SCORIS (SCOPE Reporting Information System) delivers a fail-safe reporting function with automated safety reporting and tracking to ensure all national safety reporting requirements are met for all key stakeholders, such as regulatory bodies and investigators. SCORIS is ongoingly updated to allow SUSAR reporting compliance according to current laws and regulations at all times.
Automated safety reporting in accordance with defined rules including automated safety report tracking (audit trail)
Tracking and scheduling of national and local safety reporting requirements for all countries, such as reporting to ethics committees (ECs), regulatory authorities (RAs), investigators, marketing authorization holders, etc.
Safety reporting contact details: Tracking and review of all (ECs, RAs, local authorities, investigators, MA holder); information available across studies
Timeline management: Study approval and start dates as well as study end dates for setting reporting timelines at country level
Independent master safety database for storing safety reporting data
Flexible reporting routes: The method of reporting can be selected by investigators preference (fax or e-mail)
To discuss how we can support your project or for further information to SCORIS: