Automate Semi Annual Clinical Safety Reports process within your organization



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.


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 (SOPs, templates, format, style, etc.) and external regulations
Support for integration with existing systems such as EDMS, CTMS and others

Ready to automate your SASR business process?


Key Features

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