestation is characterised by severe, irreversible interstitial fibrosis...

Amyotrophic lateral sclerosis is a neurodegenerative disorder affecting predominantly central and peripheral motor neurons, resulting in progressive weakness and atro...