Vita Data Sciences Case Study: Integrated Summary of Safety (ISS) Analysis Using Pooled SDTM Datasets
Background The sponsor is a multinational biopharmacautical company focusing in the treatment of rare diseases. Vita Data Sciences was contracted to pool data from eight studies for ISS analysis. The Challenge The main challenge that the sponsor was facing was that many of the studies…
Niche Provider for Successful NDA Submissions
This case study outlines a project where VDS, as a niche provider, worked with a Sponsor towards their final NDA submission packet, even though the Sponsor had outsourced these services to a global full-service CRO. To download this case study, please submit the form below…
Vita Data Sciences, a division of Softworld Inc.
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