Using SDTM data directly from BioStats to draft patient narratives has several tangible and intangible benefits, not the least of which is eliminating the need for patient profiles and giving time back to BioStats teams to do more constructive work. Both Medical Writers and BioStats see this as a welcome trend; it eliminates many of the mundane and tedious steps in writing both patient profiles and patient narratives and empowers them to focus on relevance and key message development - areas where human intelligence is key.
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