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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



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.