21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
LABCentral and local laboratory data
Laboratory results, samples and lab safety in one controlled place.
Galax Lab Data manages central and local laboratory data for the study: laboratories, normal ranges and the test catalogue, results loaded from vendor files, eCDT transfers or manual entry, clinical-significance review, alerts, sample logistics and storage, data quality and lab safety review. It works directly on the subjects and visits of Galax EDC and produces the SDTM LB dataset.
- 3
- Ways to load results: file, eCDT or manual
- Live
- Critical and Hy's law alerts
- LB
- SDTM dataset produced from the module
Capabilities
Laboratory results, samples and lab safety in one controlled place.
7 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Laboratories & normal ranges
Register every central and local laboratory with its test catalogue and approved reference ranges.
- Laboratory register with certificates, manuals and the site–laboratory map
- Test catalogue with units and conversions
- Normal-range versions by sex and age, approved before use
- 02
Results & profiles
Load results and derive flags automatically, with a full subject view.
- Results from vendor files, accepted eCDT transfers or manual entry
- Load history with data issues listed per file
- High/low flags, toxicity grades and baseline derived consistently
- Subject lab profile across visits
- 03
Clinical significance & alerts
Investigators assess out-of-range values and sign their decision.
- Clinically significant / not significant assessment with e-signature
- Critical-value alerts routed to the right people
- Lab-related adverse events linked to the result
- 04
Samples, kits & storage
Follow every sample from requisition to destruction.
- Requisitions, accessions, recollection and shipping
- Expected versus missing samples and turnaround time
- Kit types, site inventory and resupply thresholds
- Storage box map, aliquots, chain of custody, future-use consent and retention
- 05
Data quality & reconciliation
Keep lab data consistent with the EDC and ready for lock.
- EDC–lab reconciliation with discrepancy work list
- Lab queries raised, answered and closed
- Data review checks and signed subject-visit review
- Lab data lock readiness
- 06
Lab safety review
Dedicated views for the safety signals that matter most in laboratory data.
- Liver safety with eDISH and potential Hy's law assessment
- Renal function, eGFR and acute kidney injury
- Potentially clinically significant values and toxicity-grade worsening
- Subject and cohort trend plots, shift tables
- 07
Vendor oversight
Measure laboratory performance against agreed targets.
- Vendor scorecard and KPI targets
- Vendor issues, CAPA and periodic reviews
How it works
One accountable path from set-up to evidence.
Galax Lab Data runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Set up
Add laboratories, the test catalogue and approved normal ranges.
- 02
Load
Bring in results from files, eCDT or manual entry and resolve data issues.
- 03
Review
Assess clinical significance, act on alerts and review lab safety.
- 04
Reconcile & lock
Reconcile with the EDC, close queries and sign data review complete.
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
- Data manager
- Investigator
- Medical monitor
- Lab coordinator
- CRA
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax Lab Data Management
Central and local laboratory data
$900per month
$10,800per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax Lab Data on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.