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Data management plan

CRF design, annotations and validation


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.