Clinical Data Management:

Management of clinical data is the development and execution of building, developing rules and functioning that properly maintain the full data lifecycle needs of an organization. Integrated data and information platform, data standardization, GCP compliant data validation functions, and streamlined data handling processes are critical to the successful management of clinical data management trials. Also, managing data operations face various challenges because continuous pressure to reduce cost while having to meet all the requirements. Data management experts assist in the selection, implementation and validation of integrated data and information platform. These platforms make effective transfer of clinical data from an operational state into a dynamic repository that are beneficial to complex data analysis.
Management of clinical data includes under given contents:

• Data Management Plan
- Project-specific data management standards
• Data Validation Plan
- Initial programming and query wording
- Testing and locking data validation plan
- Periodic re-testing
• Data Entry
- Ongoing data entry from CRFs – single or double entry
- Data entry cleaning
• Database Design
- Database definition
- Database security
- Data entry screens
• Medical/Science Review
- Review of marginal notes on CRFs and Data Alerts
- Evaluating medical and scientific consistency of data
• SAE Reconciliation
- Reconciliation based on central SAE database vs. study database
• Medical Coding
- Coding of adverse events
- Coding of concomitant drugs
• Data Validation and Query Management
- Periodic validation of CRF data
- Flexible query routing
- Accommodating 3rd party queries
- Query and resolution management over the Internet
• Central Lab Database Imports
- Incorporating 3rd party databases
• Database Lock and Audit
- Interim and final database locks with associated documentation
• Database Documentation & Release
- Database transfer in Sponsor defined formats with detailed documentation