by chuck_ltd | 3 Apr, 2017 | 21 Century Cures Act, Cures Act, EU Clinical Trials Regulation, Pragmatic Trials
It’s been 50 years since Schwartz and Lellouch(1) first introduced the concept of pragmatic clinical trials (PCTs) and now major changes in the EU(2) and USA(3) regulations have made the conduct of these PCTs more favourable, but who, if anyone, is conducting...
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...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, GCP, News
Implementation of the EU Clinical Trial Portal to be Postponed Until the End of 2017 Highlights from the meeting include: Document “Outcome of the public consultation on the EU Medicines Network Strategy to 2020” adopted, next steps endorsed. Implementation of the...
