A Global CRO

 

Data Management

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