21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
CTMSClinical trial management
Portfolio, timelines, sites and finance across every study.
Galax CTMS manages every study of the organisation: portfolio and health, milestones and the study timeline, enrolment against plan and forecasting, countries, site start-up and contracts, regulatory and ethics submissions, finance and site payments, budget control, vendors, the study team, meetings and the RAID log. Payment runs, budget versions and change orders are approved by a second person with a Part 11 e-signature.
- Portfolio
- Every study in one view
- Two-person
- Approval of payments and budgets
- What-if
- Timeline and enrolment scenarios
Capabilities
Portfolio, timelines, sites and finance across every study.
8 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Portfolio & study planning
One view of every study and its health.
- Portfolio with study health
- Study profile, milestones and imported CTMS milestones
- Enrolment plan and enrolment against plan
- Countries and the country plan
- 02
Timeline & critical path
Plan the work and see what slips.
- Gantt timeline with tasks, milestones and dependencies
- Critical path and slack
- Baseline and slip report
- What-if: shift a task and see the effect
- 03
Enrolment forecasting
Compare scenarios before you commit.
- Enrolment forecasting scenarios
- Saving and comparing scenarios
- 04
Sites & submissions
From start-up to approvals.
- Site start-up pipeline and cycle times
- Site contract and budget negotiation
- Regulatory and ethics submissions with decisions
- Questions from authorities and committees; renewals and reminders
- 05
Finance & site payments
Control spend at study and site level.
- Budget against actual
- Vendor invoices and payment schedule
- Site accruals, retention and payment runs
- Site payments across all studies
- 06
Budget control
Versioned budgets with controlled changes.
- Budget versions: baseline and revisions
- Budget change orders
- Burn and cost forecast
- 07
Vendors
Contracts, deliverables and performance.
- Vendors and the scorecard
- Vendor contracts and change orders
- Deliverables and milestones of a contract
- Contract invoices and expiring contracts
- 08
Team, meetings & RAID
Run the study team in the same system.
- Study team, resources and capacity
- Meetings with agenda, minutes, decisions and actions
- Minutes signed as final
- RAID log
How it works
One accountable path from set-up to evidence.
Galax CTMS runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Plan
Set milestones, the timeline, enrolment plan and budget baseline.
- 02
Start up
Track site start-up, contracts and submissions.
- 03
Run
Follow enrolment, forecast and manage the team and RAID log.
- 04
Control
Approve payments, change orders and budget revisions.
- 05
Report
Portfolio analytics, status reports and study workbook.
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
- Clinical project manager
- Study finance
- Clinical operations lead
- Sponsor
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax CTMS
Clinical trial management
$1,800per month
$21,600per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax CTMS on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.