Automate management and creation of trial master files to accelerate study start-up for clinical ops and clinical IT.
ACRP Interim Executive Director Terri Hinkley recently took a few minutes to chat with us about the groundbreaking initiative of the Joint Task Force for Clinical Trial Competency.
Ken Skodacek, policy analyst for the clinical trial program in the Office of Device Evaluation, CDRH, says the FDA “wants to stay out of the way of rapidly evolving technologies that ultimately promote public health.”
FDA has a message for sponsors that want to incorporate mHealth technology into their clinical trials: as long as the technology can be clinically meaningful, don’t let us get in your way.
I will be on a great panel on risk-based monitoring and eSource methodologies at DIA June 16, and I want to highlight a few points from my presentation.