What is GCP COMPASS ?

GCP COMPASS is an organisation to contribute in modernising clinical research by ensuring global requirements (Good Clinical Practice) and more importantly respecting regional/ local considerations to deliver proactive quality. This approach requires clinical research domain expertise and pragmatic use of modern techniques (such as Advanced Analytics, Artificial Intelligence, Machine / Deep Learning, Lean & 6-sigma principles).

GCP COMPASS aims to bring the domain expertise from the best of both worlds (i.e. GCP & technology) so as to pass on the knowledge & learning in an effort to give back to the next generation and promote high quality clinical research.

Good Clinical Practice (referred as “GCP”) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH-GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The GCP guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). The expectation is to follow these guidelines when generating clinical trial data that are intended to be submitted to regulatory authorities. Broader ICH guidelines are applied by a growing number of regulatory authorities and now includes 16 Members and 32 Observers.