21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
PVPharmacovigilance
Case processing from intake to regulatory submission.
Galax Safety Database is the pharmacovigilance application of the Galax platform. It books in individual case safety reports, takes them through data entry, medical review, quality review and approval, assesses SUSARs, plans and tracks regulatory submissions, and supports reconciliation with the EDC, signal detection and periodic reports. It works on the same studies, sites and subjects as Galax EDC.
- E2B(R3)
- ICSR import and export
- Day 0
- Expedited reporting clocks
- AS2 / SFTP / API
- Regulatory gateway
Capabilities
Case processing from intake to regulatory submission.
8 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Case intake
Book in cases from every source.
- New cases booked in manually
- Cases created from EDC serious adverse events
- E2B(R3) import with mapping preview, validation and duplicate check
- Intake registry with source documents and extraction review
- Duplicate search, scoring and decision
- 02
Case processing
Structured data entry through to a locked version.
- General, products, history and lab data entry
- Adverse events with MedDRA coding
- Narrative and sponsor comment
- Medical review and quality review with e-signature
- Approval and version lock; follow-ups and nullification
- 03
Assessment & unblinding
Seriousness, causality and expectedness assessed consistently.
- Seriousness, causality and expectedness
- SUSAR identification on an expedited clock from day 0
- Controlled unblinding of a suspected SUSAR
- 04
Workload & quality
Keep every case moving and on time.
- My worklist; assign, take and release cases
- Priority, step deadlines and work settings
- Case validity and completeness score
- Comparison of case versions
- 05
Special situations
Targeted follow-up for the cases that need it.
- AESI list and case flags
- Pregnancy follow-up
- Follow-up requests, attempts, reminders and responses
- 06
Reporting & submissions
Plan, transmit and track every report.
- Regulatory submissions and investigator and EC notifications
- Distribution, acknowledgements and reminders
- Gateway profiles for AS2, SFTP or HTTPS API with MDN and acknowledgement handling
- DSUR and periodic reports
- 07
Signals & reconciliation
See the aggregate picture and keep data aligned with the EDC.
- Aggregate data and signal tracking
- Signal detection
- EDC–Safety reconciliation and final reconciliation
- 08
Automated assistance
Faster intake and drafting, with every result reviewed.
- Automated extraction of source documents at intake
- Narrative drafting with review and comparison
- Case QC with a final approval panel
- Inspection view
How it works
One accountable path from set-up to evidence.
Galax Safety Database runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Intake
Book in the case, check validity and duplicates.
- 02
Process
Enter data, code events and write the narrative.
- 03
Assess
Medical review, causality, expectedness and SUSAR clock.
- 04
Approve
Quality review, approval and version lock.
- 05
Report
Submit through the gateway and track acknowledgements.
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 associate
- Medical reviewer
- Safety QC
- PV manager
- Data manager
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax Safety Database
Pharmacovigilance case management
$2,400per month
$28,800per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax Safety Database on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.