SAS to R migration: Strategic budgeting and regulatory considerations

Organizations migrating regulated statistical analysis from SAS to R should focus their budgets on planning rather than programming. While the R language itself is cost-effective, the primary costs and risks stem from organizational processes and documentation.

Regulatory bodies like the FDA do not mandate specific software, provided that the version, build, and testing are thoroughly documented in submissions. Unlike SAS, where much of the validation evidence is included with the license, R requires the organization to produce its own evidence of reliability.

The R Consortium’s R Submissions Working Group has established public precedent by successfully taking R-based tables, figures, and datasets through FDA review in various pilot projects. Additionally, much of the clinical tooling used by SAS teams now has maintained R equivalents developed through collaborative industry efforts.