June 07, 2022
Tech companies entering space must adapt and adhere to regulations set by FDA.
March 10, 2022
Brief history lesson sets stage for current state of CROs.
January 03, 2022
New requirements must be put in place to ensure data quality and integrity.
December 07, 2021
Lessons learned from FDA’s current process and proposed alternative review strategies.
April 01, 2017
How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.