Data Management

Data management is a disciplined process that requires well-trained, detail-oriented staff who provide continuous monitoring and audit tracking of all submitted data. Compliance is also required with 21 CFR Part 11 and related guidance from

  • Food and Drug Administration (FDA)
  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals (ICH)

Westat's data management staff provide extensive systems support capabilities. Our team consists of clinical data managers, data research associates, database developers, data entry specialists, medical coders, and database administrators. In conjunction with other applicable functional areas, we develop data management and data quality plans during project start-up. These plans outline detailed procedures that ensure accurate and consistent data collection, management, auditing, cleaning, and documentation throughout the life of a trial.

Services

  • Case report form (CRF) development through FrameMaker® application (other design tools also available upon request)
  • Oracle Clinical™ database design and validation
  • Computerized patient eligibility screening and randomization
  • Data collection (electronic [web and batch data load], paper, computer-assisted telephone interviews)
  • Extensive training program for Oracle Clinical’s™ web-based, electronic data capture (EDC) application
  • Medical coding using MedDRA, WHO-DD, plus any study-specific dictionaries
  • Data cleaning using programmed edit checks and manual reviews
  • Data reconciliation between different data collection systems
  • Electronic imaging, tracking, and storage of hard-copy data submissions
  • Data management reports