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Validating clinical trial data reporting with sas

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SAS is currently the dominant software tool for data preparation and statistical analysis in this domain.There is a misconception that SAS is the preferred software of the FDA, the regulatory agency that oversees clinical trials, but in fact the FDA does not endorse or require use of any specific software.For more information on the Bio Pharma Institute’s training programs, or to suggest a course, please complete the form located below.

The product relies on SAS Data Integration to deliver centralized metadata management using the SAS Metadata Server.

Classes are conducted by Certified SAS Clinical Working Professionals with 100 % Quality Assurance.

With an experienced Certified practitioner who will teach you the essentials you need to know to kick-start your career on SAS Clinical .

To that end, the R Foundation has created the document R: Regulatory Compliance and Validation Issues.

Described as "a guidance document for the use of R in regulated clinical trial environments", the purpose of this document is to demonstrate that R, when used in a qualified fashion, can support the various regulatory requirements for validated systems, most notably 21 CFR Part 11 and the relevant "good practice" documents (Gx P) and industry guidance documents.