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.

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 traceability and document evidence of who entered, modified data and reason for modification. We also have capability to integrate data from external sources such as LAB data, patient diary, ECG and MRI results.

Statistical Analysis

Ph.D. level statisticians and highly skilled programmers understand data correctly and employ statistical methodologies and data analysis techniques to analyze data and test study objectives.

Sample of some of the analytical tools which we use:

• Regression Analysis
• Time Series Analysis
• Statistical Power Analysis for Sample Size determination
• Multivariate Analysis
• Non-parametric Methods