MonitoHQThe Clinical Operations Hub
One eClinical platform for running clinical trials: CTMS, EDC, eTMF, eISF, IWRS, eConsent, monitoring, training and quality workflows in a single workspace. One login and one source of truth.
32 tools.15 workflows.One platform.
Every tool a monitoring team needs, built on the same records. A site, a patient or a document is defined once and used everywhere, so nobody has to re-enter it or reconcile it between systems.
Six logins, or one platform.
Most trials run on six systems with six audit trails, and a spreadsheet to fill the gaps between them. Here is what it looks like when the same work happens in one place.
One platform instead of six.
Including the tools usually sold as add-ons.
The eClinical tools sponsors and CROs expect, plus the operational tools that are usually bought separately: document repository, delegation log, safety-letter acknowledgement, site training and risk-based site management. You get all of it 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, including 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.
Sponsor, CRO and site all work from the same records, with permissions set per role, so a 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 and 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 records, 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.
These changes follow from keeping sites, patients and documents in one place instead of six.
Sponsor and CRO teams no longer switch back and forth 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, with no per-module billing and no overlapping seats.
Teams spend less time moving data between systems and more time on the trial.
The full workspace.
Grouped by study phase. Every module shares the same records, roles and audit trail.
eDelegation
Electronic delegation of authority. The PI signs, sub-Is acknowledge, and every version records its reason.
eBinder
The investigator site file, fully electronic and ready for inspection.
Smart Visit Calculator
Visit windows per patient. After an amendment, the whole 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 and searchable documents, reachable from any workflow.
Compliant ICF eSignature
Part 11 e-signature for consent, with each ICF version tracked and every re-consent flagged.
Patient Lifecycle
Screening to close-out on one timeline.
eCRF
Built-in data capture: forms, edit checks, queries and SDV.
IWRS
Randomization and IP: kit allocation, accountability and excursions.
eTMF
A trial master file on the DIA TMF Reference Model that fills itself as work is signed.
Configurable ISF Tracker
Configure the ISF index per study. Missing documents are flagged to the site and the eTMF.
Event Management
Monitoring visits run step by step, and the completed steps build the report.
Smart Lists
Action lists for each CRA, filled automatically from every module.
Quick Template Bank
Drop a template into an event and it picks up the study, site and patients.
Monito Scanning App
Scan documents with a phone. OCR reads them, then they are classified and routed.
Site Training Management
Assign site training centrally, track it, and require it before access.
Smart Notes
Notes attached to patients, sites and events show up in the report.
Payment Tracker
Site invoicing from completed milestones. Exportable to finance.
Smart eCRF Builder
Build and version eCRF forms without engineering.
Newsletters
Draft, review and send investigator newsletters, then collect acknowledgements.
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
Live enrollment, query, deviation and risk figures across the portfolio.
Risk-Based Site Management
RBQM-ready. Finds and ranks 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 exported as one timestamped Part 11 record.
AI is coming to MonitoHQ in three phases.
We are adding it slowly and with regulation in mind, on top of the trial data that already lives in MonitoHQ. Assistance comes first, autonomy last, and you can always see what the AI did.
Help in context, smarter search and auto-fill in every workflow. The monitor still makes every decision.
Flags and suggested next steps that point out risk, deviations and overdue work before they turn into findings.
Monitoring workflows run end to end by the AI, introduced only as far as regulations allow.
See your protocol running inside MonitoHQ.
30 minutes with a founder. Bring a real protocol and we'll show you what changes when monitoring lives in one place.