Statistical Programming with CDISC Standards

Summit Biostats has supported clinical trials of different phases and therapeutic areas, 

And the Summit Biostats programming teams consists of qualified statistical programmers who have experience in various types of trials.

 

Keeping our team up to date on all regulatory standards is very important in order to perform sound data analyses on appropriately set-up data sets.  Therefore, we perform regular training sessions on relevant topics such as CDISC (SDTM and ADaM), ICH, and other agency guidelines. Depending on the client’s preference, we can perform our services on either the customers IT systems or our own systems.

 

Summit Biostats programmers support our clients in the development and validation of outputs for clinical study reports and submission-ready deliverables. We offer a range of statistical programming services, such as:

  • Production of analysis data sets

  • Production of statistical analysis outputs (tables, listings, and figures)

  • CDISC (SDTM and ADaM)

  • Program validation

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110 Corcoran St. Durham NC 27701 

+1 843 367 2929

info@summit-biostats.com

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