Data Management

Quality and integrity of data collected during clinical trial reflects the true quality, potential, and human benefits of a medical device. We build well organized, well documented, 21 CFR Part 11 compliant database and data capture system to facilitate capture of most accurate data. Our in-house data entry staff will enter your data in database system and data is always stored securely.

Our clinical data management service includes:

• Data Management Plan
• Case report form (CRF) design, development and review
• Database design and development
• Data Entry
• Independent double-data entry
• Data Validation Checks for most complete and accurate data capture
• Data query management and resolution
• Full database QC
• Dictionary coding for Adverse Events and Concomitant Medications
• Database lock
• Study status reporting throughout the study
• Export of clean data files to other formats for analysis