Clinical Data Management

Clinical Data Management

Clinical Data Management (CDM) is a critical phase in clinical research and the integrity of clinical data is of paramount importance to a successful project. Jeevan ensures the integrity by strict adherence to established standard operating and review procedures at every stage of project, including complete large and complex clinical programs. Our data is delivered with quality assurance at every step and data management systems are in compliance with FDA 21 CFR Part 11 and industry guidelines for managing data.

Key Services

  • CRF or electronic CRF (eCRF) design and review, tracking and processing
  • Data management plan
  • Database design and testing
  • Double-data entry and Quality Control (QC) sampling for paper-based studies
  • Ongoing data review via edit checks and listings
  • Medical coding and review using MedDRA and WHO drug dictionaries
  • Query generation and processing
  • Electronic data integration and transfer
  • Serious adverse event (SAE) reconciliation
  • Customized status reports
  • Thorough multi-discipline QC review prior to database lock
  • Archival