Quality Data Services, Inc.
Data Management
Database designed with end results in mind; quality delivered
Data Management
Data Managers
Our office based Data Managers provide full service from database development to database lock. Our Data Management services are governed by rigorous SOPs and comply with ICH, GCP, and FDA 21 CFR Part 11 regulations. QDRx provides our Data Management Team a state of the art, fully compliant EDC system to conduct data review and manage queries in real time. It also ensures data accuracy and integrity with real time reporting. Our Data Management services are tailored to fit your clinical trial needs: From individual stand-alone services to fully-functional outsourcing.
Services from Inception to Completion:
- Data Specifications
- Database Development and Validation
- Data Management Plan
- Data Review
- 3rd Party Vendor Data Reconciliation
- Dictionary Coding
- Database Closure
- Data Transfers
- eCRF Archival
Process
Database Go-Live Timelines
| Final Protocol | Day 0 |
| Final Database Specifications/Source Documents | Day 0 |
| Metadata Created | Day 2 |
| Layouts Completed | Day 4 |
| On-Entry Checks Coded | Day 5 |
| Editing Ground Rules Drafted | Day 6 |
| Entry Testing Completed | Day 8 |
| Editing Ground Rules Finalized (Client Review) | Day 9 |
| Exportable Views Created | Day 9 |
| Editing Programs Coded | Day 12 |
| Validation of Editing Programs Completed | Day 15 |
| Client User-Acceptance Testing Completed | Day 15 |
| Database Go-Live | Day 16 |
Data Review
- On-Entry Validation
- Data Issues (Pre-Monitoring)
- mQueries (Monitor Issued)
- eQueries (Data Management Issued)
- Global Review
