Clinical Trials

Clinical Trials are studies conducted on human volunteers. The process of discovering a molecule or pathway and testing it through animal and multiple human phases until product launch is stretched over 13 – 17 years. 

Good Clinical Practice

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.

The Food and Drug Administration

The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. 

International Clinical Trials Registry Platform (ICTRP)

To ensure transparency and data integrity, all trials are mandated to register Clinical Trials before enrolment of first volunteer. World Health Organization has developed a joint platform of registries to ease the process for researchers.