Monitoring

Clinical trial monitoring software for CRAs, CROs, sponsors and sites.

Prepare, visit, raise findings, assign actions, write the report, chase the follow-up. MonitoHQ runs the whole sequence in one place, on the same site, patient and document records the rest of the trial uses.

  • SQV / PSV
  • SIV
  • IMV
  • COV
  • Remote review
One monitoring visit
  1. 01Prepare from open actions
  2. 02Work the visit steps with smart checklists
  3. 03Raise findings
  4. 04Assign follow-up actions
  5. 05Assemble the report
  6. 06Carry actions forward

Every step writes to the records the next one reads.

The visit, end to end

One sequence, from preparation to closed action.

Each step writes to the same records the next step reads. Nothing is re-keyed between them.

  1. Prepare

    Opens with the site's open actions, ISF gaps, expiring documents and overdue training already listed.

  2. Visit

    Smart checklists per visit type drive the work — consent, SDV, IP accountability, site file, delegation.

  3. Findings

    Raised against a site, patient, visit or document — a tracked object, not a line in a PDF.

  4. Actions

    Each finding gets an owner and a due date, and stays open across visits until closed.

  5. Report

    Assembled from the completed steps and findings. The CRA signs, the study manager co-signs.

  6. Follow-up

    Open actions carry forward into the next visit's preparation step.

Global overview

Everything about a site, on one screen.

IWRS, delegation, ICF versions, the site file, eCRF, training, documentation and every past visit — one view instead of eight systems. It is also what the smart checklists draw on once you are on site.

Site 04 Berlin · ATX-204One screen · everything below is live

Patient

  • Patient journey142 enrolled · 18 screening
  • ICF versions8 need re-consent
  • eCRF & queries11 open · 2 aged
  • IWRS & IPKits in date

Site

  • Delegation logv6 · 1 acknowledgement due
  • eISF tracker3 missing · 3 expiring
  • Training records2 overdue
  • DocumentationCurrent

History

  • Past visits4 completed
  • Open findings3 · 1 major
  • Follow-up actions3 carried forward
  • Safety lettersAll acknowledged
1login, not eight
0systems to reconcile before you travel
Smart checklists adapted to the visit type turn this snapshot into the steps to work through on site

Illustrative data — not a real study.

What it covers

The parts of monitoring that usually need another tool.

Visit-type templates

SQV, SIV, IMV and COV each carry their own step sequence, configured per study.

Per-CRA action lists

Everything assigned to a monitor, across every site, on one screen.

Site file review in place

Check the eISF index during the visit. Missing-document flags become findings in place.

Delegation review

See who is delegated for what as of the visit date, and raise a finding if it does not match.

Document capture

Scan from a phone. Pages are classified and routed to the right site file section.

Assembled reports

Built from completed steps and findings, then edited and signed.

Notes that travel

Notes attach to a patient, site or visit and surface in the report.

Co-signature

CRA signature and study-manager or PI co-signature, each with a timestamped audit entry.

Risk-weighted targeting

Risk signals feed visit planning, so effort follows risk, not the calendar.

Common questions

Which visit types does MonitoHQ support?

Site qualification (SQV/PSV), site initiation (SIV), interim monitoring (IMV) and close-out (COV). Each visit type carries its own step sequence and template, configured per study, so an SIV agenda and an IMV agenda are not the same checklist with different titles.

Can CRAs work during a visit without connectivity?

The scanning app captures documents from a phone and uploads them once a connection is available. Report drafting happens in the browser and requires connectivity.

Does the monitoring report have to be written from scratch?

No. The report is assembled from the steps already completed during the visit — patients reviewed, documents checked, findings raised and actions assigned. The CRA edits and signs rather than transcribing.

How do findings become follow-up actions?

A finding is raised against the site, and optionally against a specific patient, visit or document. It carries an owner, a due date and a status, and it stays open across visits until it is closed — so the next IMV opens with the previous visit's outstanding actions already listed.

Is this suitable for remote or centralised monitoring?

Yes. Because the eISF, delegation log, training records and eCRF data sit in the same platform, a monitor can review site documents and data remotely and record that review as part of the same visit record used for on-site work.

Demo

Bring a monitoring visit you ran last month.

30 minutes with a founder. We'll walk your real visit through the workflow — preparation, findings, actions, report — and you can judge how much of it disappears.