AI-enabled clinical monitoring
Rigora runs your monitoring between visits. Your CRA signs.
Rigora runs SDV and SDR continuously, flagging discrepancies and drafting the queries and visit report as data lands.
So your CRAs spend their days on investigator relationships and safety judgment, not on transcription and reconciliation.
How it works
From source document to signed report
Rigora works from the documents your sites already produce — source data verification and source data review, the day the data lands. Sites keep working the way they do today.
Step 01
Source lands
The documents your team already collects, like certified copies of lab reports and visit source, land in Rigora as they're produced. Central-lab feeds and EHR connections can come later; none are needed to start.
Step 02
Rigora reconciles, continuously
Deterministic software verifies each value against the eCRF and reviews it for protocol deviations. Every value carries its provenance; every discrepancy is computed, not guessed.
Step 03
Your CRA triages and signs
Flagged discrepancies arrive with drafted queries and a drafted visit report. The CRA reviews, edits, and signs, then walks into the next visit knowing where to look.
Shows its work
You can check every number we show you
This is the actual artifact: the same components our product renders, with synthetic data.
Most AI demos are magic tricks: output with no visible inputs. Rigora is built the other way around.
A certified copy is not the same claim as an EMR view, so every source value carries its provenance class. An attestation, once made, is frozen; corrections create new versions.
Reviewers see the structured data sent to the model beside every draft. Where the model lacks confirmation, it says so.
Every state-changing action lands in an append-only audit trail, attributed to the person who took it.
Read an annotated visit report →Source data verification
Source provenance
Certified copyFHIR feedEMR view
Sits above your stack
Rigora is read-only, by design
No EDC integration project, no site IT burden, no new system of record to validate.
Reads, never writes
Rigora reads source documents and your EDC. It writes to neither; read-only is enforced at the credential level.
Your CRA raises the query
Queries are drafted here and raised by your CRA in your EDC: Medidata Rave, Veeva Vault, Castor, OpenClinica. Your workflow, faster.
Your systems stay the record
The record you sign stays in your validated eTMF/QMS. We export the evidence of the human review — the signed report and its audit trail; we don't replace your systems.
The platform
Start with nothing connected
Tier 1 · Start here
Continuous monitoring, zero integration.
Works from what your CRAs already have. Between visits, Rigora reconciles source against the eCRF, reviews it for protocol deviations, and triages what deserves on-site time, all with full provenance. It drafts the queries and the visit report (MVR) your CRA signs. No site IT project and no EDC integration.
Tier 2 · Expand — as your studies warrant it
Connected source, one feed at a time.
Central-lab and ECG feeds reconciled automatically: “the eCRF says ‘ECG performed’ — but no result in the central feed. Flagged.” EHR data via FHIR where a site supports it, sponsor-mediated exports where it doesn't. Each connection deepens coverage; none is required to start.
The economics
Monitoring is the biggest line you can still move.
Drug-trial benchmarks; device-study monitoring carries the same templated labor. Every figure is sourced, with methodology and citations here.
The evidence
10,101 eCRFs re-verified. Zero conclusions changed.
“Zero errors that changed any result or conclusion.”
A 2025 retrospective study in Communications Medicine (Nature portfolio) performed source data verification across 10,101 eCRFs from the I-SPY COVID platform trial (NCT04488081) and found zero errors that changed any conclusion. The trial used centralized monitoring by design.
Abbasi et al., Communications Medicine 5, 444 (2025) · DOI: 10.1038/s43856-025-01126-9
If 100% source data verification across 10,000+ fields finds zero consequential errors, the expensive part was never the verification. It was doing it with human hours on site. Rigora makes continuous verification close to free, so your monitors' capped on-site time goes to the data that carries risk. This is the direction ICH E6(R3) and ISO 14155 already point.
Get in touch
See it on your monitoring workload.
CRO, sponsor, quality, or still evaluating — tell us what you're looking at. We'll show you the product on synthetic data. If a pilot is the right next step, we'll scope it on one study.