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Postmarketed Pharmacovigilance Services > Case Intake, Processing, Submissions & Medical Review

Case Intake, Processing, Submissions & Medical Review

200,000

Annual Safety Intakes

99.99%

Submission Compliance

>30%

Savings through automation

Efficient Case Intake, Triage, and Medical Review Services
At Soterius, we provide comprehensive case management services, expertly handling Individual Case Safety Reports (ICSRs) from intake through triage, processing, medical review, and regulatory submissions. Our advanced Intake Platform seamlessly integrates with any safety database, including ARISg®, ARGUS®, and client-hosted systems, streamlining data capture from diverse forms and languages. This integration ensures rapid, accurate intake and processing, reducing turnaround times and enhancing regulatory compliance.

Physician-Led Quality Assurance and Triage
Our experienced physician-led team ensures meticulous triage and thorough medical reviews for every case, maintaining exceptionally high standards for quality and compliance. By combining clinical expertise with our automated workflows, we consistently achieve quality scores above 99.9%. Our proactive approach to triage promptly identifies and addresses critical safety information, ensuring precise, compliant reporting for spontaneous, clinical, literature-based, regulatory, and legal cases.

Automation-Enhanced Cost Efficiency and Compliance
Leveraging advanced automation tools, our intake and case processing services significantly reduce operational costs by at least 30%, while maintaining exceptional accuracy and compliance. Our platform’s ability to handle any form or language ensures seamless global operations, improving efficiency, minimizing manual intervention, and significantly enhancing data integrity. With Soterius, clients benefit from superior cost-effectiveness, regulatory confidence, and streamlined global safety management.

Integrated Intake Platform: Seamlessly compatible with ARISg®, ARGUS®, and other safety databases.
Multilingual, Multi-Format Support: Efficient intake and processing of ICSRs in any form or language.
Physician-Led Medical Reviews: High-quality triage and rigorous medical assessments ensuring accuracy and compliance.
Automation-Driven Efficiency: Cost reductions of at least 30%, achieving industry-leading compliance and accuracy.
Consistently High Quality: Quality scores above 99.9%, streamlining global safety case management.