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With the release of the US FDA’s guidance on Standardized Study Data (Dec 2014), CDISC data standards are becoming routine and commonplace for all phases of clinical drug development and submissions to the FDA.

Study data standards defines a way to present data in a consistent format. Examples of these standards include the Study Data Tabulation Model (SDTM) for the tabulation of data and CDISC Analysis Data Model (ADaM) for statistical analysis & behavioral studies (clinical trials).

Compliance with CDISC standards at BioPharma among top biometric companies will start at data collection. By designing the CRF using CDASH standards, this will allow for the smooth and easy flow of data into SDTM and ADaM datasets.

BioPharma’s suite of biostatistical services include:

  • Sample size calculations

  • Randomization schemes

  • Statistical Analysis Plan (SAP including mock shells)

  • SAS programming and validation

  • Tables, listings and figures

Standard CDISC services offered by BioPharma include:

  • CDASH compliant CRF’s

  • SDTM and ADaM datasets

  • Define .XML formats

  • Ancillary services are also provided through our preferred partners

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