PharmaStat does a lot of SDTM conversions. Our proprietary conversion systems use a high degree of automation to create SDTM data from metadata mappings. Their internal checks assure that the specifications are complete and precise. SDTM conversions are getting more complicated every day, but our expertise and systems produce an efficient and traceable process.
PharmaStat consultants are also industry leaders in SDTM documentation for eCTD submissions. We helped develop both the Study Data Reviewer’s Guide and Analysis Data Reviewer’s Guide documents referenced on the FDA website.