• Study Datasets development – Ex. SDTM.
  • Analysis Datasets Development – Ex. ADaM.
  • Legacy Data convesion as per Regulatory Norms ( Ex. SDTM Mapping)
  • Development of Regulatory submission packages Ex: Reviewer’s guide,Define.xml, etc…
  • Developing TLFs (Tables, Listings and Figures)
  • Study Analysis and Reporting
  • Publications
  • eCTD Submission & post Regulatory Queries Support
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  • Annotated table shells
  • Independent Validation
  • Code reviews
  • Centralized status tracking
  • Strict adherence to SOPs
  • Automates the standardized QA/ QC processes

Our Statistical Programming Includes

Our proficient team of Statistical Programmers work closely with our experienced biostatisticians in the creation and validation of best programming framework with set of well-defined macros and best practices, which is flexible to adapt to customer’s requirements in clinical studies from pre-clinical to post market analysis. This framework combined with our Quality processes defines the “Programming Platform”.

Biostats IT Solutions programmers have built a reputation of excellence by producing quality deliverables, as we have years of SAS®, R, WinNONLin, Data Visualization Programming skills, combined with in-depth knowledge of specific clinical subject matter.

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