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Our experienced Clinical Data Management team provides all data management services for the Data Coordinating Center 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. All of our lead Clinical Data Managers are Certified MedDRA Coders which ensures high-quality coding of adverse events.

Specific Clinical Data Management activities include:

  • Contribute to the design of protocols, forms, and data collection process
  • Provide comprehensive database programming
  • Create data validation checks
  • Issue and resolve data queries
  • Create and maintain data management plans
  • Full data integration (eCRF, images, laboratories, other instrumentation)
  • Manage and document study specific change control process
  • Provide training on EDC and other data management systems
  • SAE reconciliation
  • Medical term coding (i.e. adverse events, medications)