Robust automated safety reporting
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.
- Tracking and review of all safety reporting contact details (ECs, RAs, local authorities, investigators); information available across studies
- Timeline management of study approval and start dates as well as study end dates for setting reporting timelines at country level
- Safety reporting data stored in an independent master safety database
- The method of reporting can be selected by investigators (fax or e-mail)
To discuss how we can support your project or for further information to SCORIS: