21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
GSRSSafety reporting
Safety reports generated directly from study data.
The Galax Safety Reporting System turns study safety data into review-ready reports. Upload raw EDC/CRF exports or SDTM datasets for a client and study, map them once with guided settings, choose the reports you need and download them with graphs in PDF or Word.
- Raw or SDTM
- Accepted input data
- AE · LB · ECG · VS
- Report families
- PDF + Word
- Download formats
Capabilities
Safety reports generated directly from study data.
5 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Client and study set-up
Organise work by client and study.
- Client → study structure
- Safety data uploaded per study
- 02
Data input
Work with the data you already have.
- Raw EDC/CRF exports
- SDTM datasets
- 03
Guided mapping
Map variables once, then reuse the settings.
- Settings screen for variable mapping
- Mapping reused for later uploads
- 04
Safety reports
The reports safety reviewers ask for.
- Adverse event reports
- Laboratory reports
- ECG and vital-sign reports
- Query reports
- 05
Graphs & downloads
Visual summaries alongside the tables.
- Graphs with each report
- Download as PDF or Word
How it works
One accountable path from set-up to evidence.
Galax Safety Reporting System runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Upload
Add raw CRF exports or SDTM datasets for the study.
- 02
Map
Confirm the variable mapping in settings.
- 03
Select
Choose the reports you need.
- 04
Download
Review graphs and download PDF or Word.
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
- Safety physician
- Medical monitor
- Data manager
- Sponsor
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax Safety Reporting
Regulatory safety reporting
$900per month
$10,800per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax Safety Reporting System on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.