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

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 …

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

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

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

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

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 …

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

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 atrophy of voluntary skeletal muscle. It …