COO, AG Mednet
The pilot nobody is talking about correctly
The FDA recently announced something that, if it scales, fundamentally rewires what “trial-ready data” means in clinical operations. And almost nobody is talking about it the way they should be.
The agency launched a pilot program where reviewers can access selected clinical trial data in real time, instead of waiting for traditional submission packages. AstraZeneca and Amgen oncology programs are the first participants. AI is being used on the agency side to surface anomalies and trends as data accrues.
Take a moment with that.
When “working state” and “submission state” become the same thing
For decades, the cadence of clinical operations has been built around compiling, reconciling, and submitting periodic data packages. The internal workflow at every sponsor and every CRO is shaped by that cadence. Source-data verification cycles, query resolution, lock procedures, eTMF assembly — they all assume there’s a moment in the future when the data goes from “working state” to “submission state.”
Real-time review collapses that distinction. If a regulator can see your data in flight, then “working state” and “submission state” have to be the same thing, every day, every week, every month of the trial.
Why your current stack can’t handle this
That is an enormous operational ask, and it cannot be met with a stitched-together vendor stack of EDC, eTMF, CTMS, safety systems, and central labs that each have their own definition of when something is “clean.” Real-time review demands real-time agreement, across every system and every party in the trial, about the state of every data point. It demands continuous validation. It demands continuous provenance. It demands continuous governance.
The real story is operational, not technical
This is the part most people miss. The FDA pilot is being read as a technology story — “AI helps regulators review faster.” But the real story is on the sponsor side, and it’s an operational story, not a technical one. To be a credible participant in real-time review, a sponsor’s clinical operations layer has to be architected for continuous regulator visibility. Most aren’t. Most can’t be retrofitted to be.
This is what we built Judi for
This is exactly the problem Judi was designed to solve. Not for the next submission. For the day when the submission isn’t the event anymore — when the data is the event, every minute, in a form a regulator can audit on demand.
If real-time review goes from pilot to standard practice over the next three to five years, the sponsors that thrive will be the ones who treated their clinical operations layer not as a paperwork engine but as a governed, query-able, regulator-ready data and workflow system. That’s a different kind of company. That’s a different kind of stack.
Pilots don’t go nowhere at the FDA
The pilot is small today. AstraZeneca and Amgen, oncology, two companies. But the FDA does not run pilots that go nowhere. The agency runs pilots that become the next operating model.
Plan accordingly.
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John Paul (JP) Lee, COO, AG Mednet. McKinsey alum and Kellogg MBA, JP drives operational strategy for Judi across regulated clinical trial environments.
