Benchmarking Survey: Is EU CTR driving tighter Clinical & Regulatory Integration?
The newClinical Trials Regulation(EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. As just one example, starting 31 January 2023 sponsors must use the new Clinical Trial Information System (CTIS) portal to apply to start a new clinical trial in the EU/EEA.
Did you know that between 14th and 20th March 2022 there were 7,757 logins to CTIS , more than 250 draft applications and 16 submitted applications in CTIS? How is your organization preparing for CTR and CTIS? What obstacles are you encountering?
Phlexglobal have launched an industry survey designed to benchmark progress and obstacles to this significant new regulation. Complete the form on this page to access the survey: