See full pipeline, ROI metrics, all studies.
Login as Study DirectorAI That Never Misses a Clinical Trial Follow-Up
ClinicalAI makes outbound AI voice calls to trial patients, captures protocol responses, auto-codes to MedDRA, and delivers a 21 CFR Part 11 compliant admin console — with 4 role-based personas for every pharma team.
Explore Every Pharma Role — Instantly
No signup. Click any role to log in directly to the live demo.
Work MedDRA coding queue, review flagged terms.
Login as Medical CoderReview calls, apply QC disposition, e-sign records.
Login as QC ReviewerManage your patient call queue, monitor live sessions.
Login as Site CoordinatorEverything Built. Nothing Missing.
12 platform capabilities — all live in the demo today.
Voice AI Agent
ElevenLabs-powered outbound voice with natural patient interaction.
Speech-to-Text
Real-time medical-tuned STT with custom vocabulary.
Clinical NLU
Extract symptoms, AEs, and protocol responses from free speech.
Call Orchestration
Twilio + SIP routing, retry logic, callback scheduling.
MedDRA Coding
Verbatim → PT/HLT/HLGT/SOC. SMQ screening. v27.x.
HSM Audit Trail
RFC 3161 timestamping, tamper-evident event log.
E-Signatures
21 CFR Part 11 §11.50 compliant signature manifest.
HIPAA + GDPR
AES-256 at rest, TLS 1.3, BAA + DPIA documentation.
Live Monitor
Real-time transcript, protocol tracker, AE detection.
Automated QC
PASS/FLAG/FAIL workflow with deviation register.
GAMP 5
Validated category 4 software, IQ/OQ/PQ ready.
Enterprise DR
Multi-region failover, encrypted snapshots, RTO < 1h.
Built. Not Mocked.
Every screen below is live in the demo at clinicalai.aideveloper.consulting
Compliance Isn't a Feature. It's the Foundation.
21 CFR Part 11
- HSM-backed audit trail with RFC 3161 timestamping
- E-signature manifest with countersignature workflow
- Role-based access control with re-authentication
- CSV (computer system validation) documentation available
- §11.10, §11.30, §11.50, §11.70 coverage
HIPAA + GDPR
- AES-256 encryption at rest, TLS 1.3 in transit
- Business Associate Agreement with all vendors
- Data Protection Impact Assessment documentation
- Data subject rights management (access, erasure, portability)
- Pseudonymization + audit logging of PHI access
GCP ICH E6 R2 + ALCOA+
- Protocol adherence tracking on every call
- Read-back confirmation for critical data points
- Immutable data capture — attributable, legible, contemporaneous
- Deviation register with root cause workflow
- Source data verification (SDV) ready exports
From Demo to Production — Phased Delivery
Interactive UX Prototype
Fully clickable role-based demo at clinicalai.aideveloper.consulting.
Working Voice Agent
Real outbound calls to test numbers. End-to-end transcript + MedDRA pipeline.
Full Production
HIPAA infra, MedDRA engine, EDC integration (Medidata, Veeva, Oracle).
Validation & Compliance
IQ/OQ/PQ documentation, FDA inspection readiness, periodic revalidation.
