Whitepaper: Leveraging a Compliant Data Repository to Significantly Improve Biostatistics Workflow


Are you utilizing a 21 CFR Part 11 compliant repository for your R, SAS, Python and other clinical data?

A statistical analysis includes input datasets from various sources, mature reusable code, bespoke programming, intermediate results, and final output. It is the collection of these various assets that represent an analysis that is attributable, traceable, and reproducible. For this reason, it is important to version entire statistical analyses, and not just versions of files. Furthermore, because data is frequently updated, tracking relationships between input datasets and statistical analyses is critical to ensure analyses are current. Download this white paper to learn how Certara’s Integral data repository:

  • Improves your biostatistics workflow by providing analyses that are traceable, reproducible, and secure
  • Efficiently organizes, manages, and tracks your biostatistical data in a cloud-based and validated 21 CFR Part 11-compliant environment
  • Tracks relationships between input datasets and statistical analyses to ensure your analyses are always current

Integral is designed to be a 21 CFR Part 11 compliance bolt-on solution to your existing statistical computing environment. This means Integral is compatible with your cloud-based and on-premise computing environments and is agnostic to the analytical software being used at your organization (SAS, R, Python, etc.). As a result, implementation of Integral can take as little as 4 weeks!

Back to top