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CROs: Stuck in a Rut?

The implementation of Clinical Data Interchange Standards Consortium (CDISC) standards is proceeding at various rates across the pharmaceutical industry, and there seem to be nearly as many approaches as there are organisations. This article will discuss one of the practical aspects of implementation, namely the mapping of source data structures to study data tabulation model (SDTM) and analysis dataset model (ADaM) standards, and examine why some contract research organisations (CROs) have been slow to invest in technical solutions to expedite this process.

According to a study conducted by CDISC, Tufts and Gartner, the lack of standards implementation is costing, on average, an estimated $9 million per trial in direct costs, and reducing the potential to shorten the time taken for clinical trials by 60 per cent (1). Of most interest to CROs is the second figure; a great deal of the direct costs to a CRO’s bottom line is taken up with the expensive process of converting source data to CDISC SDTM and ADaM standards.

This process generally involves a complex restructuring of data in a way that must be transparent and validated; a reasonably sized Phase III study can take around six months to convert if done through the traditional handcranked code method. This would be a validated process, but the provenance of each item of data is not immediately clear, and clarity around derived items is something the FDA is particularly keen to ensure.


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Dave Smith is a Pharmaceutical Solutions Architect at SAS UK. He works across R&D, manufacturing, sales and marketing, exclusively supporting pharmaceutical projects for the SAS UK Healthcare and Life Science team. His responsibilities include designing SAS software solutions to meet the critical business needs of life sciences organisations. Dave joined SAS from the pharmaceutical industry over 10 years ago. Previously he had spent five years in academia specialising in epidemiological research, followed by five years at Sandoz/Novartis and Parexel. His current interests include support of CDISC standards, pharmacovigilance and the ways in which SAS can support these activities.
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