After nearly two years of postponed or remote site inspections due to the pandemic, the FDA appears to have returned to normal on its good clinical practice (GCP) inspections and routine surveillance. Read More
As more sponsors and sites use the flexibility offered by eConsent and remote consent, they’re also dealing with some concerns attached to those approaches, especially the documentation that the FDA will ask for during inspections. Read More
Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the IRB at Hennepin County Medical Center (HCMC) over IND and informed consent issues on some of their trials. Read More
When the FDA gets tough on clinical trial transparency, the industry listens. The problem is the FDA doesn’t get tough with enough regularity. Read More
Site networks IACT Health and LMC Manna Research have combined their operations in a strategic alliance, joining forces to create one of the largest research networks in North America. Read More
