We now have two methods to fulfill the regulatory requirement to thoroughly evaluate ECG effects of new drugs. Superficially, the CEM approach may seem preferable …

India is the seventh largest country in the world by total area, with the second highest population at 1.2 billion, and is bordered by the …

The use of block enrolment in ophthalmology trials helps enrolment keep up with the speed of these studies. However, the challenges inherent in their successful …

The focus of the comprehensive in vitro proarrhythmia assay (CiPA) is on delayed repolarisation and Torsades de Pointes (TdP) proarrhythmia, a rare but potentially lethal …

The ratification of the E14 guideline in May 2005 by the ICH steering committee presented the first major safety guidance adopted by a global regulatory …

As can be seen in all areas, civil society organisations and initiatives are of key importance in clinical research. In order to translate the ideas …

Being the final feature of this four-part series of medical management of clinical trials, Mohamed El Malt, MD,PhD, Vijayanand Rajendran, MD and Kelechi K. Olu …

Quality in translation is important. Everybody knows that. In this piece, Simon Andriesen, founder and CEO of MediLingua, will show you how to stay away …

Each year, as autumn is well underway, seasonal influenza vaccinations become a topic of conversation for everyone in general and for those with children in …

Engagement has recently been established as a key concept within clinical trials. This trend has delivered a multitude of benefits for participants, who, rather than …