Data Management

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

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

Westat's data management staff includes clinical data managers, data research associates, database developers, data entry specialists, medical coders, and extensive systems support capabilities. Our comprehensive team develops data management and data quality plans during project start-up. These procedures ensure accurate and consistent data collection, management, auditing, cleaning, and documentation.

Services

Case report form (CRF) development through FrameMaker® application
Oracle Clinical^™ database design and validation
Computerized patient eligibility screening and randomization
Data collection (electronic [web and batch data load], paper, and 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
Electronic tracking and storage of CRFs and other data submissions
Data management reports