Study setup & metadata
Configure countries, sites, visits and unscheduled events through a structured, metadata-driven setup with reusable form libraries and controlled amendments.
Clinical data capture
Clean clinical data—from protocol to database lock.
A flexible electronic data capture platform built for global clinical trials. Configurable eCRFs, reusable libraries and controlled versioning help study teams move from protocol to first patient in weeks, while intuitive forms and real-time checks improve data quality at entry.
Galax EDC & eCRFClinical data capture
- 01InterpretTranslate protocol objectives and schedules into a controlled data strategy.
- 02ConfigureBuild eCRFs, validations, roles, reports and integrations.
- 03ValidateExecute documented review and UAT before production release.
- 04Operate & lockMonitor, clean, reconcile and close the database with traceability.
Quality controlsConfigured, reviewed, traceable
Capture data that is clean, compliant and ready for analysis.
WeeksProtocol-to-go-live target
12Connected lifecycle modules
CDISCAligned data structures
Capabilities
Purpose-built for the clinical workflow.
Product capabilities are organized around the work study teams need to control, review and deliver—not around disconnected technical features.
eCRF builder
Design protocol-exact forms with conditional logic, calculated fields, repeating forms and a site-view preview for controlled UAT approval.
Clinical data capture
Guide sites through visit-wise entry, partial saves, structured missing-data reasons, clear form states and integrated SDV/SDR workflows.
Edit checks & queries
Apply field, cross-form and visit-level validation with a structured query lifecycle, aging views and clear ownership through resolution.
Coding, labs & safety
Support MedDRA and WHO Drug coding, central and local laboratory data, range flagging and AE/SAE review within the data workflow.
Oversight & export
Track enrollment, completion, query aging and lock readiness; export Excel, CSV and SAS-ready data in CDISC-aligned structures.
Delivery workflow
One accountable path from setup to evidence.
Connect Galax EDC with IWRS, eTMF, ePRO/eICF, Galax Safety and LUP Analytics for one continuous evidence workflow.
Interpret
Translate protocol objectives and schedules into a controlled data strategy.
Configure
Build eCRFs, validations, roles, reports and integrations.
Validate
Execute documented review and UAT before production release.
Operate & lock
Monitor, clean, reconcile and close the database with traceability.
Quality and control
Designed for regulated clinical work.
Platform controls and documented operating procedures work together to support the sponsor's validated, risk-based use.
21 CFR Part 11 support
Electronic records, e-signatures, audit trails and controlled access are built into the platform architecture.
ICH-GCP aligned
Controlled workflows and documented investigator oversight support regulated trial conduct.
GxP & ALCOA+ principles
Data controls support attributable, legible, contemporaneous, original and accurate records.
Inspection readiness
Versioned metadata, reason-for-change capture and access records remain available for review.
The connected suite
Contact
See how EDC fits your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.
info@galaxbiotech.com