Automate your DSUR business 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 and harmonization initiatives 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 aggregate reports. This increases the cost and resource needs within organizations.

Quartica’s solution can help manage the end-to-end process 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 planning and scheduling of Clinical Safety Reports worldwide
Automate authoring of development aggregate reports e.g. (DSUR, Interim DSUR, Abbreviated DSUR, Cover Letter etc.)
Configuration tailored to organization internal standards (SOPs, templates, format, style, etc.) and external regulations
Leverage existing investments by integrating with existing systems such as PV Databases, EDMS systems and others

Ready to automate your Clinical Safety reporting process?


Key Features

  • Manage end-to-end clinical 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.