SmartIntel
The clinical trial intelligence platform built for inspection day.
SmartIntel automates the hardest parts of clinical trial operations — protocol amendment comparison, audit trail generation, consent obligation tracking, and regulatory gap analysis — so your team focuses on the science, not the paperwork.
Clinical operations run on hope and Excel.
Protocol amendments cascade silently across sites
One protocol change. Ten downstream documents. Zero automated tracing.
Consent obligations tracked in Excel until it fails
Wrong consent version signed. Reconsent missed. Regulator finds it before you do.
Audit trail assembled manually the week before inspection
Screenshots, email chains, PDF exports. Inspection anxiety guaranteed.
Amendment Intelligence Engine
OCR + LLM comparison of every protocol version. Section-by-section deltas, downstream impact analysis on informed consent, IRB submissions, and site training.
Immutable Audit Timeline
Every action — signed, hashed, chained. Inspection-ready timeline exportable to regulator formats in one click.
AI Gap Detection & Risk Scoring
Continuous scan of trial documentation against GCP, ICH, and site-specific SOPs. Gaps surfaced with severity and remediation path.
Consent Obligation Tracking
Every consent version mapped to every enrolled subject. Amendment triggers reconsent workflow automatically.
Ships aware of the regulations you operate under.
Electronic Records / Signatures
Native audit trail, e-signature bindings.
Good Clinical Practice
Quality tolerance limits, risk-based monitoring.
Global GCP Alignment
EU, US, Japan, India — one platform.
Quality System Regulation
For combination products and devices.
EU Data Protection
Consent, DPIA, right-to-erasure workflows.
Protected Health Information
BAAs, encryption, PHI segregation.
Your data never leaves your boundary.
Azure Private Cloud
Deployed inside your Azure tenant. Full ownership of data and encryption keys.
On-Premises
For sponsors requiring physical data locality or air-gapped environments.
Hybrid
Central sponsor deployment with site-level data localisation.
If you run trials, SmartIntel is for you.
CROs
Deliver inspection-ready trials across every sponsor engagement.
Pharmaceutical Sponsors
Maintain audit-grade oversight across your CRO network.
IRBs & Ethics Committees
Real-time protocol and consent traceability.
See the platform end to end.
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