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Data management plan


CRF design, annotations and validation


EDC


Data Management Committee & Study Support Center


Queries generation, DCF submittion


PhV handling & Safety Reports


CDISC, SDTM and ODM standards


Statistical Analysis



CDISC, SDTM and ODM standards

We follow CDISC widely recognized standards for design, collection and exchange of clinical data and submission to clinical authorities. CDISC open data standards have been developed collaboratively by global volunteers to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting.