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Regulatory operations professionals tend to get described by their outputs.
Hyperlinks, bookmarks, publishing, the mechanics of getting a dossier out the door correctly. Carla Griffin’s argument is that the description has always been too small and that a shift now underway at the FDA will make that obvious.
Nick Capman sat down with Carla to discuss what happens to reg ops professionals as the FDA reimagines how clinical data reaches the agency, and how they can lead that shift rather than be disrupted by it.
Carla is CEO and Principal Operations Consultant at The Sugar Water Operations Team, known as SWOT, which provides right-sized regulatory operations, submissions management, project management, and quality support to emerging biotech and pharmaceutical companies.
She has close to two decades of experience in regulatory and business operations, including eight years at Esperion, where she led development operations, regulatory operations, submissions management, and medical writing, and later headed strategic business operations. Before that, she held regulatory roles at Sarah Cannon Research Institute, LIQUENT (a PAREXEL company) specializing in eCTD dossiers and submissions, and Human Genome Sciences. She holds a master’s in regulatory science from Johns Hopkins and a master’s in professional, technical, business, and scientific writing from Towson University.
A note on timing and context
This conversation was recorded in September 2026 and discusses FDA’s real-time clinical trials work, which has been moving quickly.
For readers who want the current state: The FDA announced the initiative on April 28, 2026, under the name Real-Time Clinical Trials (RTCT), with two proof-of-concept studies. AstraZeneca is running the Phase 2 TRAVERSE trial in treatment-naïve mantle cell lymphoma, and Amgen is running the Phase 1b STREAM-SCLC trial in limited-stage small cell lung carcinoma.
Both use Paradigm Health’s Study Conduct platform, and the FDA has said that trials in the broader program will run through it. The FDA has already received and validated signals from the AstraZeneca trial. The agency issued a Request for Information, extended the comment period to June 29, published selection criteria in July, and expected to complete pilot selections in August.
The agency has projected trial duration reductions in the range of 20 to 40 percent. Carla’s forward-looking comments below are her own reading of where this leads, and she’s explicit that much remains undetermined. Everything here is subject to change as time goes on.
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Carla's key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
What’s actually changing is the gap between data existing and FDA seeing it. Carla has been in the industry for twenty years, starting when submissions still involved paper. Plenty has advanced since, but one thing has stayed constant: the time it takes to receive data and get it to the agency. Real-time clinical data collapses that window. That’s the change, and everything else follows from it.
The current model waits on Module 5. While data is being produced and cleaned, teams prepare Modules 1 through 4: administrative, summary, CMC, and nonclinical. Then Module 5, the clinical content, arrives wrapped in a clinical study report, and the whole package goes at once unless you’re doing a rolling review. If the agency has been watching signals as they emerge, the questions that follow are open ones. What does that mean for the ESG gateway? Does information get resubmitted after the fact? Do clinical study reports serve the same function? Carla’s answer is that the industry just doesn’t know yet.
The data cleaning question cuts both ways. Between data entry and data management, a lot happens before FDA normally sees anything, and it’s generally viewed as a good thing that the agency doesn’t receive raw data. How data gets cleaned before reaching the agency under a real-time model, and whether the agency scrutinizes it differently knowing the sponsor hasn’t had the usual time, is something Carla says remains to be seen. She wouldn’t call it a positive or a negative yet.
The clear positive is patient access. Shortening the interval between knowing a drug is effective and getting it to patients is the point, and these programs are aimed at serious unmet medical need. Carla is unambiguous that this part is a win.
On timelines, she speculates and says so. Asked how much time might come out of review and approval, Carla offered fifty percent, while noting that many pilot details had not been made public. Her reasoning is that if clinical data arrives continuously, the other modules have likely already been reviewed in some form, leaving clinical review, labeling, and launch. Worth reading alongside FDA’s own projection, which is a 20 to 40 percent reduction in trial duration, a related but different measure.
The hardest adjustment is professional, not technical. Reg Ops is a black-and-white crew, in Carla’s words, and that systematic instinct is a genuine strength. It’s also the thing most likely to get in the way here. ESG and the processes built around it are fifteen to twenty years old in places. Adapting may mean clearing the slate rather than mapping new requirements onto old workflows, and asking “how will this work?” too early can become a reason not to move.
Expect less runway than usual. FDA has historically given industry time to absorb change. Carla’s expectation is that this window will be shorter, and reasonably so, because the whole point is getting products to patients faster.
She raises the possibility that ESG itself changes. Carla floats this and immediately hedges it, so read it as a question rather than a forecast. Her observation is that FDA now has tools it didn’t have when ESG was built, including the NextGen Portal, which has made things like INTERACT meeting requests and BLA number requests considerably simpler than routing everything through the ECTD and ESG structure. Her point is less that ESG disappears and more that industry shouldn’t expect the FDA to remain anchored to a standard just because the industry invested heavily in it.
Reg ops people are problem solvers who’ve been siloed. This is the heart of her argument. Reg ops specialists are often the first to see a solution, and they’ve narrowed it down to links, bookmarks, and document construction. Their capability is broader than the role usually allows. A shift this significant creates the reason to bring them, and IT, into decisions much earlier.
Getting to the table earlier is the whole opportunity. If the goal is getting data to the FDA sooner, you have to examine whether your current infrastructure supports it, and that examination requires reg ops and systems people in the room. Carla’s warning is direct: reg ops has historically not been included as early as it should be, and if that continues, the function does itself a disservice and falls behind.
Speed to market is where the cost of waiting shows up. For biotech in particular, exclusivity and getting there before the market saturates are what keep investors satisfied. Carla’s picture of the company that doesn’t adapt is one that ends up on the sideline, potentially readjusting an indication because someone else arrived first.
AI tools are what reg ops already used, on steroids. Reg ops professionals like technology and are constantly looking to improve what they have, so the enthusiasm is natural. Her caution is the industry’s standing one: just because you can do something doesn’t mean you should. But she pairs it with the reverse: that something looking risky isn’t a reason to run from it.
Look for options, not solutions. This is the sharpest reframe in the conversation. When evaluating technology, reg ops shouldn’t be hunting for a solution. It should generate options, then apply what it knows to eliminate risk and turn an option into something viable. That’s a problem-solving posture rather than a purchasing one.
Everything compresses. Carla expects what would have taken five years to take two, and what would have taken two to take six months, simply because of the pace of technology. Her conclusion is that sitting on the sidelines waiting for others to lead on something like this is a luxury the industry no longer has.
But don’t chase everything, either. Asked how much to get ahead versus wait, she called for balance and meant it. Chasing every solution produces exhaustion, and there’s still day-to-day work to do. Carve out time to listen to podcasts, attend webinars, and talk to peers about what they’re doing. There’s also something to be said for letting others vet solutions and joining when the timing suits you.
Three things to do in the next twelve months.
Stay aware of what’s out there without dismissing it as short-lived. Free podcasts and webinars let you monitor developments without spending real resources, which matters when you’re a team of one or two.
Understand the quality implications, because what makes a strong reg ops specialist isn’t knowing how to use a tool but understanding the consequences of using it.
And learn to vet vendors properly!
Put on your FDA hat! Carla spent significant time on FDA inspections, and she uses that lens deliberately.
Where are the data integrity questions going to come from?
Why did we do what we did, and how?
How do we troubleshoot?
How do we demonstrate that a human was in the loop alongside an AI solution? Her recommendation is to sit with your quality professionals, read your guidances and regulations, and pressure-test what you’re planning before you do it.
Vendor vetting is the most concrete advice in the episode. Plenty of vendors will tell you they can build it, and Carla assumes they can. The question is whether they can build for this industry. Are they aware of the regulations you’re held to, and how do they help you address them? If a vendor can’t answer that, and the task is to get a viable solution running quickly, she doesn’t spend time there. Those vendors fall away, and the ones who understood your challenges from the start are the ones worth pursuing.
Old technology isn’t the enemy. She’s excited about what’s next, but not for its own sake, and she values the things in this industry that have worked for a long time. ESG took enormous effort and remains a strong system. The task now is finding the balance: keeping what’s tried and true, enhancing it with capabilities that didn’t exist before. Old technology isn’t the enemy. It’s just at a disadvantage now.
One thing to bring back to your team
Look at when your reg ops and systems people enter a program.
If the answer is at the point of publishing, or when a submission is being assembled, that’s the pattern Carla is describing here. The cost of it isn’t visible until something changes underneath you, and then you’re mapping a new requirement onto a workflow built for a different world.
Then ask:
If your data pipeline had to support continuous reporting to FDA, who in your organization could tell you today whether it does? Have you asked them?
When you last evaluated a technology vendor, did anyone ask whether they understood the regulations you’re held to, and did the answer change your decision?
And the version Carla would ask: where are the data integrity questions going to come from, and have you sat with your quality team to pressure-test that before building anything?
Carla Griffin, M.A., M.S., is CEO and Principal Operations Consultant at The Sugar Water Operations Team (SWOT), which provides right-sized operational support to emerging biotech and pharmaceutical companies across regulatory operations, publishing and systems, submissions and project management, clinical operations, standard operating procedures, and medical writing. She has close to two decades of regulatory and business operations experience, including eight years at Esperion, where she led development operations, regulatory operations, submissions management, and medical writing before heading strategic business operations. Earlier roles include Senior Manager of Regulatory Affairs at Sarah Cannon Research Institute, Senior Regulatory Affairs Consultant for eCTD dossiers and submissions at LIQUENT (a PAREXEL company), and Manager of Regulatory Operations at Human Genome Sciences. She holds a Master of Science in regulatory science from Johns Hopkins University and a Master of Arts in professional, technical, business, and scientific writing from Towson University.
Connect with Carla on LinkedIn here.
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