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Biostatistics, CDISC Standards & Regulatory Submissions

Regulatory-Ready Clinical & Pharmaceutical SAS Programming

End-to-end biostatistical programming and CDISC data standardization tailored for audit-ready compliance, precision, and global regulatory review across Phase I–IV trials. We deliver fully verifiable, reproducible analytics and submission packages supporting pharma, biotech, biosimilar, and generic development programs for FDA, Health Canada, EMA, and PMDA submissions.

Core Practices & Capabilities

Biostatistical Consulting & Analytics

Comprehensive protocol design, statistical power and sample size determination, SAP authoring, randomization schedules, interim safety evaluations, DMC/DSMB reporting packages, and integrated summary analyses.

Study Design SAP Development DMC / DSMB Integrated Analyses

Pharmaceutical & Bioequivalence Statistics

Statistical methodologies for PK/PD profiling, Average Bioequivalence (ABE/RSABE), comparative dissolution kinetics (f2 testing), population bioequivalence (PBE), stability curve modeling, and shelf-life forecasting.

Bioequivalence (ABE/RSABE) PK / PD Analysis Dissolution & f2 Stability Studies

Clinical Data Management

End-to-end data stewardship spanning study startup, eCRF specification, automated discrepancy identification, safety/SAE data reconciliation, external vendor integration, and audit-ready database lock execution.

Study Startup eCRF Design Discrepancy Management SAE Reconciliation Database Lock

CDISC Standards & Legacy Migration

Complete CDISC transformation pipelines including raw-to-SDTM conversions, analysis-ready ADaM engineering, synchronized Define-XML (v2.0/v2.1) creation, reviewer guides (SDRG/ADRG), and Pinnacle 21 validation compliance.

SDTM Mapping ADaM Modeling Define-XML SDRG / ADRG Pinnacle 21 QC

Healthcare, Medical Device & Life Sciences Software

Tailored scientific software solutions, specialized digital applications, 3D anatomical and molecular visualizations, executive KPI dashboards, regulatory compliance modules, and automated laboratory workflows.

Custom Clinical Tools Medical Device Software 3D Visualizers BI & KPI Portals Workflow Automation

Plan Your Regulatory Data Delivery With Us

Share your clinical trial parameters, target indication, study size, and timeline. Our biostatisticians and SAS programming specialists will provide an initial scope, delivery model, and timeline.

Discuss Your Project