Technology


CREOS adopted a friendly proprietary system (JAZZ®) for e-CRF, Safety and IWRS from a strategic partner.
By using the proprietary system our professionals provide full Pharmacovigilance Programs as well as safety management for clinical trials.

JAZZ SAFETY database
Web-based drug safety database for full service Pharmacovigilance
    • FDA 21 CFR Part 11 compliant
    • Data elements compatible with ICH E2B (R3) standards
      • Processing drug safety information from any source
      • Highly scalable safety process
      • Case management through a defined workflow
      • Duplication check function
      • MedDRA browser integrated
      • Export of CIOMS forms for notification to the Agencies
        • Medical Evaluation module
        • SAE form collection (24/7 fax also available)
        • SAE processing in the drug safety database, including medical terms codification (MedDRA), drug codification (WHO-DD) and narrative writing
          • Periodic status reports
          • SAE quality monitoring
          • Query management, contact & follow up
          • Individual SAE cases Medical assessment and recording
          • SAE monitoring and periodical cumulative safety assessment

JAZZ EDC
Web-based eCRF
            • 21 CFR Part 11 compliant
            • Web based; doesn’t need the PI installing any program
            • Works under Linux and under all Windows versions
            • Run under all browsers (Chrome, Explorer, Firefox, others)
            • Cab be managed in Spanish, Portuguese and English
            • Help desk available 24/7
            • Tailored design and implementation
            • IWRS integrated
            • Design and implementation of SAE forms, safety data base management, queries resolution, CIOMS
            • Data export to the server indicated by the Sponsor
            • Customizable edit checks
            • Query management module incorporated
            • Allows pages verification (monitor) / approval (PI)
            • Generation of reports (e.g. query reports, audit trail)
              • Training for sites and CRAs

JAZZ IWRS
                • 21 CFR Part 11 compliant
                  • Centralized randomization and treatment allocation
                  • Patient status tracking (e.g, screened, randomized, withdrawn) and dynamic e-mail notification to site, central lab., sponsor, etc.
                  • Allows a real-time monitoring of the site recruitment status for the sponsor
                  • Subject unblinding
                  • Management and communication of IMP inventory at the sites
                  • IMP expiration dates monitoring and automatic delivery of IMP usage reports
                  • Integration into eCRF