Data management drug development

SAS has always had and will maintain a central role in the data management, analysis, and reporting of clinical trial data. Because of the strong suite of SAS statistical procedures and the power of Base SAS programming, SAS remains a favorite of statisticians for the analysis of clinical trial data. Several companies have built their clinical trial data management and statistical analysis systems entirely with SAS software. More recently, SAS has offered SAS Drug Development as an industry solution that provides a comprehensive clinical trial analysis and reporting environment compliant with 21 CRF-Part 11. 

More trials, with greater numbers of subjects, necessitate utilisation of outside consultants and contract research organisations to manage sites, collect and verify data, assure protocol compliance plus adherence to GCP regulations. The number of outside companies who draw their livelihood from the growing size and complexity of the drug development process is itself an ominous portent. 

An impressive variety of LC/MS-based solutions, incorporating quantitative and qualitative process approaches, are now routinely applied to accelerate drug development. The results are significant and led to the successful development of innovative therapies and numerous novel drugs. The use of LC/MS with other technologies for sample preparation, analysis, and data management is now an inextricably linked element of drug development. 

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