System and method for managing a workflow for biomedical development
Abstract:
A method and system for managing a workflow for producing a biostatistical analysis (BA) of biomedical data. The data originates from a milestone (or snapshot) of a clinical study performed by, or on behalf of a life science company that performs the BA. The data may be from a blinded or un-blinded clinical study. SAS programs are used for the BA. An audit trail is produced to track changes to any of the data or programs used during the course of the workflow. The programs and data used to produce reported results from the BA are stored in electronic format for sending to a regulatory agency.
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