PV & RA division of SPER Market Research
Risk & Signal Management
At Viginovix, we know that patient safety is everything. The responsibility of ensuring that medicines are safe, effective, and well-monitored doesn’t stop once they’re approved—it’s an ongoing commitment. Our Risk & Signal Management services are designed to help pharmaceutical companies, biotech firms, and healthcare organizations detect safety signals early, manage risks effectively, and ensure regulatory compliance.
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We take a proactive approach to pharmacovigilance—because catching potential risks sooner rather than later can make all the difference. Whether it’s identifying new safety signals, balancing benefit-risk profiles, or responding to health authority inquiries, we provide the expertise and technology to keep your products safe and your patients protected.
Our Risk & Signal Management Services
Signal Detection & Management: Spotting Risks Before They Become Problems
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Every medicine carries some level of risk—but the key is knowing how to manage it. Our Signal Detection & Management service helps pharmaceutical companies track potential safety concerns before they escalate. We use a mix of cutting-edge analytics and expert medical reviews to analyze global safety data and identify early warning signs.
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Expert medical review to assess potential safety signals
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Regulatory-compliant reporting to ensure patient protection
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Ongoing monitoring and assessment to minimize risks
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"A single safety signal could change everything. We make sure it's spotted, evaluated, and managed before it affects lives"
Benefit-Risk Management: Balancing Safety & Effectiveness
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Every drug has benefits, and every drug has risks. Our job is to help you keep them in balance. We ensure that medications remain as safe as possible while still delivering the therapeutic benefits that patients need.​
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Comprehensive benefit-risk analysis throughout the drug lifecycle
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Development of Risk Management Plans (RMPs) for regulatory submissions
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Implementation of risk mitigation strategies to reduce potential harm
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Continuous monitoring to ensure that a drug’s benefits always outweigh its risks​​
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"Patients trust medicines to help them—not hurt them. We help you maintain that trust by keeping benefit-risk profiles in check."
US-REMS: Helping You Meet FDA’s Safety Requirements
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Some medicines need extra precautions to ensure their safe use. That’s where Risk Evaluation and Mitigation Strategies (REMS) come in. If your drug is required to have a US-REMS program, we’ll help you design, implement, and manage it seamlessly.
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End-to-end REMS development from planning to execution
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Support for all REMS components, including communication plans and patient education
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Collaboration with healthcare professionals to ensure compliance
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Ongoing assessment to adapt to real-world safety concerns
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"Navigating REMS requirements can be complex, but we make it simple—so you can focus on delivering safe treatments to patients."
Additional Risk Monitoring Plans: Going Beyond Standard Safety Measures
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For some medications, basic pharmacovigilance measures aren’t enough. That’s why we design customized Additional Risk Minimization Plans (ARMPs) to help pharmaceutical companies proactively address safety concerns.
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Tailored risk monitoring programs based on real-world data
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Educational programs for healthcare professionals and patients
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Customized tracking systems for high-risk patient populations
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Regular assessment and refinement of risk management plans
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"No two medicines are the same—so why should their safety plans be? We build custom solutions to ensure patient safety is never compromised."
Health Inquiries & Request-to-Question Responses: Providing Clear, Accurate Answers
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When patients, doctors, or regulatory agencies ask questions about a drug’s safety, they expect clear, accurate, and timely answers. Our team ensures that every inquiry is handled with precision and regulatory compliance.
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Rapid responses to health authority inquiries
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Expert medical assessments for complex safety concerns
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Development of standardized response templates for consistency
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​Ongoing support to ensure clear communication with all stakeholders
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"Safety isn’t just about data—it’s also about communication. We make sure that every question gets the right answer, at the right time."
Why Choose Viginovix for Case Management?
Proactive, Not Reactive – We identify risks early, so you can act before they become serious issues.
Technology Meets Expertise – Our solutions work alongside expert scientists and physicians to ensure accuracy.
Regulatory Confidence – We ensure compliance with FDA, EMA, MHRA, and other global health authorities.
Customized Approach – We tailor risk management strategies to fit the unique needs of each drug and company.
Patient-Centric Focus – Everything we do is about ensuring better outcomes for patients worldwide.