Data ingestion & mapping
Ingest EDC, laboratory and external data with validation, versioned mapping specifications and source-to-target traceability.
Analytics and standards
From raw trial data to submission-ready insight.
A clinical data analysis and reporting environment that combines CDISC transformation with validated statistical routines. Build SDTM and ADaM datasets, generate standard or ad-hoc TLFs and deliver controlled outputs for medical writing and regulatory teams.
LUP Analytics & CDISCAnalytics and standards
- 01IngestValidate raw data from EDC, labs and external providers.
- 02StandardizeCreate SDTM, ADaM and supporting metadata with traceability.
- 03AnalyzeRun controlled methods and create standard or ad-hoc outputs.
- 04DeliverExport reviewed datasets, TLFs and submission documentation.
Quality controlsConfigured, reviewed, traceable
Standardize, analyze and report through one traceable workflow.
SDTMStandards conversion
ADaMAnalysis-ready datasets
TLFsValidated reporting outputs
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.
SDTM conversion
Transform raw data into standard domains using controlled terminology, implementation-guide rules and documented decisions.
ADaM generation
Create analysis-ready ADSL, BDS and OCCDS structures with standard derivations, naming conventions and independent review.
Define.xml production
Generate structured metadata describing datasets, variables, controlled terminology, relationships and derivation logic.
TLF generation
Produce safety and efficacy tables, listings and figures from configurable templates using controlled statistical routines.
Analysis oversight
Track dataset readiness, output progress and review milestones while retaining run parameters, versions and audit records.
Delivery workflow
One accountable path from setup to evidence.
Connect LUP with Galax EDC for source data, eTMF for documentation and Galax Safety for integrated safety analysis, with Excel, Word, PDF and SAS-ready outputs.
Ingest
Validate raw data from EDC, labs and external providers.
Standardize
Create SDTM, ADaM and supporting metadata with traceability.
Analyze
Run controlled methods and create standard or ad-hoc outputs.
Deliver
Export reviewed datasets, TLFs and submission documentation.
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.
CDISC SDTM aligned
Controlled terminology, implementation-guide rules and complete source traceability support standardization.
ADaM compliant workflows
Analysis datasets follow standard structures with documented derivations and naming conventions.
Define.xml documentation
Machine-readable and human-readable metadata supports regulatory review and data navigation.
Validated environment
Audit trails, versioned programs and quality controls support reproducible GxP analytical activities.
The connected suite
Contact
See how LUP 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