Problem 01
Fragmented eTMF Management
Documents expire, signatures go missing, and audit findings accumulate because manual review cannot keep pace with multi-site trials across geographies and timelines.
B2B Clinical AI Platform
Two Engines.
One Single Source of Truth.
The eTMF Intelligence Engine and Clinical Evidence Engine converge into one AI-driven platform — continuously monitoring, classifying, and surfacing insights across your entire trial tech stack. Fully compliant with 21 CFR Part 11, FDA, ICH/GCP, and HIPAA.
eTMF Intelligence
CDISC Reference Model · Auto-Classification · Continuous Monitoring
Clinical Evidence
Endpoint Analysis · Real-Time Signals · Evidence Synthesis
Single Source of Truth
AI Core — Unified Intelligence Layer
Compliance
CFR · FDA · ICH/GCP · HIPAA
Tech Stack
EDC · IRT · CTMS · Safety DB
The Problem
Clinical Trials Drown in Disconnected Data
Sponsors and CROs manage dozens of systems with no unified intelligence layer. The result: audit findings, delayed submissions, and millions lost to preventable gaps.
Problem 02
No Real-Time Evidence Synthesis
Clinical evidence — endpoints, safety signals, efficacy data — lives in silos. Teams cannot synthesize findings fast enough to inform protocol amendments or submission strategies.
Problem 03
Disconnected Trial Tech Stack
EDC, IRT, CTMS, ePRO, safety databases, and central labs each produce data in isolation. There is no single intelligence layer connecting them into one actionable view.
Problem 04
Compliance Risk at Scale
21 CFR Part 11, ICH/GCP, HIPAA, and GDPR requirements compound with every site added. Manual compliance monitoring is unsustainable beyond a handful of concurrent trials.
The Solution
Two Purpose-Built AI Engines, Unified
Each engine solves a distinct operational challenge. Together they form a single intelligence layer across your entire clinical operation.
eTMF Intelligence Engine
Built on the CDISC eTMF Reference Model, this engine continuously reads, classifies, and monitors every document across every site — eliminating the backlog before it begins.
- AI-driven initial review and auto-classification against CDISC zones, sections, and artifacts
- Continuous monitoring for expired documents, missing signatures, incomplete records, and audit-critical gaps
- Site-specific email templates generated at configurable intervals — one-click forward to site or automated send with internal CC
- Predictive audit readiness scoring by site, country, and study
- Real-time TMF Completeness Index dashboard with drill-down to artifact level
Clinical Evidence Engine
Aggregates and synthesizes clinical evidence from across the trial tech stack — surfacing signals, trends, and actionable insights in real time for medical, regulatory, and operational teams.
- Automated endpoint analysis: primary and secondary outcome measures tracked continuously
- Safety signal detection with severity-weighted alerting and auto-narrative generation
- Evidence synthesis across EDC, central labs, safety DB, and literature — unified in one view
- Protocol deviation pattern recognition with root-cause clustering
- Submission-ready evidence packages auto-assembled per regulatory authority requirements
How the eTMF Intelligence Engine Works
The engine ingests every document uploaded to your eTMF and runs it through a multi-layer AI pipeline mapped to the CDISC eTMF Reference Model's zones, sections, and artifacts taxonomy.
- Ingest & Parse: OCR, NLP extraction, and metadata tagging on upload — no manual indexing required
- Auto-Classify: Documents mapped to correct CDISC zone/section/artifact with confidence scoring; edge cases flagged for human review
- Continuous Monitor: Scheduled sweeps identify expired documents, missing required signatures, version mismatches, and incomplete milestone artifacts
- Site Notification: Configurable interval email templates (weekly, bi-weekly, monthly) generated per site with specific action items — teams forward to site in one click or configure auto-send with internal CC
- Audit Readiness: Predictive scoring model grades each site's inspection readiness, surfacing the highest-risk gaps before an auditor arrives
- Dashboard & Reporting: Real-time TMF Completeness Index, audit finding tracker, and trend analytics — exportable for sponsor oversight committees
How the Clinical Evidence Engine Works
Connects to your trial tech stack via secure, validated API integrations. Data from EDC, IRT, CTMS, ePRO, safety databases, and central labs flows into a unified evidence model.
- Data Harmonization: Normalizes heterogeneous data streams into a CDISC-aligned evidence schema (CDASH, SDTM, ADaM)
- Endpoint Tracking: Primary and secondary endpoints monitored in real time with automated interim analysis snapshots
- Signal Detection: Multi-factor safety signal analysis with severity weighting, auto-generated MedDRA coding, and narrative drafting for expedited reports
- Deviation Intelligence: Protocol deviation patterns clustered by site, investigator, and procedure — enabling proactive CAPA before systemic issues emerge
- Evidence Synthesis: Cross-source triangulation produces submission-ready evidence packages tailored to FDA, EMA, PMDA, and other regulatory authority formats
- Literature Integration: Real-time PubMed and clinical trial registry monitoring surfaces relevant external evidence for benefit-risk assessments
Architecture
The Unified Intelligence Architecture
Both engines connect through a single AI core that integrates with your existing trial tech stack. Every data point, every document, every signal — harmonized into one continuously validated source.
🔗 Trial Tech Stack — EDC · IRT · CTMS · ePRO · Safety DB · Central Labs
📄 eTMF Intelligence Engine — CDISC Reference Model · Auto-Classify · Continuous Monitor
🔬 Clinical Evidence Engine — Endpoints · Signals · Synthesis · Submissions
⚙ AI Core — Single Source of Truth
🛡 Compliance Layer — 21 CFR Part 11 · FDA · ICH/GCP · HIPAA · GDPR
The AI Core continuously ingests data from both engines and the connected trial tech stack. It cross-references eTMF completeness against clinical evidence milestones, validates compliance in real time, and surfaces the single unified view that sponsors, CROs, and regulatory teams need to make decisions with confidence — not guesswork.
Regulatory Compliance
Built for Inspection, Not Remediation
Every feature, every data flow, every AI decision is designed to meet the most stringent regulatory requirements from day one.
21 CFR Part 11
Electronic signatures, audit trails, access controls, and system validation per FDA requirements for electronic records.
FDA Guidance
Aligned with FDA guidance on AI/ML in drug development, including transparency, explainability, and human oversight.
ICH / GCP
ICH E6(R2) Good Clinical Practice principles embedded in every workflow — protecting subject rights and data integrity.
HIPAA
PHI safeguards, encryption at rest and in transit, BAA-ready architecture, and role-based access controls throughout.
GDPR / Privacy
Data minimization, subject consent tracking, right-to-erasure support, and EU data residency options built in.
CDISC Standards
eTMF Reference Model, CDASH, SDTM, and ADaM alignment for interoperability and regulatory submission readiness.
How It Works
From Integration to Intelligence in Weeks
A structured onboarding process connects your trial tech stack, configures both engines, and delivers value from the first automated review cycle.
Connect Your Stack
Secure API integrations with your EDC, IRT, CTMS, eTMF, safety database, and central labs. Validated connectors for all major platforms.
Configure the Engines
Map your eTMF to the CDISC Reference Model. Define endpoint tracking rules, signal thresholds, and site notification intervals.
AI Learns Your Trials
The AI Core calibrates to your document taxonomy, protocol structures, and evidence patterns. Human-in-the-loop validation ensures accuracy.
Continuous Intelligence
Auto-classification, continuous monitoring, site notifications, evidence synthesis, and compliance validation run 24/7 — freeing your teams to focus on science.
Partnership Opportunity
Ready to Unify Your Clinical Intelligence?
Whether you are a mid-market CRO, life sciences sponsor, or AI-forward biotech — let us show you how two engines become one source of truth for your entire clinical operation.
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