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PPCE uses Clinfoware’s EDC solution to ensure fast, reliable and cost effective results for our customers.
The Clinfoware System software is a 21 CFR Part 11 compliant EDC tool. It provides maximum flexibility in electronic Case Report Form (eCRF) design and management.
Clinfoware’s rapid implementation and dynamic query management system enable efficient quality control of data. It provides for data entry in multiple languages - English, Japanese, Chinese, German, Spanish, French, Portuguese.
Periodic reports, alerts and comments provide investigators and study coordinators with all the tools required for proactive study management.
Advantages of EDC systems:
- No CRF storage
- Allows for secured data transfer with real-time access to data
- Tracks CRF design with flexibility in layout
- Provides for final sign-off of captured data via e-signature
- Part 21 CFR Part 11 compliant automatic tracking (audit trail) of queries, comments and data changes
- Reduces duplicate queries on multiple CRFs
- Provides for batch loading of lab data and normal ranges
- Provides for reusable data formats
Paper Based Studies
Clinical Data Management
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