Statistical Programming

Full Programming

From raw data to SDTM, ADaM and TLFs — submission-ready.

We take full ownership of statistical programming for your study: mapping raw data to SDTM, deriving ADaM analysis datasets and producing every Table, Listing and Figure your clinical study report and regulatory submission need — validated, traceable and compliant with CDISC standards.

One team, the whole pipeline

  1. 1

    Raw data

    EDC, lab and external vendor data ingested and checked for quality and consistency.

  2. 2

    SDTM

    Data mapped to CDISC SDTM domains with annotated CRFs and full metadata.

  3. 3

    ADaM

    Analysis datasets derived per the SAP, traceable back to SDTM.

  4. 4

    TLFs

    Tables, listings and figures for the CSR, DMC meetings and publications.

  5. 5

    Submission

    define.xml, reviewer guides and conformance checks for FDA/EMA submissions.

SDTM and ADaM, done right

Our programmers map your raw data to SDTM and derive ADaM datasets that follow the current CDISC implementation guides. Every variable is documented and traceable, so reviewers can follow each result back to its source. Placeholder text — to be refined.

  • Annotated CRFs and SDTM mapping specifications
  • ADaM specifications aligned with your SAP
  • Independent double programming for validation
Raw data mapped to SDTM domains and derived into ADaM analysis datasets

Tables, Listings and Figures

We produce the complete set of TLFs for interim analyses, DMC meetings, the clinical study report and publications — efficacy, safety and PK outputs, delivered in R or SAS with consistent, reviewer-friendly formatting. Placeholder text — to be refined.

Example Tables, Listings and Figures: adverse event table, Kaplan–Meier figure and SAE listing

Ready for submission

Submission packages include SAS XPT datasets, define.xml, reviewer guides (cSDRG/ADRG) and resolved Pinnacle 21 conformance findings, ready for eCTD Module 5. Placeholder text — to be refined.

Submission-ready eCTD Module 5 data package with datasets, define.xml and reviewer guides
CDISC Gold Member 2026

Cogitars is a proud CDISC Gold Member

Supporting industry data standards for clinical research, ensuring our statistical deliverables meet the highest standards of interoperability and regulatory readiness.

Need submission-ready deliverables?

From raw data to TLFs, tell us about your study and timelines and we will outline how we can help.

Contact us