MonitoHQThe Clinical Operations Hub
One connected eClinical platform for clinical trial operations — CTMS, EDC, eTMF, eISF, IWRS, eConsent, monitoring, training and quality workflows in a single workspace. One login. One source of truth.
32 tools.15 workflows.One platform.
Every tool a monitoring team needs — connected, not bolted together. Built so that a site, a patient or a document is defined once and referenced everywhere, instead of re-entered and reconciled system by system.
One platform instead of six.
Including the tools usually sold as add-ons.
The core eClinical toolkit sponsors and CROs expect, plus the operational tools that usually arrive as separate purchases — document repository, delegation log, safety-letter acknowledgement, site training, risk-based site management. All in one platform, under one contract.
Every tool you used to juggle, in one workspace.
The same clinical trial systems, minus the reconciliation work between them.
- CTMS
- EDC
- IWRS
- eTMF
- LMS
- Safety inbox
- Delegation
- ISF tracker
- Trainings
- Safety letter acknowledgement
- Payment tracking
- Newsletter acknowledgement
- Patient visit tracker
- Six logins
- Six audit trails
- Nightly CSV syncs
- CTMS
- EDC
- IWRS
- eTMF
- LMS
- Safety inbox
+ 26 more modules in the same workspace — monitoring visits, eISF, eDelegation, training, safety letters, payments, analytics and risk.
- One login
- One audit trail
- Live across every module
From regulatory submission to archive.
MonitoHQ is already in use when you are building the submission package, and it is still what you export from at close-out.
- 01
Regulatory submission
Before a single site is open.
Building the package
- Package submission
- Document repository
- Version control
- 02
Site activation
Getting sites open, and knowing which ones are ready.
Startup
- Site document collection
- Contract agreement
- Budget forecasting
- eDelegation log
- Site training
- 03
Active phase
Enrolment, monitoring, safety and data capture — for the CRO and for the sites.
Enrolment & data
- CTMS
- eCRF
- IWRS
- Patient lifecycle
Monitoring
- Event management
- eISF tracker
- eBinders
- eDelegation log
Safety & communication
- Safety letters
- Newsletters
- Manuals
Oversight & admin
- LMS
- Document repository
- Package submission
- Payment tracker
- 04
Close-out & archive
Everything leaves in a form somebody else can read.
Exports
- Audit trail export
- Full eTMF
- Audit-trailed eCRF
- Patient adherence
Handover
- Data analysis
- Archiving
Your sites get a dashboard, not an inbox.
Most of what a coordinator has to do for a sponsor arrives as email and is remembered, or is not. In MonitoHQ the site opens a task list: a safety letter waiting for acknowledgement, training that a protocol amendment has just made necessary, a shipment on its way, a delegation line needing the PI's signature, a patient due for re-consent, a document the site file is missing.
The same entity graph underneath serves sponsor, CRO and site, with permissions applied per role — so the site sees its own work, and nothing else. Every action is signed, version-controlled and written to an exportable audit trail.
- Safety letter to acknowledgeSUSAR letter SL-2026-014 · due in 3 days
- New training assignedProtocol v4.0 · 2 staff outstanding
- Shipment expectedIP resupply · arriving Thursday
- Delegation line to signv6 · awaiting PI signature
- Re-consent required3 patients on ICF v3.0
- Site file document missingGCP certificate · S. Müller
One vendor instead of six. One contract. One login.
System composition
CTMS + EDC + IWRS + eTMF + LMS + safety inbox
One workspace · 32 tools · 15 workflows
Data flow
Nightly CSV syncs and middleware
Shared entity graph · live in every module
Site definition
Re-entered in six systems
Defined once · referenced everywhere
Audit trail
Spread across six vendors
One exportable 21 CFR Part 11 record
Identity
Provisioned per tool
Sponsor · CRO · site, role-aware throughout
Commercials
Per-module billing, one contract each
One implementation · one contract
What changes when it is one workspace.
Not a longer feature list — a different shape. These follow from sites, patients and documents living in one place instead of six.
Sponsor and CRO teams stop context-switching between six tools.
Structured workflows for delegation, ICF versioning and visit windows are designed to reduce common sources of protocol deviation.
One vendor instead of six. No per-module billing, no overlapping seats.
Less time spent moving data between systems, more spent on the trial itself.
The full workspace.
Grouped by phase. Every module shares the same entity graph, roles and audit.
eDelegation
Electronic delegation of authority. PI signs, sub-Is acknowledge — versioned with reason.
eBinder
The investigator site file, fully electronic. Always inspection-ready.
Smart Visit Calculator
Per-patient visit windows. Amend once — the cohort recomputes.
Training Review
Review and approve site training records at a glance.
Task Dashboard
Every open task, per site and per role, on one screen.
Manual Tracker
Track each site's read-acknowledgement of every manual version.
Doc Repository
Versioned, signable, searchable — reachable from any workflow.
Compliant ICF eSignature
Part 11 e-signature for consent. Every version, every re-consent, flagged.
Patient Lifecycle
Screening to close-out on one timeline.
eCRF
Native data capture — forms, edit checks, queries, SDV.
IWRS
Randomization and IP — kit allocation, accountability, excursions.
eTMF
A trial master file that fills itself. DIA TMF Reference Model.
Configurable ISF Tracker
Configure the ISF index per study. Missing-doc flags drive site and eTMF.
Event Management
Sequential monitoring-visit steps. The timeline drives the report.
Smart Lists
Auto-surfaced action lists per CRA, fed from every module.
Quick Template Bank
Drop a template into an event — inherits study, site, patients.
Monito Scanning App
Capture from phone — OCR, auto-classify, auto-route.
Site Training Management
Assign, track and gate site training centrally.
Smart Notes
Notes attach to patients, sites and events — and travel into the report.
Payment Tracker
Site invoicing from completed milestones. Exportable to finance.
Smart eCRF Builder
Build and version eCRF forms without engineering.
Newsletters
Investigator newsletters — draft, review, distribute, acknowledge.
Safety Letters
SUSAR and safety distribution with medical and regulatory sign-off.
Training Management
Author, assign and track protocol training across the study.
Report Tables
Operational tables and listings, ready to export.
Smart Event Report Builder
Monitoring reports assembled from completed visit steps.
Useful Links
Curated study resources, one click from every workspace.
Analytics
Enrollment, queries, deviations and risk — live across the portfolio.
Risk-Based Site Management
RBQM-ready. Surface and rank site risk signals.
User Account Creation
Onboarding with role and study scope in one flow.
Roles & Permissions
Admin · CTM · CRA · Site. Study-scoped, applied instantly.
Audit Export
Every change, one timestamped Part 11 record.
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.
In-context help, smart search and auto-fill across every workflow. The platform does the busywork; the monitor stays in control.
Proactive flags and next-best-action suggestions — surfacing risk, deviations and overdue work before they become findings.
Autonomous orchestration of monitoring workflows end-to-end — rolled out responsibly, only as regulations allow.
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.