Statistical Programming

Statistical Programming

As a CDISC Registered Solution Provider since 2009, we provide diversified SAS programming services tailored to customer needs. We have vast experience with many therapeutic areas and indication across different study phases and constantly keep up with current guidance and developments as they pertain to data standards and regulatory demands.

The clinical programming division provides Data Management with programming support, for example the creation of data cleaning listings, handling vendor data imports and data transfers to Biostatistics or the Sponsor.

The statistical programming division specialize in the creation of standardized datasets (SDTM or other standards), analysis datasets (ADaM or other standards) and analysis outputs (Tables, Figures and Listings) including Integrated Summaries to support our clients’ submissions. We have specialized experience in integrating legacy studies with recent studies to establish a unified and cohesive package.

Together with our statistical and medical writing team we can assist in planning the client’s data strategy to make sure the submission won’t be held by unexpected demands from regulatory entities.

Statistical Programming Services

  • CDISC – SDTM, ADaM, SEND (pre-clinical), SDTM-MD (Medical Devices)
  • Metadata – define.xml, SDRG and ADRG
  • Legacy studies support –
    • Gap analysis according to the latest regulation
    • Prepare legacy package for submission
    • Data conversion to CDISC standards
  • Statistical analysis of clinical data
    • As part of INDs, IDEs, NDAs, 510Ks, PMAs, ANDAs and BLAs
    • Study Interim analysis
    • Custom analysis per customer/regulatory agencies requirements
    • Meta-analyses of multiple sources
  • Tables, listings and figures (TLFs)
  • Data integration and analysis for safety and efficacy summaries (e.g., ISS/ISE)
  • Periodical and safety committees reports (e.g. DSUR, DMC)

Registered Solution Provider

Over 10 years of CDISC experience

FDA Submissions

20+ data submissions to date

Throughout the Trial

Supporting your ongoing trial needs