Clinical Statistical Programming

Overview

Our Clinical Statistical Programming services provide end-to-end support for the preparation of high-quality datasets, statistical outputs, and analysis deliverables for clinical studies. Our experienced programmers develop submission-ready SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TLFs), ensuring accuracy, efficiency, and compliance with regulatory requirements.
Phase I to IV Evidence
  • Creation of SDTM (Tabulation Module)
  • Mapping of raw data to SDTM datasets
  • Creation of SDTM compliant annotated CRFs (aCRF)
  • Validation of SDTM datasets
  • Creation of ADaM (Analysis Module)
  • Expert in SAS programs to produce tables, listings, and graphs (TLGs)
    • Ad hoc requests, clinical study reports and integrated summaries
  • Cross-functional Collaboration (to gather specifications for TLGs)
  • Validation of the analysis data sets and TLGs
  • Inputs in Case Report Form (CRF) development and database build
  • Execution of edit/logic checks
  • Functional Representation in the Client’s Study Management Team (SMT) meetings

Our Services

Dedicated Customer Teams & Agile Services

Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.