Clinical Data Management
Phase III and Late phase studies
Clinical Data Management That Makes Data Meaningful
The goal is always the same: Generation of a clean, fully integrated scientific database, ready for statistical analysis. Before we even begin to capture data, We focus on the questions that need to be answered and the goals that need to be achieved. That way we know up-front what data to collect and how to organize it during the collection process. The process for projects begins with the preparation of a Project management plan covering in detail the project organization, the project and work plan.


Then we choose the most appropriate technology to capture and store the data with optimal speed and quality, for clean, clear database demanded by bio-staticians and their computers. Our data management team can target paper-based, and EDC-based systems. From the initial handling of case report forms to completion of the database, our standard operating procedures assure a degree of worldwide consistency, completeness and accuracy.
Supported by our leading-edge data management systems and integrated SOPs, our CDM staff can fulfill unique project requirements, such as:
- Quick database set-up
- Sponsor-defined CRF and DCF management rules
- Customized query wording for clarity and conciseness
- Accelerated query management
- Unscheduled data reviews
- Study time line changes
- Changes to Protocol, CRF Template and project specifications
And that's what makes the difference between a confusion of numbers and a clear interpretation of outcomes.

Data Management Methodology
The following is a summary of our data management services and procedures:
- Project-specific data management standards and SOPs
- Database definition
- Database security
- Data entry screens
- Initial programming and query wording
- Testing and locking data validation plan
- Periodic re-testing
- Ongoing data entry from CRF – single or double entry
- Data entry cleaning
- Review of marginal notes on CRF and Data Alerts
- Evaluating medical and scientific consistency of data
- Periodic validation of CRF data
- Flexible query routing
- Accommodating 3rd party queries
- Query and resolution management over the Internet
- Database transfer in Sponsor defined formats
eCRF design and implementation.
Data Management Plan
Database Design
Data Validation Plan
Data Entry (paper)
Medical/Science Review
Data Validation and Query Management
Database Lock and Audit
Database Documentation & Release