Data Management
Frontage uses Oracle Clinical™, a state-of-the-art, validated data management system, and complies with 21 CFR Part 11 Electronic Records regulations. Our team also has experience with Clintrial™ and etrials QuickStudy Capture™.
In addition to a manual clinical review of case report forms review prior to data entry, customized electronic edit checks are built into each database. Independent double-key data entry is performed and a complete audit trail is maintained for all data entries, corrections and clarifications and all data query reports and resolutions. Key efficacy and safety variables are verified against the case report forms.
