The Galax System
Every module your study needs, built by one team.
17 validated modules across capture, operations, analytics, safety, regulatory and quality. Deploy one for a single study, or connect the whole system so data, documents and decisions share one audit trail.
- Modules
- 17
- Domains
- 4
- Audit trail
- 1
- Compliance
- 21 CFR Part 11 · GAMP 5
Stages 01–02 · Start-up & conduct
Data capture & trial operations
Collect clean data, randomise and supply, and run the study from one controlled foundation.
9 modulesGalax EDC & eCRF
Multi-tenant electronic data capture from protocol to database lock.
- Global, client and sponsor form and study-schema libraries
- Edit checks, derivations, query lifecycle, SDV, medical review and PI signature
- Role- and mode-based sign-in across EDC, IWRS, ePRO, eTMF, Safety, Lab, eCDT, RBQM and Site Monitoring
- PDF and Word CRFs: single form, blank study and visit-wise
Galax IWRS
Randomisation and trial supply in one controlled workflow.
- Screening, randomisation schemas and subject allocation
- Dose-escalation study support
- Kit preparation, inventory, depots and shipments
- Envelope view and emergency unblinding
Galax ePRO
Patient-reported outcomes captured as part of the evidence chain.
- Assessment configuration and participant schedules
- Guided patient data capture
- Completion oversight and data review
- Connected export to the study database
Galax Lab Data
Central and local laboratory data, samples and lab safety.
- Laboratories, test catalogue and approved normal-range versions
- Result loading with flags, toxicity grades and clinical significance sign-off
- Samples, kits, storage and chain of custody
- EDC–lab reconciliation, eDISH and Hy's law alerts
Galax eCDT
Electronic clinical data transfer from external vendors.
- Data transfer agreements and variable specifications
- Automatic transfer checks, findings and vendor issues
- EDC reconciliation and SDTM mapping
- Transfer calendar, vendor scorecard and data cut-offs
Galax RBQM
Risk-based quality management aligned with ICH E6(R3).
- Risk register (RACT), critical data and processes
- KRIs, QTLs and central statistical monitoring
- Targeted SDV/SDR strategy with adaptive triggers
- Quality and risk plan, risk review meetings and Site 360
Galax Site Monitoring
Site management and monitoring from feasibility to close-out.
- Feasibility, start-up, activation and delegation log
- Visit planning, conduct, reports and follow-up letters
- Action items, issues, root cause and CAPA
- Site scorecards, essential documents and close-out
Galax CTMS
Clinical trial management across the study portfolio.
- Portfolio, milestones, enrolment plans and forecasts
- Gantt timeline, critical path and slip report
- Site start-up, regulatory and ethics submissions
- Budgets, change orders, invoices and site payments
Galax eTMF
Trial Master File on the TMF Reference Model, inspection-ready by design.
- Zone, section and artifact tree with expected-versus-filed completeness
- Draft → review → approval → authorisation → final lock workflow
- E-signatures with mandatory reasons
- Bulk metadata, drag-and-drop upload, threaded queries
Stage 03 · Analysis
Analytics, standards & AI
Turn collected data into SDTM, analysis datasets, statistics and submission-ready outputs.
2 modulesGalax LUP
Clinical statistical programming on GLX, from raw data to signed-off TLFs.
- GLX language with Code, Visual, Graphical and Guided views
- SDTM conversion with a drafted, reviewable SDA mapping
- Demographics, disposition, AE, findings, shift and frequency tables
- NCA, BE (ABE, RSABE, ABEL, NTI), dose proportionality, compartmental and population PK
Galax Gen AI
Generative AI for biostatistics and clinical data (Module in Training stage).
- Support for SAPs, data review, SDTM/ADaM and TLFs
- Programming help in SAS, R, Python and GLX
- PDF-to-Excel data extraction
- Chat interface with user and admin panels
Stage 04 · Safety & quality
Safety, quality & compliance
Report safety, manage quality and keep people qualified, all under GxP control.
4 modulesGalax Safety Database
Pharmacovigilance case processing from intake to submission.
- Cases from EDC SAEs or E2B(R3) import, with MedDRA coding
- Medical and quality review, SUSAR clocks and expedited reporting
- AS2, SFTP or HTTPS gateway submissions with acknowledgements
- DSUR, periodic reports and signal detection
Galax Safety Reporting System
Safety reports generated directly from study data.
- Accepts raw EDC/CRF exports or SDTM datasets
- Guided mapping, then report selection
- Adverse event, laboratory, ECG and vital-sign reports, plus query reports
- Graphs, PDF and Word downloads
Galax eQMS
Electronic quality management system for regulated operations.
- FMEA risk management with severity × occurrence × detection scoring
- Controlled document storage
- Deployable on-premise or in the cloud
Galax TMS
GxP training management with Part 11-style e-signatures.
- Training materials, question banks and scored assessments
- Assignments by department, designation or group
- Instructor-led sessions with attendance and trainer sign-off
- Job descriptions and versioned CVs
Stage 05 · Submission
Regulatory submissions & information
Plan, publish and track submissions, and keep product registrations and labels under control.
2 modulesGalax eCTD Publishing
Regulatory submissions from content plan to archive.
- Content plans from CTD templates with gap view
- Sequence builder, study tagging files and generated XML
- Document QC, review cycles, validation and publishing
- Gateway acknowledgements, archive export and eCTD v4.0 readiness
Galax RIM
Regulatory information management for products and registrations.
- Product master, registrations and regulatory activities
- Health-authority questions, commitments and change control
- CCDS versions, local labels and periodic reporting calendar
- Manufacturing sites, GMP evidence and IDMP product data
Galax System core
One validated foundation under every module.
Shared services are built once and validated once, so adding a module never adds a new login, role model or audit trail.
IAMIdentity & single sign-onRBACRoles & permissionsESIGElectronic signaturesAUDITHash-chained audit trailMETAShared study metadataENVValidated environments
See it working
Choose the modules that fit your protocol.
Tell us the study design and the gaps you need covered. We will demonstrate the relevant modules and propose a configuration and validation approach.