The importance of ensuring an accurate diagnosis of progressive supranuclear palsy (PSP) is critical for the development of effective disease-modifying therapies that...

IRT systems are commonly credited with helping to ensure that the right drug gets to the right patient at the right time. This digital side of the supply chain suppor...

Peter Muller, Managing Director, Schlafender Hase, Americas, says “Bringing a new drug to market costs millions, so it’s highly risky to leave product labelling and p...

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 bec...

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 countries of Bangladesh, Bh...

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 execu...

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

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 body. However...

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 and requirements ...

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 MD, MS...