Clinical Data Management

Our expert data management services are designed to make every part of the clinical research data management process more efficient and more predictable. Our clinical data managers know how to make EDC technology work for your trial to ensure you get the best possible results. We minimize the risks associated with EDC and clinical data management, and help you capture clean and accurate clinical research data, while meeting key deadlines and budget requirements. So you’ll spend less time training for each project and more time running efficient trials. Although our clinical data specialists manage all the data, you stay in complete control — with continuous access to your data and total transparency to the study progress.

Benefits

  • An experienced team helps you manage your studies and maximize the value of eClinical technologies by using trained staff in data management and the BioClinica software
  • Our data managers are experienced in a wide range of therapeutic areas, adding substantial value to the electronic management of the study.
  • Eliminate contract hassles and vendor finger-pointing by gaining more services through one contract— with one point of contact.
  • Begin your clinical study faster and see accurate, clean results sooner.
  • Have near real-time access to clean clinical data.
  • Spend less time managing vendors so you can focus on trial analysis and insights.

Essential data management capabilities include:

  • Data management plans and guidelines
  • Quality Agreement Development
  • Formal data quality management
  • Project management
  • Electronic Data Capture and IVR
  • Database design
  • Full data integration (eCRF, IVR, laboratories, images and other instrumentation)
  • Data validation and review
    - Data validation checks
    - Logic checks
    - Programmatic queries
  • eCRF design
  • eCRF generation and initial edit check specifications
  • eCRF completion guidelines (if requested)
  • Non-logic consistency checks (manual/clinical data review and query generation)
  • Manual query generation and resolution
  • Medical term coding (MedDRA, WHODRUG, COSTART, ICD-9, client dictionaries)
    - Coding guidelines
    - Manual coding
    - Review and approval of coding
    - Dictionaries, coding and exception reports back to the Sponsor
  • Data exports — at your discretion
  • Final quality checks of study data
  • CDISC compliant SAS® datasets

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