ICH E9 Compliant · CDISC Standards

Biostatistics & Clinical Data Management India

Auriga Research's biostatistics and clinical data management division provides the quantitative backbone for clinical trials and regulatory submissions. Our team of qualified biostatisticians and SAS programmers delivers statistical analysis plans, CDISC-compliant datasets, interim and final analyses, and submission-ready tables, listings, and figures that satisfy CDSCO, FDA, and EMA requirements.

Clinical data management at Auriga Research follows GCDMP (Good Clinical Data Management Practices) guidelines. We design and validate electronic case report forms (eCRFs), implement edit checks and data validation rules, perform medical coding using MedDRA and WHO-DD, and produce clean, locked databases ready for statistical analysis. All data management activities maintain 21 CFR Part 11 compliance with full audit trails.

Our biostatistics capabilities extend from study design consultation and sample size calculation through randomisation, blinding, interim monitoring, final analysis, and regulatory query responses. We work across all phases of clinical development — from small bioequivalence studies to large multi-centre Phase III trials — with consistent statistical rigour per ICH E9 principles.

Request a Biostatistics Proposal Call +91-7428116100

Biostatistics & Data Management Services

Statistical Analysis Plans

Detailed SAPs defining primary and secondary endpoints, analysis populations, statistical methods, multiplicity adjustments, and sensitivity analyses per ICH E9.

CDISC Data Standards

SDTM and ADaM dataset creation with controlled terminology mapping, Pinnacle 21 validation, define.xml generation, and reviewer guides for regulatory submissions.

Sample Size & Power Calculations

Rigorous sample size estimation using validated software, accounting for dropout rates, stratification, interim analyses, and adaptive design elements.

Randomisation & Blinding

Computer-generated randomisation schedules (simple, block, stratified, adaptive), IWRS/IXRS integration, and emergency unblinding procedures.

Interim & Final Analyses

Pre-planned interim analyses with alpha spending functions (O'Brien-Fleming, Lan-DeMets), data monitoring committee support, and definitive final analyses.

Clinical Data Management

eCRF design and validation, edit check programming, query management, medical coding (MedDRA, WHO-DD), SAE reconciliation, and database lock procedures.

TLF Programming

Tables, listings, and figures generated in SAS with validated programs, meeting ICH E3 clinical study report requirements and regulatory submission formats.

Regulatory Submission Support

Statistical sections for CTD Module 2.7 and Module 5, analysis datasets for electronic submissions, and statistical responses to regulatory queries.

Related Services

CRO Services Overview Full CRO capabilities Clinical Trials Phase I-III & bioanalytical Pharmacovigilance Drug safety monitoring Medical Writing Regulatory submissions Site Management Clinical trial site support Pharmaceutical Testing Analytical & stability testing

Frequently Asked Questions

What biostatistics services does Auriga Research provide?

Auriga Research provides comprehensive biostatistics services including sample size calculation, randomisation schedule generation, statistical analysis plan (SAP) development, interim and final statistical analyses, CDISC-compliant data management (SDTM and ADaM datasets), data validation and cleaning, table/listing/figure (TLF) generation, and statistical input for clinical study reports per ICH E3 and ICH E9 guidelines.

What is CDISC and why does it matter for clinical data?

CDISC (Clinical Data Interchange Standards Consortium) defines standard data formats for clinical research. SDTM (Study Data Tabulation Model) standardises how clinical data is organised, and ADaM (Analysis Data Model) standardises analysis-ready datasets. CDSCO, FDA, and other regulators increasingly require CDISC-compliant data submissions. Auriga Research builds SDTM and ADaM datasets with standardised controlled terminology and validation using Pinnacle 21 (OpenCDISC).

How is sample size determined for clinical trials?

Sample size calculation depends on the study design, primary endpoint, expected effect size, variability, significance level (typically alpha = 0.05), and desired statistical power (typically 80% or 90%). For bioequivalence studies, sample size is based on the intra-subject coefficient of variation of the pharmacokinetic parameters. Our biostatisticians use validated software (SAS, R, nQuery) and follow ICH E9 statistical principles to ensure studies are adequately powered.

What statistical software does your team use?

Our biostatistics team uses SAS (Base SAS, SAS/STAT, SAS/GRAPH) as the primary statistical platform, consistent with regulatory expectations. We also use R for specialised analyses, graphical output, and Bayesian methods. Data management uses validated EDC systems with built-in edit checks. CDISC validation is performed using Pinnacle 21 Enterprise. All statistical programming is version-controlled and follows CDISC Submission Data Standards.

Can you provide biostatistics support for regulatory submissions?

Yes. Our biostatisticians prepare statistical sections for CDSCO, FDA, and EMA regulatory submissions including Module 2.7 (Clinical Summary) and Module 5 (Clinical Study Reports) of the CTD format. We generate analysis datasets (ADaM), define files, reviewer guides, and all tables, listings, and figures required for regulatory review. We also provide statistical consultation during pre-submission meetings and respond to regulatory queries on statistical methodology.

Get Your Biostatistics Proposal

CDISC-compliant data management, SAS programming, and ICH E9 statistical analysis for clinical trials and regulatory submissions.

+91-7428116100 Request a Biostatistics Proposal