Clinical data standardization and integration


Our data integration and standardization experts have knowledge and experience in CDISC principles and submission requirements. Our expertise includes:


Preparation of legacy data from various sources for submissions
Data pooling for integrated analyses and data mining
Creation of submission deliverables compliant to FDA requirements
Mapping of clinical database to CDISC SDTM
SDTM annotated blank CRF
Generation of ADaM data based on SDTM
Consistency checks between SDTM and ADaM
Compliance checks with open CDISC validator
Compliance with sponsor standard (e.g. controlled terminology)
Creation of define.xml


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