• Define.xml is a file required as part of drug submission to FDA. It describes the structure and contents of the data collected during the clinical trial. Over the past 12 years of our experience, we have generated define.xml files for studies pertaining to various therapeutic areas. The main challenge faced during this process has been […]

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  • Clinical trial study designs can range from open label to blinded. In open label studies, subjects and investigators know which product, each subject is receiving. Whereas, in blinded studies, the subject, investigator, or anyone assessing the outcome is unaware of the treatment assignment(s) to reduce potential for bias. To support standardization of various collection methods […]

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  • The defined variables of the SDTM general observation classes could restrict the ability of sponsors to represent all the data they wish to submit. Collected data that may not entirely fit includes relationships between records within a domain, records in separate domains, and sponsor-defined variables. Related Records (RELREC) is a special-purpose dataset used to describe […]

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  • For SDTM mapping, Protocol and CRF will serve as the initial supporting document, Database schema along with sample data if available will aid in better understanding of the database structure which will give clarity in mapping and defining specification. Annotated CRF (aCRF) will be created against the blank CRF which will map the fields in […]

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