Data Standards Management and Advisory

Life Sciences companies are required by regulatory agencies to achieve data transparency and traceability. HighPoint solutions helps R&D data owners in development of organizational standards, clinical operations metrics, migration and mapping of existing CDISC data standards ( XML, SDTM, SEND, ODM etc.) production of standards, standards education and Standards Governance Model i.e. stewardship, issue tracking and resolution management to meet the regulatory and quality needs.

R&D organizations are faced with the challenges in handling large volumes of data, its complexity, the speed of accumulating data and data standardization through the R&D life cycle. A survey of Life Sciences recently estimated that as much as 80% of clinical data collected is left in older or legacy standards because companies typically only complete re-consolidation of exactly the new data that is required for compliance. HighPoint Solutions assists you in navigating through challenges encountered during data acquisition, aggregation, distribution, and analysis. Our team of experts provides guidance on an overall R&D Data Strategy covering usability, standards, data governance, quality, and stewardship.

 

How can HighPoint Solutions help you?

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