You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Sponsor-Investigators are uniquely dedicated and invested in clinical research. In a previous blog post, IMARC described how Sponsor-Investigators have to wear two hats and follow two sets of regulations.
Topics: Sponsor-Investigators, 21 CFR 50, FDA, IRB
After reviewing warning letters issued to investigators and sponsor-investigators last year, through FDA’s Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the 2011 “TOP 10” list. This list is not intended to point fingers at investigators, but rather, to document the non-compliance trends in an effort to raise industry awareness of improvement needed. Whether you are a sponsor, a monitor, or an investigative site, everyone has a stake in the outcome of an FDA BIMO inspection.
Topics: Sponsor-Investigators, FDA BIMO inspection, FDA Warning Letters