21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
SMSite management and monitoring
Site management from feasibility to close-out.
Galax Site Monitoring covers site start-up and activation, site staff and the delegation log, monitoring visits and visit reports, action items, site quality, essential documents and site performance. It works on the same studies, sites and subjects as Galax EDC and reads EDC, IWRS, Safety and eTMF data without changing it.
- End-to-end
- Feasibility to close-out
- Reviewed
- Visit reports approved or returned
- CAPA
- Root cause and effectiveness checks
Capabilities
Site management from feasibility to close-out.
8 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Feasibility & start-up
Select the right sites and activate them on time.
- Feasibility questionnaires with scoring and selection decision
- Start-up milestones and the site view
- Activation checklist and site activation
- 02
Site staff & training
Keep the delegation log and credentials current.
- Site staff, GCP training and credentials
- Investigator sign-off of the delegation log
- Amendments, letters and the training matrix
- 03
Visit planning
Plan every monitoring visit with the right preparation.
- Planning, rescheduling and cancelling visits
- Confirmation letters and monitoring calendar
- Trip planning and pre-visit pack
- 04
Visit conduct
Record what was checked at the site.
- SDV and source review
- Informed consent verification
- Investigational product accountability
- Investigator site file review and visit findings
- 05
Visit reports
Write, review and follow up every visit report.
- Visit reports submitted for review
- Approve or return with comments; report versions and timeliness
- Follow-up letters and visit documents
- 06
Quality & deviations
Resolve site issues at the root.
- Action items, communications log and site issues
- Root cause analysis, CAPA and effectiveness checks
- Escalation matrix
- Protocol deviations, monitor review and repeat-deviation trends
- 07
Documents & close-out
Stay inspection-ready to the last visit.
- Essential documents tracker and document requests
- ISF / eTMF reconciliation
- Inspection readiness and audit log
- Site close-out
- 08
Performance
See which sites need attention.
- Site scorecard, heat map and plan compliance
- Monitoring level suggestions
- Recruitment against target and pre-screening
- Monitor workload and site assignments
How it works
One accountable path from set-up to evidence.
Galax Site Monitoring runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Select
Send feasibility questionnaires and choose sites.
- 02
Activate
Complete start-up milestones and the activation checklist.
- 03
Monitor
Plan, conduct and report monitoring visits.
- 04
Resolve
Close action items, deviations and CAPA.
- 05
Close out
Reconcile documents and close the site.
Quality and control
Designed for regulated clinical work.
Platform controls and documented procedures support the sponsor's validated, risk-based use.
Role-based access
Each role sees only the screens and actions it is permitted, per environment.
Tamper-evident audit trail
Every change is attributable, time-stamped and kept with before and after values.
Validated deployment
Released under documented IQ/OQ/PQ, on-premise or in your cloud.
Who uses it
- CRA
- Lead CRA
- Clinical project manager
- Investigator
- Quality assurance
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax Site Monitoring / RBQM
One licence covers Site Monitoring and RBQM
$1,500per month
$18,000per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax Site Monitoring on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.