Automate distribution of Clinical safety reports and track overall compliance



The current processes for generation, tracking and dissemination of SUSARs are ad-hoc, resource intensive and rely largely upon ad-hoc tools such as e-mails and excel spreadsheets. This is highly inefficient and is prone to error resulting in business liability and risk from an inspection and audit perspective. Managing distribution of information internally and external to CROs, partners and others based on Study, products and blinded/un-blinded access for organizations with portfolio of studies and products is complex. With constant resource changes, organizations are required to track and ensure access level are correctly granted and removed for inspection and audit purposes.

Quartica’s solution can play a key role in centralizing, tracking and dissemination of SUSAR information. It will eliminate manual steps thereby reducing the chance for delays or errors. The roles based access control features tightly regulate access based on study, product and blinded/unblinded access levels. The system also allows organizations to maintain user list and access level reports for audit and inspection purposes.


Automate generation of Dear Investigator Letters.
Capture read receipts and audit of listings downloaded.
Automate notification of DILs to investigator worldwide including external CROs and partners.
Traceable security and roles with blinded and unblided access with defined time frames.

Ready to automate your SUSAR distribution process?


Key Features

  • Centralized tracking and dissemination of SUSAR updates.
  • Personalized notifications to distribution groups based on roles based access level.
  • Standardization of terminology and automation of data-entry.
  • Cumulative listings and reports based on product access.
  • Audit trails for tracking, notifications, responses, and supporting data management operations.
  • Executive dashboard views and distribution reporting.