MonitoHQ · Clinical Operations Hub

MonitoHQ

One tool. One login. All the monitoring.

You won't need anything else.

See all 32 tools
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Connected tools
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Workflows
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Platform
21 CFR
Part 11 aligned
Built for regulated trials
ICH-GCP E6(R3)· 21 CFR Part 11· EU CTR 536/2014· HIPAA· GDPR· ISO 27001 aligned· Annex 11· SDTM-compatible· RBQM-ready· ICH-GCP E6(R3)· 21 CFR Part 11· EU CTR 536/2014· HIPAA· GDPR· ISO 27001 aligned· Annex 11· SDTM-compatible· RBQM-ready·
The platform

32 tools. 15 workflows. One platform.

Every tool a monitoring team needs — connected, not bolted together. Purpose-built to prevent protocol deviations and eliminate over-clicking, so teams move faster with fewer errors.

32
Connected tools
Each purpose-built, none redundant
15
Orchestrated workflows
Tools chained into real monitoring work
1
Powerful platform
One login · one source of truth
What one platform eliminates
Multiple logins Wasted time Manual errors Protocol deviations Over-clicking
One destination

Every tool you used to juggle, converging into one.

Product

A few of our workflows in more details.

Sites, patients, events, signatures — flowing through every workflow. Real screens, illustrative data.

app.monitohq.com / studies / ATX-204 / patients
Patient roster
142 enrolled · 18 screening · Site 04 Berlin
Sort: visit window Filter: on-treatment
Patient ID Status Current visit Next visit ICF Queries
04-0028On-treatmentV5 · Week 12V6 · Mar 14v3.1 signed0
04-0031On-treatmentV4 · Week 8V5 · Mar 06 ⚠v3.1 signed2
04-0033ScreeningSCR-2SCR-3 · Mar 09pending0
04-0034RandomizedV1 · BaselineV2 · Mar 12v3.1 signed1
04-0036Withdrawnv3.0 signed0
04-0038On-treatmentV3 · Week 4V4 · Mar 21re-consent0
04-0041On-treatmentV2 · Week 2V3 · Mar 28v3.1 signed0
04-0044RandomizedV1 · BaselineV2 · Apr 03v3.1 signed0
Architecture

One graph. One audit. One identity layer.

Every module reads and writes the same entity graph. Identity, permissions and audit are primitives — not bolt-ons.

  • 01Unified entity graph. No shadow copies.
  • 02Live by default. Dashboards update without a refresh.
  • 03Role-aware end-to-end. Sponsor / CRO / site boundaries enforced uniformly.
  • 04Compliance baked in. E-signatures, version history, audit exports.
Data flow · workspace topology
Identity
Sponsor · CRO · Site users · Roles
Audit & e-signature service
21 CFR Part 11 · Annex 11
Modules · read/write to shared graph
Sites
Personnel
Delegation
Patients
Visits
Events
ICF
Training
IP / IWRS
EDC
ISF
eTMF
Safety
Newsletters
Payments
Manuals
Templates
Repository
Core
Entity graph · Reactive subscriptions · Postgres / RLS
Legacy stack vs MonitoHQ

One vendor instead of six. One contract. One login.

Dimension Legacy stack MonitoHQ Hub
System compositionCTMS + EDC + IWRS + eTMF + LMS + safety inbox + spreadsheetsOne workspace · 32 tools · 15 workflows · zero vendor handoffs
Data flowNightly CSV syncs, brittle middlewareShared entity graph · live state across every module
Site definitionRe-entered in 6 systemsDefined once · referenced everywhere · updates propagate instantly
Audit trailSpread across vendorsSingle, exportable 21 CFR Part 11 record · one export, one report
IdentityPer-tool provisioningSponsor · CRO · site model unified · role-aware in every module
Implementation9-month onboardings · per-module billingWeeks to onboard · single contract · transparent pricing
Operational riskEach vendor's outage is your outageOne platform · one team to call · one SLA
Results

Time saved. Quality up. Cost down.

One workspace doesn't just simplify the org chart. It compounds — across hours, quality, dollars and team morale.

01
One login = hours back

Sponsor and CRO teams stop context-switching between six tools.

02
Deviations stopped at the source

Workflows like eDelegation log and eICF guidance prevent most common protocol deviations.

03
One contract, one bill

One vendor instead of six. No per-module billing, no overlapping seats.

04
Teams focus on what matters

Less admin overhead, more time on patient safety and data quality. Happier monitors, higher retention.

Sponsors run leaner. Data is cleaner. Patients are safer.
Modules · 32 connected tools

The full workspace.

Grouped by phase. Every module shares the same entity graph, roles and audit.

Roadmap · AI Coming soon

Stay tuned for our smooth AI implementation.

Deliberate, regulation-first, and built on the one place where all your trial data already lives. No black boxes — assistance before autonomy.

Phase 1 2027
AI assistance

In-context help, smart search and auto-fill across every workflow. The platform does the busywork; the monitor stays in control.

Phase 2 2028
AI suggestion

Proactive flags and next-best-action suggestions — surfacing risk, deviations and overdue work before they become findings.

Phase 3 Subject to regulation
AI orchestrator

Autonomous orchestration of monitoring workflows end-to-end — rolled out responsibly, only as regulations allow.

Demo

See your protocol running inside MonitoHQ.

30 minutes with a founder. Bring a real protocol — we'll show what changes when monitoring lives in one place.

Reach the team