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Pharmacovigilance & Safety > Case Intake Processing and Medical Review

Case Intake, Processing, and Submission

180,000

Annual Safety Intake

99.9%

Submission Compliance

>30%

Savings through automation

Case Processing Services

As an outsourced service, Soterius prepares Individual Case Safety Reports (ICSR) that are spontaneous, clinical, literature-based, regulatory, or legal.

Clients are assigned a specialised team, with physicians examining cases during triage and case completion workflow steps to assure high-quality case management. We provide full management for ARISg®, ARGUS®, and other safety database systems, as well as support for client-hosted safety databases.

Assuring at least 30% cost reduction when we combine our automation tools, we lead the industry in compliance and efficiencies. Our case compliance and quality scores above 99.9% across all clients.

Learn About Medical Strategy Integration with Safety Submissions

  • Physicians Perform Triage of Cases: Experts review cases at important stages to ensure quality.
  • In-House Technology & Automation Solutions: Integrated tech boosts efficiency.
  • Dedicated Teams: Less than 5% staff turnover, ensuring consistency.
  • Global Submission Capabilities: Handling case submissions in over 100 countries.
  • Integrated Medical Information Response: Quick and effective processing of spontaneous cases.
  • Country-Specific Literature Search: Extensive safety monitoring across more than 100 countries.