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• Data Set Specifications

A key component in the data set process, the specifications are no longer just a tool to use for programming.  With upfront considerations and foresight, the data set specifications can be used for so much more; from programming through development of your define.xml and Reviewer’s Guide. Let DataRich Consulting assist you in creating or reviewing your data set specifications or processes to maximize their utilization across all areas.

• CDISC

Now a requirement for FDA and PMDA submissions, ensuring that the submission package is compliant is key.  Being well versed in the standards and able to read and interpret the outputs from validation tools, as well as perform manual validation and develop/review the Reviewer’s Guide, DataRich Consulting can help you with the preparation of your submission package.

• Programming

Many times, novel approach is needed as opposed to a basic approach to programming / performing quality control (QC) for data sets, tables, listings, and figures.  Keeping up to date on new features and ideas in SAS can help to facilitate efficient programming. With extensive experience in working with a variety of clients, as well as providing training at regional conferences, DataRich Consulting can help you with your programming concerns.