SDTM Data Conversion Services

SDTM Conversion

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.

Production of Define.xml and Define.pdf

Define.xml is the centerpiece of our services for producing the Biometrics components of eCTD submissions. Its ability to describe a set of data and documentation deliverables in a concise, standardized data format makes it a powerful tool for validating data, specifications and processes. PharmaStat’s DefineXML System generates conforming and reliable define.xml, checks the result against the data and against SDTM standard metadata, and diagnoses 80 categories of potential issues. We perform these services for both sponsor clients and their vendors. Our specifications and guidelines for define.xml content go beyond the CDISC rules, to assure both conforming and usable documentation.

SDTM, ADaM, and Define.xml Workshops

Every organization takes its own path to implement data standards. These days every new customer knows something about CDISC standards but many have an incomplete understanding. An orientation can be helpful for neophytes, and technical training is usually necessary for all. We provide workshops on SDTM, ADaM, and define.xml.

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