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Data Standardization and Warehousing

The testing phase of Clinical Development takes years to complete and can result in clinical trial data being collected from up to 30 or 40 clinical trials. The preparation of a submission to Regulatory Agencies requires the aggregation of these clinical data into a consolidated and standardized structure.

A data warehouse is a data repository that allows for data from multiple data sources: multiple CROs, clinical laboratories, and other vendors, to be housed and subsequently standardized. Data, regardless of file type, is imported and converted into a common format (CDISC SDTM, ADaM, or sponsor defined format). A first step in this process is the development of a standardization map, which documents the relationship of the original data to the new standardized format and is based on the electronic annotated CRF for each individual clinical trial. Following the completion of the standardization map, the data are subjected to programmatic standardization. Once standardized, the data are available in a submission-ready format as well as being available for aggregate reporting. Data from multiple studies may be reviewed and queried which is invaluable when reviewing data for a given compound.

Attachments:
Data Warehousing Case Study.

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Data Management Rescues

A large number of clinical trials are outsourced to Contract Research Organizations (CROs) each year. While the majority of these trials are successfully implemented and study results are delivered on-time and on-budget, situations arise when the study is not adequately managed by the vendor and the study must be “rescued”. The scope and type of study management deficiency needs to be assessed by the Sponsor to determine the type of remediation required. Rescue support may be as simple as adding third-party function experts to the Sponsor project team to aid in the management and oversight of the CRO, or as complex as selecting a new CRO to assume all responsibility for the study.

Attachments:
Data Management Rescues Whitepaper