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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

CRF design, annotations and validation

We offer professional CRF design according to study protocol and endpoints and also data field optimization for EDC which enables tracing and monitoring of CRFs, sites and patients. Also CRF annotation is applied in both for electronic and paper based trials. System validation is processed with specialized methodology compliant with 21 CRF part 11 and GCP.