Get
Clinical Trial
At
galaxbiotech.com
Galax Safety is our safety and pharmacovigilance platform designed to centralize case management and support global reporting. Capture ICSRs from multiple sources, perform medical review and manage follow-ups within a structured, audit-ready workflow. Standardized templates, validation rules and configurable checklists help your team work consistently and reduce compliance risk.
Powerful search and reporting tools let you explore trends across events, products, indications and regions. Integrated signal detection views highlight patterns that may need further investigation, while configurable outputs support PSURs, DSURs and other regulatory submissions. Galax Safety helps you protect patients while staying ahead of evolving safety requirements.
We transform safety data into clear, actionable insights for your teams.
Every capability your safety team needs — from case intake to signal detection to regulatory submission.
Capture individual case safety reports (ICSRs) from every channel — site reports, spontaneous reports, literature, regulatory authorities, and partner notifications. Automated triage routes cases based on seriousness, causality, and product familiarity. Duplicate detection prevents redundant processing.
Structured workflows guide case processors through every step — patient demographics, event details, product information, concomitant medications, and narrative. Configurable templates ensure consistency across cases. Validate data against rules, attach source documents, and manage follow-up inquiries with versioned narratives.
Physicians review cases with a dedicated medical assessment workflow. Assess causality, seriousness, expectedness, and company core safety information (CCSI). Medical review outputs flow directly into reporting and signal detection — with full sign-off and audit trail.
Code adverse events, medical history, and medications consistently with MedDRA and WHO Drug dictionaries. Verbatim terms flow into a structured queue where coders assign, reviewers approve, and every decision is tracked. Dictionary versioning supports recoding and regulatory alignment.
Generate CIOMS, MedWatch, and other regulatory forms with pre-populated case data. Submission tracking ensures timelines are monitored and documented. Integrated distribution workflows route reports to regulatory authorities, partners, and internal stakeholders.
Detect new safety signals through integrated analytics. Signal detection views highlight case patterns, with statistical support including disproportionality analysis and reporting rate comparisons. Structured signal evaluation workflows track signals from detection through validation, assessment, and recommendation.
Support RMP (Risk Management Plan) activities with integrated risk mapping and mitigation tracking. Link risks to products, populations, and reporting obligations. Monitor risk minimization actions and track effectiveness assessments over time.
Generate PSURs, DSURs, PADERs, and other aggregate reports with configurable data extracts and pre-built templates. Access case listings, line listings, summary tabulations, and narrative outputs — all with full traceability to source data.
Granular permissions control access to case data, reports, and system configuration. Role-based privileges for safety physicians, case processors, coders, medical reviewers, and regulatory reporting staff — with MFA-ready architecture and session controls aligned with safety data privacy expectations.
Every case action is recorded with user identity, timestamp, old and new values, and reason for change. Complete narrative version history preserves all case revisions. Designed to support 21 CFR Part 11, ICH E2B(R3), and global pharmacovigilance regulatory requirements.
Real-time visibility into safety operations: case volumes by seriousness and product, reporting timeliness against regulatory deadlines, coding backlog, medical review status, and signal detection activity. Configurable reports support performance monitoring and regulatory submission preparation.
Connect Galax Safety with your clinical data ecosystem. Seamless integration with Galax EDC for SAE reconciliation, Galax eTMF for safety document management, and LUP Analytics for statistical safety reporting. E2B(R3) and E2B(R3) XML exports support regulatory data exchange.
Safety signals emerge in the gaps — incomplete cases, aging submissions, unreconciled events. Galax Safety dashboards surface what matters:
97.4% within regulatory deadline
4 cases under review
Galax Safety is engineered around the regulatory expectations that govern drug safety monitoring worldwide.
Electronic records, e-signatures, audit trails, and access controls built into the platform architecture.
Structured case data supports E2B(R3) XML exports for regulatory exchange and global reporting.
Pre-populated regulatory forms with configurable templates for global regulatory authority submissions.
Complete audit trails, narrative versioning, and reason-for-change capture — with validation-friendly documentation for your CSV activities.
Compliance is a shared responsibility: Galax Safety provides the technical controls and documentation to support your regulated pharmacovigilance processes; certification claims are made only where formally established.