Amarex offers both electronic data capture (EDC) and paper based solutions (CRF) that are customizable and cost-effective for clinical trial data management. The following services are provided following ICH-GCP and regulatory guidelines using controlled and secure computing environments with validated software and systems (21 CFR Part 11 compliant):
- CRF/eCRF design and annotation
- Data management plan writing
- Database design and maintenance
- User Acceptance Testing
- Data processing and quality control, including third party data integration and cleaning (e.g. central lab data, eDiaries, etc.)
- Ongoing safety data review and reconciliation of adverse events and serious adverse events
- Data validation and review
- Edit checks and data queries
- Database QA acceptance sampling prior to database lock, and additional database checks
- Adaptability when working with any EDC provider.
- Secure web portal for real-time access to study progress reports, query reports, subject data listings and summary tables, etc.
- Ongoing support for users of data management systems and tools, including user training and helpdesk operation
- Data migration
- Database lock and archival