21 CFR Part 11 · HIPAA · Multi-tenant

Clinical trials,
orchestrated by AI.

Envision Trials unifies sponsors, CROs, and sites on one platform — with AI agents that handle feasibility scoring, patient matching, document assembly, and contract negotiation. Activate sites in weeks, not months.

73%
faster site activation
3.2×
patient match rate
40%+
agent autonomy target
7-yr
WORM audit trail
For Sponsors·For CROs·For Investigator Sites·For Auditors

Platform

One workspace. Every stakeholder.

Replace the patchwork of CTMS, EDC, eConsent, and Excel trackers with a single tenant-isolated platform purpose-built for modern clinical operations.

Site activation tracker

Visual pipeline from feasibility to first-patient-in. Automated alerts surface stalled milestones.

Patient matching engine

Ingest protocols, generate dynamic screening questionnaires, and score patient fit in real time.

eConsent & contracts

21 CFR Part 11 compliant signatures. Auto-generated CTAs with fair-market-value budgets.

Enrollment forecasting

Predictive timelines with confidence intervals. Alerts when projected enrollment slips.

Agent orchestration

LangGraph-powered agents with 3-layer guardrails and human-in-the-loop approval queues.

Immutable audit trail

Every change captured with user, timestamp, IP, before/after — stored WORM for 7 years.

AI Agents

A workforce of specialists for every trial workflow.

Each agent routes through a central orchestrator with guardrails, confidence thresholds, and explainable reasoning. Low-confidence outputs hand off to humans.

AG-01Feasibility

Ranks sites by protocol fit

AG-02Doc Assembly

Auto-generates FDA 1572

AG-03Patient Matching

Explainable eligibility scoring

AG-04Communication

Drafts weekly status reports

AG-05Analytics

Continuous anomaly detection

AG-06Doc Lifecycle

OCR expiry tracking & renewals

AG-07Contract Negotiation

FMV budgets + redline review

AG-08Site Prediction

Weekly health scores

AG-09Patient Retention

Dropout risk interventions

Compliance by default

Built for the regulators in the room.

MFA-enforced authentication, row-level multi-tenant isolation, and an immutable audit log capturing every mutation — exactly what 21 CFR Part 11 and modern HIPAA require.

  • AES-256 encryption at rest, TLS 1.3 in transit
  • US-only data residency for PHI / PII
  • WORM audit log with 7-year retention
  • RBAC across Sponsor, CRO, Site, PI, CRC, Auditor
  • SCIM provisioning for enterprise SSO
  • OWASP Top 10 scanning in CI/CD

Ready to operate trials at AI speed?

Spin up your organization workspace and invite your team. RBAC, audit logs, and the foundation agents are ready out of the box.