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Customer centric, innovative, and cost-efficient processes for comprehensive drug safety and PV tech solutions.
Quality Management System
Soterius provides services related to global safety, medical affairs, regulatory and technology enabled solutions to clients globally. All of our internal processes are designed with ...
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Aggregate Reports
Unlocking a legacy of proficiency: Our adept team boasts substantial experience in crafting comprehensive aggregate reports. Delve into our journey through the snapshots below: Soterius ...
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Case Processing
Our team is trained with a sharp focus on quality so that any information that enters the safety database meets its end-target, i.e., the most ...
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Regulatory Intelligence
The regulatory intelligence process at Soterius includes identifying relevant regulatory information from various sources and communicating the information to the key stakeholders for analysis with ...
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Risk Management Plan
A risk management plan (RMP) describes the current knowledge about the safety and efficacy of a medicinal product and provides key information on plans for ...
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Signal Detection and Analysis
Soterius can support sponsors in signaling activities for the molecules under clinical investigation. In carrying out this work, our team will review publications identified from ...
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Quality Assurance
The Quality Assurance team at Soterius develops and maintains internal and external audit calendars in consultation with the functional head and other key stakeholders (e.g., ...
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SAE Reconciliation
At the juncture of GCP and GVP is the process of SAE Reconciliation, which ensures that the clinical database and pharmacovigilance database are in sync ...
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