Looking for SDTM Migration Specialist

Despite CDISC became a widely accepted standard for electronic data submission with US-FDA soon no longer accepting non-CDISC submission and other regulatory agencies considering the same (e.g. the Japan PMDA initiated a pilot phase to assess CDISC submission requirements), many studies, not only the legacy ones, are still designed without having in mind the full CDISC-path (at least CDASH-SDTM from the eCRF design step). As a consequence migrating non-SDTM studies raw datasets to SDTM-compliant datasets is still absorbing a lot of sponsor resources. This paper discusses the implications/challenges of migrating studies to SDTM with practical and detailed examples from our experience. The goal is also to demonstrate that SDTM migration could be extremely challenging (and risky) especially with studies with complicated design either from the protocol or database design point of view (e.g. oncology studies) where in many circumstances SDTM migrated datasets represent an "extremederived" version of the original raw datasets.