PV & RA division of SPER Market Research
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At Viginovix, we understand that managing Individual Case Safety Reports (ICSRs) is more than just a regulatory obligation—it’s a responsibility toward patient safety and global health. Our ICSR Management services are designed to ensure meticulous case processing, compliance with stringent global regulations, and seamless data integrity, all while leveraging the latest technology and expert insights.
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Whether you're a pharmaceutical company, biotech firm, or contract research organization (CRO), our team of experienced professionals is here to handle every aspect of case processing, literature screening, medical review, and regulatory submissions. We take the complexity out of pharmacovigilance (PV) data management, so you can focus on developing safe and effective treatments.
Case Management
Our Case Management Services
Case Management: Handling Every Case with Precision
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Each adverse event (AE) or serious adverse event (SAE) report holds critical information that can impact patient safety and drug development decisions. Our case management team ensures that every report is processed with utmost accuracy and efficiency.
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End-to-end case processing – from data intake to final submission
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Stringent quality control to ensure accuracy and completeness
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Real-time tracking and compliance monitoring
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Seamless exchange of safety data with partners and regulators
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"Our case management solutions empower life sciences companies with faster, more reliable, and compliant processing of safety data."
Literature Review & Screening: Identifying Safety Signals Proactively
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In the vast ocean of scientific literature, journals, and global databases, safety signals can emerge from anywhere. Our literature screening experts systematically monitor, assess, and report relevant findings to ensure early detection of adverse events.
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AI-powered automated screening tools to process thousands of publications efficiently
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Expert manual curation for in-depth analysis
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Timely signal detection and regulatory reporting compliance
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Coverage of worldwide medical databases and journals​​
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"By staying ahead of the curve in literature monitoring, we help our partners make informed safety decisions faster."
SAE & SUSAR Management: Managing Critical Safety Data with Expertise
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When a Serious Adverse Event (SAE) or a Suspected Unexpected Serious Adverse Reaction (SUSAR) occurs, time is of the essence. We ensure swift assessment and reporting to health authorities, sponsors, and investigators, minimizing risks and ensuring compliance.
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Real-time tracking of SAEs and SUSARs for early risk identification
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Medical evaluation and causality assessment by expert reviewers
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Expedited reporting to regulatory bodies in line with global guidelines
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Customized SAE/SUSAR management solutions for clinical trials and post-market surveillance
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"Serious cases demand serious attention. Our team ensures no critical safety event goes unnoticed or unreported."
Migration of PV Data: Seamless, Secure, and Error-Free
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Pharmacovigilance data migration can be complex, time-consuming, and prone to errors. Our PV data migration experts help pharmaceutical companies transition from legacy systems to modern, compliant databases without compromising data integrity.
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End-to-end migration planning and execution
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Automated tools to ensure data accuracy and completeness
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Validation and reconciliation of migrated data
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Regulatory compliance with E2B standards
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"Data is the backbone of safety. We ensure it moves securely, accurately, and seamlessly."
Medical Review of ICSRs: Ensuring Clinical Accuracy
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A thorough medical review is crucial to ensuring that safety data is clinically relevant, well-analyzed, and accurately reported. Our team of experienced healthcare professionals and pharmacovigilance specialists carefully evaluate each ICSR to ensure that all aspects, including causality, expectedness, and seriousness, are appropriately assessed.
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Expert-led medical case review
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Causality assessment and risk evaluation
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Regulatory compliance checks before submission
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Detailed narrative analysis for clinical accuracy
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"We don’t just process safety reports—we analyze them with a keen clinical eye, ensuring every report is meaningful and precise."
Submissions: Timely & Compliant Global Reporting​
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Submitting ICSRs to regulatory authorities on time is critical for compliance. Our submission services ensure that your safety reports reach the right regulatory bodies without delay, in the required formats and within compliance timelines.
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Automated electronic submissions (E2B) and manual submissions
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Regulatory compliance with global agencies (FDA, EMA, MHRA, PMDA, WHO UMC, and more)
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24/7 support for urgent case submissions
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Tracking and audit readiness
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"Regulatory compliance doesn’t have to be a challenge. With Viginovix, your submissions are in safe hands."
Why Choose Viginovix for Case Management?
Regulatory Excellence – We ensure 100% compliance with FDA, EMA, MHRA, and global pharmacovigilance regulations.
Industry Experts – Our highly skilled medical professionals, PV specialists, and regulatory experts handle cases with precision and expertise.
Tailored Solutions – Whether you're a startup biotech or a global pharmaceutical leader, we customize our ICSR services to fit your specific needs.
24/7 Compliance Support – Our team is always available to ensure timely submissions and real-time case tracking.