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Data
management is a disciplined process that requires well-trained,
detail-oriented staff, continuous monitoring, audit tracking,
and compliance with 21 CFR Part 11 and related FDA/ICH guidances.
Westat's data management staff includes clinical data quality
managers, systems analysts, database developers, data entry
specialists, and extensive systems support capabilities. Our
comprehensive team develops data management and data quality
management plans during project start-up to ensure accurate
and consistent data collection, management, auditing, cleaning,
and documentation. |
Services:
- Oracle
Clinical™ database design and validation
- Data
management, audit, and documentation
- Computerized
patient eligibility screening and randomization
- Data
collection-electronic (web and batch data load), paper,
and computer-assisted telephone interviews
- Medical
coding by MedDRA, COSTART, and WHO-DD
- Query/data discrepancy resolution
- Database
QA and QC
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