Six workflows, one standard of oversight
Available today — some delivered directly, some through vetted partners under AyurDatta's governance.
AI-assisted protocol authoring
Structured digital protocols to ICH M11 / USDM — consistency checks and reuse downstream, not a one-off document.
Human sign-off: Physician and statistician review
AI-assisted data cleaning & medical data review
Anomaly detection, query drafting, and reconciliation — surfaced for a data manager and medical monitor to act on, not auto-resolved.
Human sign-off: Data manager and medical monitor
Clinical & safety document generation
SAE narratives, DSUR/PSUR sections, CSR sections, and briefing documents — drafted fast, signed by a named physician or medical writer.
Human sign-off: Named physician or medical writer
Biostatistics & programming automation
SAP support, SDTM/ADaM programming, and tables/listings/figures — generated fast, QC'd by a biostatistician before anything ships.
Human sign-off: Biostatistician QC
Safety signal analytics
Disproportionality and trend analysis on the Medical Oversight Workbench — every signal adjudicated by a named physician.
Human sign-off: Physician adjudication
Feasibility & enrollment analytics
Site-selection support and predictive enrollment modeling — reviewed by your clinical operations lead before a site commitment is made.
Human sign-off: Clinical operations lead
One workflow, one measured outcome, then scale
One bounded workflow
A single use case, a single team, a defined success measure — before anything scales.
Validation evidence, as you go
The pilot generates its own validation evidence — mapped to your quality framework, not assembled retroactively.
Extend once proven
Only once the measured outcome and the sign-off record both hold up does the workflow extend to the next team or modality.
The same architectural invariant, every time.
No AI output becomes a record of decision without a qualified human's review and signature — the bypass is engineered out, not policed after the fact. It's the same invariant that runs the Medical Oversight Workbench, applied to every solution on this page.
See the Workbench architecture →Scope a governed pilot.
Bring us the workflow that's eating your team's time — we'll tell you whether AI can carry it, and who signs off when it does.
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