 Clinical Trial and Data Management |
| Protocol development and review |
| Case Report Form (CRF) design and review |
| Electronic Data Capture System |
| Data management plan |
| Data coding & Database design |
| Data entry and verification |
| Data auditing, query, and computerized edit checks |
| Web-based data management systems, EDC |
| Randomization, including dynamic assignment |
| Statistical analysis plan |
| Executive and full statistical reports |
| Representative for client at FDA meetings |
