Veristat Presents Instat

Post-Database Lock Used to Be the Bottleneck.

Now It's the Part That Moves Fastest.

Your Biostat team shouldn't be the last thing standing between you and submission.

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Days Instead of Weeks for Submission-Ready TLFs

The clinical research industry’s first zero-code, fully automated biostatistics solution.

InStat™ compresses the path from database lock to submission-ready TLFs from weeks to days with validated statistical engines, full lineage on every output, and expert biostatistician oversight throughout.

The Bottleneck

The Bottleneck Every Study Hits

At database lock, the clock starts. Tables, listings, and figures sit directly on the critical path for submissions and study reports, yet most organizations still rely on slow, manual workflows to produce them.

Four to six weeks for final TLFs remains standard. Review cycles can add another month.

InStat replaces study-by-study programming with specification-driven execution, removing rework, reducing delays, and shortening one of the most compressed phases in clinical development.

Ask Again. And Again.

In the old model, every additional run had a cost: a programmer pulled off another project, a revised timeline, a conversation about whether it was worth it. With InStat, if you want to see the data cut a different way, you ask. Running it again is no longer the expensive part.

You're Never Waiting in the Dark.

You don't get an output drop three weeks after database lock and hope it matches what you specified. You can see the work as it happens, executing against the specifications you reviewed and approved. The process is open, not opaque.

When You Need Something, You Get It Back Fast.

That last-minute scramble — the midnight run to meet a regulatory deadline — compresses dramatically. Turnarounds that took weeks take days. Days take hours. The timeline has more give than it ever has.

Not Fewer Errors. Whole Categories, Gone.

When analysis isn't hand-coded and hand-checked by a programmer working under deadline pressure, the mistakes that come from hand-coding simply can't happen. We didn't reduce the error rate. We removed the source.

Table

The Loop That Consumed Your Timeline — Replaced.

Traditional TLF production is a loop: program, QC, reconcile, repeat. Every protocol deviation, every analysis plan amendment, every late request restarts that loop.

InStat replaces the loop with a specification-driven engine. Changes reflect the same day. The process doesn't restart — it responds.

Instead of manual SAS programming and repetitive QC cycles, InStat uses pre-validated statistical engines and automated execution to generate outputs consistently and reproducibly.

Running on Real Studies. Real Data. Real Submissions.

Here's what that looks like in practice.

Clene Nanomedicine
Clene Nanomedicine's NfL biomarker analyses supporting their CNM-Au8 ALS program and planned NDA submission were produced with InStat. Not as a proof of concept. As the actual work.

"Veristat produced the supporting NfL biomarker analyses with InStat, delivering tables in days rather than the weeks that similar analyses typically demand."

Michael Hotchkin

Chief Development Officer, Clene Nanomedicine

Built tested running

Built. Tested. Running.

Validated against real clinical study data
Deployed on NDA-track ALS program
NDA-supporting analyses completed and delivered
Full lineage and traceability on every output, from first run
Rolling into active Veristat biostatistics delivery in June 2026

Ready to See the Difference?

Book a conversation with our biostatistics team. We'll show you exactly how InStat works and what it would mean for your next study.

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