by chuck_ltd | 22 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News
Regulation 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (the “Regulation”) Introduction Traditionally, the results of clinical trials have not always been published. This is often due to an increased number of...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence
Non-interventional studies (NIS) are a key tool for collecting information about how a drug is actually used (+ safety, effectiveness, healthcare benefit and value etc…) once it’s been approved (e.g., by FDA in the USA) and accepted for reimbursement...
