Regulatory Affairs & Safety

• Utilize the SimpleCTMS Regulatory tab to complement country startup activities and study startup timelines. Items include regulatory submission planning by agency, country, and document type. Track planned versus actual approvals at country and site level and use document repositories as needed. Proactively define regulatory document package requirements for site activation by country.
• The SimpleCTMS Safety tab provides secure repositories to store and access IND Safety Reports by type and date, individual SAE reports and related queries, and weekly status reports. CRAs and Regulatory Associates can quickly identify new SUSARs reports and plan and track required agency submissions and use built in dashboards as a guide.