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LUP Analytics is our engine for clinical data analysis and reporting, giving you a Standard applications-style environment without the complexity. Using validated functions and statistical routines, your team can generate standard tables, listings and figures (TLFs) for safety and efficacy, compare treatment arms, and create ad-hoc summaries on demand. Outputs can be exported to Excel, Word or PDF, ready for medical writers and regulatory teams.
Behind LUP sits our CDISC SDTM conversion framework, which transforms raw EDC and external data into clean, standardised SDTM datasets. We apply controlled terminology, IG-specific rules and sponsor conventions so that data is consistent across studies and submission-ready. Because SDTM is built into the process, LUP can immediately consume these datasets and produce analysis-ready views, dramatically shortening the path from data capture to insights and reporting.
We convert raw trial data into CDISC-standard datasets and instant analytics.
End-to-end analytics and CDISC compliance — every capability your biostatistics team needs.
Ingest raw clinical data from EDC, labs, and external sources with validation and traceability. Automated mapping rules transform source data to SDTM domains, with custom logic for sponsor-specific conventions. Mapping specifications are versioned and reviewed to ensure consistency.
Transform raw data into CDISC SDTM domains (DM, AE, CM, LB, EX, etc.) with controlled terminology and IG-specific rules. Convert visit structures, incorporate derived variables, and maintain complete traceability from source to SDTM. Domain specifications and decision logs support submission readiness.
Build analysis-ready ADaM datasets (ADSL, ADAE, ADCM, ADLB, etc.) that follow CDISC ADaM standards. Support for common analysis structures including BDS, OCCDS, and ADSL. Implement company standard derivations and variable naming conventions for consistent analysis across studies.
Generate CDISC-compliant define.xml files that describe your study datasets. Include variable metadata, controlled terminology, derived variable logic, and dataset relationships. Machine-readable XML format with human-readable structure supports FDA and PMDA submissions.
Generate tables, listings, and figures (TLFs) for safety and efficacy endpoints using validated statistical routines. Standard output includes demographic summaries, adverse event tables, concomitant medication summaries, efficacy analyses, and patient listings. Configurable templates support sponsor-specific formatting.
Create custom summaries, cohort comparisons, and subset analyses on demand. User-friendly interface for selecting populations, variables, and statistics without extensive programming. Results can be exported as tables, figures, or data extracts for further exploration.
Implement standard statistical methods for clinical trial analysis: MMRM, ANCOVA, survival analysis, repeated measures, and more. Support for continuous, categorical, and time-to-event endpoints. Statistical outputs with standard diagnostics including p-values, confidence intervals, and effect sizes.
Create publication-quality figures including forest plots, Kaplan-Meier curves, waterfall plots, swimmer plots, and more. Interactive views support exploration and review. Customizable color palettes, labels, and annotation styles match sponsor and publication requirements.
Granular permissions control access to analysis datasets, outputs, and system configuration. Role-based privileges for biostatisticians, programmers, medical writers, and reviewers. Data masking and anonymization options support exploratory and blinded analyses.
Complete audit trail for all data transformations, analysis runs, and output generation. Records include user identity, timestamp, input datasets, code versions, and output parameters. Designed to support 21 CFR Part 11 and GxP-compliant analytical environments.
Study dashboards show SDTM and ADaM status by domain, define.xml readiness, and analysis output progress. Team dashboards track TLF completion against milestones. Automated notifications alert stakeholders when outputs are ready for review or require updates.
Connect LUP with your clinical data ecosystem. Seamless integration with Galax EDC for raw data, Galax eTMF for documentation, and Galax Safety for safety data. Exports to Excel, Word, PDF, and SAS-ready formats. API and web services support integration with external analytics tools.
Analytics and CDISC readiness tracked in real-time — from raw data to submission package:
3 domains in progress · 2 ADaM pending
Define.xml updates required
LUP is engineered to support CDISC standards and regulatory submission requirements.
SDTM conversion with controlled terminology, IG-specific rules, and complete traceability from source data.
Analysis datasets following CDISC ADaM standards with standard derivations and variable naming conventions.
Machine-readable and human-readable metadata documentation supporting FDA and PMDA submissions.
Statistical routines and code quality processes designed to support GxP-compliant analytical activities.
Compliance is a shared responsibility: LUP provides the technical controls, documentation, and validated environment to support your CDISC activities; certification claims are made only where formally established.