Clinical Study Management · AI-assisted

From protocol to data lock, in one intelligent console.

Workflow-driven, metadata-first clinical operations. Design protocols, activate sites, manage subject lifecycle, capture eCRFs and lock data — together with sponsors, investigators and CRCs.

ICH-GCP aligned21 CFR Part 11 readySite + Sponsor in one placeAudit-traceable
Lifecycle map

Protocol → Sites → Subjects → Visits → Lock

Live KPIs

Enrollment, queries, monitor backlog

Governance

Roles, delegation, e-signature

Built for sponsors, CROs, hospitals & investigators
Phase I–IV· Multi-site· Multi-arm· Decentralised· Real-world
Outcomes

A measurable shift in how clinical operations run.

0%
Faster site activation
from feasibility to first subject
0×
Fewer protocol deviations
via visit-window guardrails
0h
Avg query closure
down from 6 days industry baseline
0%
Audit-trace coverage
every action, signed & timestamped
Platform

One console for every role across the study.

Sponsor admin, project manager, monitor, data manager, statistician, PI and CRC — everyone works on the same metadata, scoped by role and site.

Protocol Builder

Sections, schedule of activities, eligibility, eCRF blueprint — versioned with section-level approvals.

Site Activation

Hospital onboarding, doctor & CRC delegation, training records, site readiness gates.

Subject Lifecycle

Screening, consent, eligibility, randomisation, visits, completion — all traceable.

eCRF Capture

Designer + runtime with edit checks, queries, source verification and data review workflows.

Monitoring

Visit scheduling, findings, follow-ups and dual-control verification with electronic signatures.

Data Lock

Lock candidates, snapshot integrity, soft-lock & hard-lock gates with full audit.

Workflow Engine

Define states, transitions and approvals declaratively — no code changes.

Live Analytics

Enrollment funnels, site performance, query aging, data completion — refreshed live.

Sponsor + Site Portal

Single tenant for sponsor staff; scoped workspace for each investigator site.

Lifecycle

Every stage, modelled. Every transition, signed.

01
Protocol
02
Sites
03
Subjects
04
Visits & eCRF
05
Monitor
06
Lock & Report
Compliance

Designed for regulated trials, from day one.

Every interaction is traceable. Roles, delegation logs, e-signatures and immutable snapshots are built into the data model — not bolted on.

  • ICH-GCP, 21 CFR Part 11 & EU Annex 11 aligned
  • Section-level approvals with dual control
  • Tamper-evident audit trail on every record
  • Encrypted at rest, in transit and per-tenant
SIGNEDProtocol v2.1 — accepted by Hospital #04
LOCKEDSubject 0007 · Visit 3 · Page 12/12
RESOLVEDQuery Q-1183 — DM ↦ CRC ↦ closed
APPROVEDSite activation gate · 4 of 4 ✓
Product stories

Short briefs from the field.

Three perspectives — Sponsor, Site, Monitor — on what changes when the lifecycle lives in one place.

Sponsor

From protocol PDF to live study in days

A Phase II sponsor team replaced 14 spreadsheets and three tools with one console — protocol authoring, eCRF blueprint and site activation gates, all versioned and signed.

−62%time-to-first-subject
Investigator site

CRCs that never miss a visit window

Sites use the scoped portal to screen, consent and run visits with built-in eligibility checks, edit checks and source verification. Queries resolve in hours, not days.

48havg query closure
Monitor & QA

Risk-based monitoring without the spreadsheets

Monitors land on prioritised findings, sign verifications with dual control, and watch deviation trends across sites — every action timestamped to a person.

99%audit-trace coverage
Talk to us

See medcliniq.ai on your protocol.

Tell us about your study — we'll show you the console mapped to your indication, sites and visit schedule, and answer your compliance questions.

  • 30-minute guided walkthrough of the lifecycle
  • Live Q&A with a clinical operations lead
  • No procurement commitment to evaluate

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Run your next study on medcliniq.ai

Open the console, walk through a live protocol, and see the lifecycle in motion.