Life Sciences Data Expertise

Clinical Data Done Right

Clinical trials generate vast, complex datasets that must meet stringent regulatory standards for FDA, EMA, and ICH submissions. Hetasalvation's clinical SAS programmers have deep domain knowledge of CDISC standards, regulatory requirements, and clinical data workflows — ensuring your data is submission-ready.

From SDTM mapping to ADaM dataset creation and TLF development, we support the full statistical programming lifecycle with quality and precision.

Discuss Your Clinical Project →

SAS Services

Clinical SAS Capabilities

📊

SDTM Dataset Creation

CDISC SDTM mapping and dataset creation that complies with FDA and EMA submission requirements — structured, annotated, and validation-ready.

SDTM mapping specifications
Dataset creation (all domains)
Annotated CRF development
Define.xml generation
Pinnacle 21 validation

📈

ADaM Dataset Development

CDISC ADaM analysis datasets that support statistical analysis and efficacy/safety reporting — fully traceable to source SDTM data.

ADSL, ADAE, ADLB, ADTTE datasets
Derived variable programming
Analysis population flags
ADaM traceability documentation
Reviewer's Guide preparation

📋

TLF Generation

Tables, listings, and figures for CSR and regulatory submission — programmed to specifications with peer review and QC documentation.

Safety summary tables
Efficacy analysis tables
Adverse event listings
Kaplan-Meier survival curves
Forest plot generation

✅

Statistical Programming QC

Independent QC programming and double-programming to ensure outputs are accurate, reproducible, and meet ICH E3 quality standards.

Double programming / independent QC
Output comparison & reconciliation
Review of statistical analysis plans
Validation of derived datasets
QC documentation & sign-off

📁

Regulatory Submission Support

End-to-end support for NDA/BLA/MAA submissions — SEND, SDTM, ADaM packages prepared and validated per FDA eCTD requirements.

eCTD submission package preparation
SEND dataset creation (non-clinical)
Integrated summary preparation
Agency query response support
Submission timeline management

🔬

Clinical Data Management

Data collection, cleaning, and coding services that feed clean, complete data into the statistical programming pipeline.

EDC system setup & testing
Data validation edit check programming
MedDRA / WHO Drug coding
Data reconciliation (lab, ECG, PK)
Database lock preparation

Clinical SAS