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Abstract:
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Drug and medical device companies have been preparing for new electronic data submission requirements by investing heavily in tools and training sessions to prepare data and documentation that comply with CDISC standards. Navigating the data submission process for drug and devices that recently went into development and/or submission should be relatively clear since CDISC principles were most likely adopted early in the product's development life cycle. However, many products began development prior to CDISC forcing statisticians and statistical programmers to work with legacy data, the predecessors to SDTM, SEND and ADaM. The migration of legacy data and documentation to modern standards can be resource and time consuming. Working strategies will be discussed.
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