Database Design

Database Design:

Our database designers have many years of experience in developing and implementing CFR Part 11 compliant and efficient databases in our proprietary system. Databases are developed and independently tested and documented for all functionality before deployment to production. Audit trail is always built in for tracebility of who entered, changed the data and why. We also have capability to integrate data from external sources such as LAB data, patient diary, ECG and MRI results.

Data Validation Checks for most complete and accurate data capture:

To capture most accurate and reliable clinical data, we design and program data validation checks to validate single item as well as multiple item data consistency. Edit check programs generate data queries for sites to answer and clarify/provide missing or discrepant data.

Data Queries:

Our Data Management team generates and reviews all generated data queries before sending out to sites for clarification. Queries consist of queries from automated processes as well as manual reviews. Responses and clarifications received from investigators or sites are documented and correct data is entered in database. Tracking and documentation allows us to be audit and inspection ready.

Additionally we can also provide patient profiles and data listings as necessary for performing medical review.

CRF Design:

A case report form (CRF) is a data collection tool used in clinical trials to capture all information as per trial protocol. A well-designed CRF allows optimal data collection which in turn benefits other facets of data management and statistical analysis. A well structured CRF helps in design of an efficient database and data validation processes as well as statistical analysis of data.

Using proper CRF design guidelines GCM will design your CRF for optimal collection of data as per study protocol requirements.

Some important features are:

• Design questions on CRF as per protocol requirements
• Avoid collection of misleading information
• Self-explanatory and investigator friendly
• Avoid repeat questions
• Easy to fill in
•  Requires minimal or no revision

Data Management Database Design Statistical Analysis