As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals? Carla Griffin, CEO of The Sugar Water Operations Team, argues that reg ops has been kept in too small a box for years and that this shift is the opening to change that.
Carla and Nick Capman get into why the hardest adjustment is professional rather than technical, how to vet technology vendors who don't understand your regulations, and the three things reg ops professionals should do in the next twelve months.
A few of Carla's key takeaways:
Reg ops specialists are problem solvers who've been siloed into links, bookmarks, and document construction
The instinct that makes reg ops strong, wanting everything systematic, is what will make this shift hardest
Getting reg ops and IT into decisions earlier isn't optional if the goal is getting data to FDA faster
When evaluating technology, look for options rather than solutions, then eliminate risk to make an option viable
Ask vendors whether they understand the regulations you're held to. If they can't answer, move on
Put on your FDA hat: where do the data integrity questions come from, and can you show a human was in the loop?
Old technology isn't the enemy. It's just at a disadvantage now
Note that this was recorded in September 2026. The FDA's real-time clinical trials work has been developing quickly, and Carla's forward-looking comments are her own assessment rather than announced agency policy. New developments may supersede the information provided here.
About Carla Griffin
Carla Griffin, M.A., M.S., is CEO and Principal Operations Consultant at The Sugar Water Operations Team (SWOT), supporting emerging biotech and pharmaceutical companies across regulatory operations, submissions management, and quality systems. She has close to two decades of experience, including eight years at Esperion leading development and regulatory operations, with earlier roles at Sarah Cannon Research Institute, LIQUENT (a PAREXEL company), and Human Genome Sciences. She holds a master's in regulatory science from Johns Hopkins.
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
