SCORIS (Scope Reporting Information System) provides you with a fail-safe reporting function with automated safety reporting and tracking to ensure all national safety reporting requirements are met for all key stake holders such as regulatory bodies and investigators. SCORIS also keeps you informed of all regulatory and scheduling requirements according to current laws and regulations as well as tracking and reviewing all contact details for safety reporting.
- Automated safety reporting according to defined rules with 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 reviewing of all safety reporting contact details (ECs, RAs, local authorities, investigators); information available across studies
- Timeline management of study approval and start dates; study-end dates captured for setting reporting timelines at country level
- Safety reporting data stored in an independent master safety database
- Reporting method can be selected by investigators (fax or e-mail)