Small Pharma

Situation: HealthyYou is a small pharma company that is in the final stages of developing its best drug yet. It has done all its studies using DLPs, and so the data are consistent across all studies and are CDISC-compliant. The same programs are used to feed the data from each study into the integrated datasets, and the regulatory submissions group can run the integrated summaries.

Implementation: Because all the study reports were written using the same template, the writers know exactly where to find the information they need from each report. They are able to meet very aggressive timelines and their submission is accepted the first time..

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