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.
SEND datasets have become an integral part of the review, analysis, and interpretation of nonclinical toxicology studies, and this will trend will only continue to grow. The SEND dataset creation process is challenging and often requires a combination of data integration and manual effort, making quality control a critical step to ensuring that these dataset packages are fit for use.
On April 18, Senior Product Management Director Peggy Zorn delivered an information-packed presentation on best practices and recommendations for SEND dataset review and visualizations. Check out the recap!