An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data

The Clinical Trial and Imaging Subgroup of the European Medicines Agency (EMA) has released a report on the issues associated with the combination of data from different clinical trials into large datasets. Read more “An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data”

The EMA has published important guidance on the clinical development of new gout treatments

The finalised guidelines show the European Medicines Agency’s (EMA) expectations of manufacturers involved in the clinical development of new urate-lowering therapies (ULTs) and anti-inflammatory treatments of gout. Read more “The EMA has published important guidance on the clinical development of new gout treatments”

The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals

An article published in Clinical Pharmacology & Therapeutics by the European Medicines Agency (EMA), describes the interactions needed between stakeholders to accelerate patient access to ground-breaking new therapies. Read more “The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals”