Sponsors are Being Asked to do a Risk-Assessment and Record this Internally
FDA, EMA, MHRA, etc., have started to distribute guidance on how sponsors should manage clinical trials during the Coronavirus crisis. All studies are affected. Ad-hoc risk assessment is required.
Cyntegrity has launched a risk catalog “COVID-19 RACT”, which contains ALL regulatory pieces of advice known until now, providing study teams with mitigation actions against the COVID-19 risk impact on ongoing studies. To keep the COVID-19 RACT current, the catalog is updated on a daily basis.
MyRBQM® RACT Library
The COVID-19 RACT catalog, included by default into MyRBQM® Portal, is an urgent addition to the growing library of therapy specific RACTs.
- Built on the TransCelerate methodology
- Enhanced with complementary risk mitigation actions
- Fully customizable & expandible
- Comes standard with MyRBQM® Portal and COVID-19 rapid deployment pack