Automate Clinical Safety Reports
process within your organization

Clinical Safety Reports – ACOs, DSUR, SASR/SSR

Clinical Safety reports scheduling, management and distribution processes within organizations have been fairly ad-hoc, linear and rigid utilizing a combination of localized tools, manual steps and knowledge base from individual resources. The complexity of new regulatory standards, individualized local country requirements further complicates the overall end-to-end reporting processes. Changing regulations in different countries, new product registrations (and withdrawals) and resource turn-over introduces tremendous challenges to organizations to ensure global regulatory commitments to agencies are met in time. The lack of centralized system or knowledge base does not offer capabilities to optimize worldwide reporting thereby increasing the overall number of clinical reports. This increases the cost and resource needs within organizations.

Quartica’s solution can help manage the end-to-end semi annual clinical reporting process from scheduling to distribution and tracking of compliance metrics. The solution integrates regulatory knowledge base, company product portfolio and internal company processes to provide a centralized system. It provides automated, agile and proactive tools to organizations by reducing overall reports and ensuring regulatory commitments are met on time in a cost effective manner.

Key Features

Manage end-to-end semi annual reporting process including planning, scheduling, report authoring and submission tracking
Estimate resource and budget needs based on upcoming submissions and approvals
Generate reporting obligations worldwide based on product portfolio
Collaborate with other departments, partners and local affiliates
Optimize reporting plans utilizing harmonization strategies to reduce total overall reports
Track decision log, review and approval history for complete traceability
Manage Review and Approval workflow process
Configure organizational specific strategies to fine tune reporting plans
Ensure conformance to standards, templates and regulations.

Benefits

Automate generation of semi annual safety report schedule and planning worldwide

Automate authoring of semi annual clinical safety reports e.g. (SASR, SASR LL, Clinical SAE LL etc.)

Configuration tailored to organization internal standards and external regulations

Support for integration with existing systems such as EDMS, CTMS and others

Ready to automate your SASR business process?

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