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Clinical Data Management

Our Clinical Data Management team provides all data management services from protocol development through database lock. Our expertise includes a wide range of therapeutic areas with multiple clinical data management systems and complex workflows that require integrating data from a multitude of sources. Our team designs, builds, and manages electronic data capture systems for studies and registries. We provide comprehensive data validation and monitor for data issues.

We offer the following services:

  • Design of protocols, data collection forms, data collection processes
  • Comprehensive database programming
  • Data validation checks
  • Data query issuing and resolution
  • Data management plans (DMPs)
  • Full data integration (eCRFs, images, laboratory data, other instrumentation)
  • Study-specific change control process management and documentation
  • EDC and data management system training
  • SAE reconciliation
  • Medical term coding (e.g., adverse events, medications)