Compliance isn’t distribution. It’s governance across complex relationships. 

Quartica MARS applies configurable regulatory intelligence across studies, compounds, countries, and blinding structures to ensure safety notifications are distributed accurately and compliantly. Generate, distribute, track acknowledgements, and produce inspection-ready reports in one platform.

Compliance isn’t distribution. It’s governance across complex relationships. 

Quartica MARS applies configurable regulatory intelligence across studies, compounds, countries, and blinding structures to ensure safety notifications are distributed accurately and compliantly. Generate, distribute, track acknowledgements, and produce inspection-ready reports in one platform.

Automate Global Safety Notifications including SUSAR/DILs
with Regulatory Intelligence

Automate Global Safety Notifications including SUSAR/DILs with Regulatory Intelligence

Safety notifications are shaped by study scope, site activation timing, product and compound relationships, country-level reporting requirements, and blinding structures. As portfolios expand, these interdependencies become increasingly difficult to manage consistently.

Many organizations rely on spreadsheets and email to manage distribution. Others adopt notification portals that centralize document posting and tracking. 
While these approaches improve visibility, they often depend on static rule configuration and manual interpretation of complex regulatory relationships. 

The risk remains: 

  • Over-reporting across studies or geographies 
  • Under-reporting due to incorrect applicability logic 
  • Version confusion during recalls or corrections 
  • Limited traceability between rule configuration and actual distribution 
  • Manual reconciliation of acknowledgements

Quartica MARS goes beyond centralized distribution.

It embeds configurable, version-controlled regulatory governance directly into the notification framework. Distribution logic is applied dynamically across study, site, product, compound, and blinding structures with full traceability from rule configuration through investigator acknowledgement and recall lifecycle management. 

This ensures every notification is:  

  • Applied according to the correct regulatory rule set 
  • Governed across complex cross-trial relationships 
  • Fully auditable from issuance to close-out 
  • Managed as part of an integrated safety ecosystem 

Advantages of using Quartica MARS for Safety Notifications

Configurable Regulatory Rule Engine 

Apply version-controlled reporting rules by Sponsor, Study, IMP, country, and product with full traceability to each distribution decision. 

Complex Relationship Management

Govern distribution logic across Study, Site, Product, Compound, and cross-trial structures to prevent over-reporting or under-reporting.

Intelligent Acknowledgement Management 

Automated reminders, escalation workflows, and compliance dashboards make it easier for investigators to acknowledge and harder for acknowledgements to be missed. 

Failed Notification Handling & Retry Logic 

Automatically detect failed distributions, trigger retries and notify stakeholders — ensuring delivery integrity. 

Inspection-Ready Audit & Read-Only Access

Provide inspector-specific access modes, immutable audit exports, and non-editable historical records. 

Full Lifecycle Management 

Support study close-out, decommissioning, data export, GDPR-aligned retention, and secure archival processes. 

Ready to automate your SUSAR distribution process?

Frequently Asked
Questions

How does Quartica MARS prevent over-reporting or under-reporting? 

Quartica MARS uses configurable regulatory intelligence logic based on study participation, country requirements, blinding status, and cross-trial applicability. This ensures investigators receive only the notifications required under governing regulations and protocol scope. 

Quartica MARS automatically offboards investigators from their previous site and removes access to prior site communications. When onboarded to a new site, they begin receiving active notifications aligned to that site’s study scope and regulatory rules. For newly activated sites, distribution is governed by the Site Initiation Visit (SIV) date. Where required, historical notifications are made securely available in the investigator portal as a “gap pack,” without unnecessary re-distribution ensuring compliant access with full audit traceability.

Yes. Quartica MARS allows configuration of study-only or cross-trial applicability, enabling compliant dissemination across related protocols where required. 

Role-based access controls enforce strict content segregation, ensuring appropriate visibility aligned with study design and regulatory requirements. 

Yes. Quartica MARS integrates via secure REST APIs and supports integration with safety databases, RIM, CTMS, and enterprise platforms while preserving existing investments. 

Every distribution decision, rule application, acknowledgement, and configuration change is logged with full audit trail and reporting visibility. 

Traditional portals distribute documents. Quartica MARS applies structured regulatory intelligence to determine who should receive what, when, and why, with traceable rule logic and lifecycle connectivity. 

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