Pharmacovigilance
Pharmacovigilance Automation for Life Sciences
At Mushroom Solutions, we deliver next-generation Pharmacovigilance (PV) Automation Solutions that help life sciences organizations enhance patient safety, ensure global regulatory compliance, and accelerate safety reporting across the entire drug lifecycle. Our AI-powered PV platform integrates seamlessly with existing systems to monitor, assess, and manage adverse events (AEs) with unmatched efficiency, accuracy, and transparency.
Our Pharmacovigilance Solutions
Mushroom Solutions unites Artificial Intelligence (AI), Machine Learning (ML), and intelligent automation with regulatory expertise to streamline every stage of the drug safety process — from case intake to global submissions.
Case Forms Creation
- Capture and manage ADR, ICSR, and SUSAR cases with automated validation for data accuracy and completeness.
- Streamline data intake from clinical trials, post-market surveillance, literature, and partner systems.
Literature Review
- Automatically search PubMed, journals, and regulatory databases for disease, product, or keyword.
- Link published evidence directly to active safety cases for traceable documentation.
Narrative Generation
- Auto-generate CIOMS-compliant narratives from structured and unstructured data sources.
- Maintain consistency, accuracy, and audit readiness across submissions.
Case Intake Automation
- Extract AE information from emails, PDFs, EHRs, and call logs using DocuGenX, our proprietary AI document intelligence engine.
Gateway Submissions
- Auto-generate E2B (R3) XML safety reports for FDA, EMA, and global health authorities.
- Enable seamless gateway validation, integration, and schema control.
Signal Detection
- Detect emerging safety patterns through AI/ML-driven analytics.
- Empower proactive risk mitigation and timely safety signal management.
Compliance & Reporting
- Regulatory Readiness Checks: Schema validation, MedDRA version control, WHO-DD mapping, and completeness reviews.
- Quality Controls: Duplicate detection, causality verification, and comprehensive audit trails for transparency and compliance.
Core Value Highlights
Our Pharmacovigilance platform delivers measurable impact across safety, speed, and compliance:
- Efficiency: Reduce manual effort by 40–60% with intelligent automation.
- Speed: Accelerate submissions through real-time case linkage and validation.
- Accuracy: Ensure consistent, error-free, and validated safety data.
- Compliance: Stay fully aligned with ICH E2B(R3), FDA, and EMA standards.
- Insight: Detect risks early and gain data-driven visibility into global safety trends.
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Case Study: Narrative Automation for a Global CRO
Challenge : A global Clinical Research Organization (CRO) faced frequent delays and inconsistencies in CIOMS narrative generation due to manual, error-prone workflows — leading to high compliance risk and operational inefficiency.
Solution : Using Mushroom Solutions’ DocuGenX platform, the CRO deployed an AI-powered narrative automation solution combining Generative AI, NLP, and ML to automatically create, validate, and submit narratives aligned with ICH E2B(R3) standards.
- 60% faster submissions
- >99% narrative accuracy
- Global regulatory compliance (FDA & EMA)
- Reduced manual workload and improved data utilization
- The CRO transformed its manual, resource-intensive reporting process into a digital, compliant, and intelligent Pharmacovigilance workflow, achieving faster submissions, improved accuracy, and higher operational efficiency.
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Ready to enhance your Pharmacovigilance operations? Reach out to Mushroom Solutions to learn more about our tailored solutions for the life sciences industry. Our team of experts is here to assist you in ensuring the safety and efficacy of your pharmaceutical products