Mission Statement
Our mission is to provide first class clinical SAS validation for the pharmaceutical and biotechnology industries. Whether it is to validate SAS code, or the data itself, we are committed to providing the client with the highest possible quality of service. By providing an independent unbiased validation, we can help to ensure that the output is correct before an organization submits its work to the FDA.
We are your clinical SAS validation specialists! We are not a big CRO that tries to do everything. We only do clinical SAS validation. Furthermore, outsourcing validation has the following advantages:
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Validation is unbiased since we are not stakeholders.
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We can dramatically reduce your workload so you can stay on schedule.
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Since we are specialists, you can be assured that validation is not treated as an afterthought, but it is treated as a high priority item.
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Validation has now become a priority with the FDA. It is not sufficient to document that validation has been done; the FDA wants to know the process behind the validation. We document our process in detail and make that available to the FDA when submitting your NDA or BLA.
Our validation services include the following:
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Tables, Listings and Graphs in any phase of a clinical trial.
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SAS macros (single stand-alone macros, or a complete macro library)
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Edit Checks (Data validation)
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Analysis Data Sets
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CRTs
In addition, we can provide feedback for your Statistical Analysis Plan and Case Report Forms.
Why should you have confidence in our organization? Please examine the Bio of our founder.