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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



Data Management Plan

DMP defines the strategy and decisions made in relation to data management activities of the clinical study, including standards, processes, responsibilities and timelines. It also describes all data management deliverables and responsibilities of study personnel. DMP is an essential document to ensure quality, accuracy of data, compliance with GCP guidelines and reduce any associated risk. DMP is tailor made per study by Infoset according to the sponsor’s requirements or templates.