Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Biostatistics & Data Management CRO India

Auriga Research delivers the quantitative backbone for clinical trials and regulatory submissions — Statistical Analysis Plans built on the ICH E9(R1) estimand framework, CDISC SDTM v3.3 and ADaM v2.1 datasets, and submission-ready tables, listings, and figures that satisfy CDSCO, FDA, EMA, Health Canada, TGA, and other ICH M4 member regulators.

Statistical computing in both SAS and R — FDA 2023 guidance accepts both platforms for regulatory submissions. We deliver SAS-format extracts for all CDISC datasets and use R for Bayesian methods, advanced visualisations, and specialised analyses. Sample size and power calculations use SAS, R, nQuery, and PASS following ICH E9 / E9(R1) principles.

Biostatistics works directly inside Auriga's integrated platform — Clinevo EDC for data capture, OneClinicalTrials CTMS for project state, and OneQMS for deviations and CAPA. No data extraction, transformation, or handoff between vendors. The EDC, CTMS, and statistical output share the same data model, reducing query cycles and protecting timeline. All operations are 21 CFR Part 11, ANNEX 11, GxP, and GDPR compliant under ICH E6(R3) GCP.

Request a Biostatistics Proposal Call +91-7428116100

ICH E9(R1) Estimand Framework

Every SAP we author defines the treatment effect of interest, the strategy for each intercurrent event, and the corresponding estimator — the structure FDA and EMA reviewers expect in new submissions.

Treatment Policy

Effect regardless of intercurrent events

Hypothetical

Effect if intercurrent event had not occurred

Composite

Intercurrent event part of endpoint definition

While-on-treatment

Effect measured while on assigned treatment

Principal Stratum

Effect in a defined sub-population

Required by FDA, EMA, Health Canada, TGA, and other ICH M4 member regulators.

Why Auriga for Biostatistics

Our biostatisticians work within the same integrated platform as clinical operations, site management, and pharmacovigilance. When a protocol amendment changes the statistical design, the impact is reflected across CTMS, EDC, and SAP without inter-system reconciliation. One platform, one QMS, one team. Deviations flagged during a trial automatically link to CAPA records in OneQMS — closing a feedback loop most CROs leave open.

Biostatistics & Data Management Services

Statistical Analysis Plans (ICH E9 / E9(R1))

SAPs built on the estimand framework — defining treatment effect of interest, intercurrent event strategy, estimator, and sensitivity analyses. Multiplicity adjustments and adaptive design considerations included.

CDISC Data Standards — SDTM v3.3 / ADaM v2.1

SDTM v3.3 tabulation and ADaM v2.1 analysis datasets with controlled terminology mapping, Pinnacle 21 Enterprise validation, define.xml, and reviewer guides for FDA and EMA electronic submission.

Sample Size & Power — SAS, R, nQuery, PASS

Sample size estimation accounting for dropout, stratification, interim analyses, and adaptive design elements. Power calculations supported in SAS, R, nQuery, and PASS per ICH E9(R1).

Randomisation & Blinding

Computer-generated randomisation schedules (simple, block, stratified, adaptive), IWRS/IXRS integration via Clinevo EDC, and emergency unblinding procedures with full audit trail.

Interim & Final Analyses

Pre-planned interim analyses with alpha-spending functions (O'Brien-Fleming, Lan-DeMets), independent DMC/DSMB support, and definitive final analyses per the locked SAP.

Clinical Data Management — Clinevo EDC

eCRF design and validation in our in-house Clinevo EDC, edit-check programming, query management, MedDRA / WHO-DD coding, SAE reconciliation, and database lock procedures under GCDMP.

TLF Programming — SAS and R

Tables, listings, and figures generated in SAS and R with double-programming validation. FDA 2023 guidance accepts R alongside SAS for regulatory submissions. ICH E3-compliant CSR outputs.

Regulatory Submission Support

Statistical sections for CTD Module 2.7 and Module 5, ADaM datasets for electronic submission, define.xml, reviewer guides, and statistical responses to CDSCO, FDA, and EMA queries.

Related Services

CRO Services Overview Full CRO capabilities Clinical Trials Phase II-IV & bioanalytical BA/BE Monitoring Independent BE monitoring & PK Pharmacovigilance Drug safety monitoring Medical Writing Regulatory submissions Site Management Clinical trial site support Pharmaceutical Testing Analytical & stability testing

Frequently Asked Questions

Does Auriga implement the ICH E9(R1) estimand framework?
Yes. Every Statistical Analysis Plan we author defines the treatment effect of interest, specifies the strategy for each intercurrent event (treatment policy, hypothetical, composite, while-on-treatment, or principal stratum), and the corresponding estimator and sensitivity analyses. ICH E9(R1) is now required by FDA, EMA, Health Canada, TGA, and other ICH M4 member regulators for new submissions.
Which CDISC versions does Auriga use?
SDTM v3.3 for submission tabulation datasets and ADaM v2.1 for analysis datasets — formatted for FDA and EMA electronic submission. CDISC validation runs on Pinnacle 21 Enterprise with controlled-terminology mapping (CT), define.xml, and reviewer guides delivered as part of every submission package.
What statistical software does Auriga use?
SAS (Base SAS, SAS/STAT, SAS/GRAPH) and R — FDA 2023 guidance accepts both platforms for regulatory submissions. We deliver SAS-format extracts for all CDISC datasets and use R for Bayesian methods, advanced visualisations, and specialised analyses. nQuery and PASS are used for power and sample-size calculations.
How does Clinevo EDC integration help sponsors?
Biostatistics at Auriga works directly from our in-house Clinevo EDC system — no data extraction, transformation, or handoff between vendors. The EDC, CTMS, and statistical output share the same data model, reducing query cycles and protecting timeline. Protocol amendments that change the statistical design are reflected across CTMS, EDC, and SAP without inter-system reconciliation.
How is sample size determined for clinical trials?
Sample size estimation depends on study design, primary endpoint, expected effect size, variability, significance level (alpha = 0.05 typical), and desired power (80–90% typical). For PK and BA/BE monitoring engagements, sample size is based on the intra-subject coefficient of variation of the pharmacokinetic parameters. Our biostatisticians use SAS, R, nQuery, and PASS following ICH E9 / E9(R1) statistical principles.
Can Auriga support FDA, EMA, and CDSCO submissions?
Yes. We prepare statistical sections for CTD Module 2.7 (Clinical Summary) and Module 5 (Clinical Study Reports), ADaM analysis datasets, define.xml, reviewer guides, and all tables/listings/figures for regulatory review. Our team provides statistical consultation during pre-submission meetings and authors statistical responses to regulatory queries.

Get Your Biostatistics Proposal

ICH E9(R1) estimand-based SAPs, CDISC SDTM v3.3 / ADaM v2.1 datasets, SAS and R statistical analysis, and Clinevo EDC integration — for CDSCO, FDA, and EMA submissions.

+91-7428116100 Request a Biostatistics Proposal

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