Data-Driven Post-Market Safety and Surveillance
Ensuring patient safety and compliance through advanced Analöytics tools for Pharmacovigilance (PV) and Post-Market Surveillance (PMS).
- Monitoring the safety and performance of medical products post-market is crucial for patient safety, ongoing regulatory compliance, and overall product lifecycle management. Post-Market Surveillance (PMS) and Pharmacovigilance (PV) are essential components of ensuring that medical products continue to meet safety standards after reaching the market.
- At CompliXMed, we leverage Data-driven tools to streamline post-market data collection, signal detection, and regulatory reporting processes. By automating the analysis of vast datasets—such as patient records, adverse event reports, and literature—we provide timely and accurate safety insights, enabling you to stay ahead of safety concerns, reduce risk, and comply with evolving regulatory standards.
- Our Data-Driven PMS & Pharmacovigilance service reduces detection time, enhances reporting accuracy, and ensures compliance with regulatory authorities, ultimately improving your company's post-market safety measures and maintaining a high standard of patient care.
Core Services
Early Identification of Safety Signals
We utilize advanced Data and AI-powered algorithms to detect safety signals early, helping you respond proactively and mitigate risks. By analyzing vast and complex datasets—such as patient records, adverse event reports, clinical trials, and literature—our systems can identify potential safety concerns before they escalate into major issues.
• Data-driven signal detection to identify potential safety issues early in the lifecycle of a product.
• Data mining from diverse sources including clinical databases, spontaneous reports, and scientific literature.
• Advanced algorithms that reduce the time needed to detect new adverse events, allowing for rapid intervention.
• Continuous learning from new data sources to improve signal detection accuracy over time.
Streamlining Case Processing and Reporting
Our automated reporting and case management systems simplify the entire process, from collecting adverse event data to submitting reports to regulatory authorities. By reducing manualerrors and automating workflows, we help ensure that your company remains compliant with global pharmacovigilance standards and regulations.
• Automated case management to reduce the need for manual data entry, minimizing human error.
• Integration with existing pharmacovigilance systems for seamless data collection and reporting.
• Efficient and accurate generation of regulatory reports, including CIOMS forms and PSURs (Periodic Safety Update Reports).
• Real-time tracking of cases, including the status of ongoing reports and regulatorysubmissions.
Ensure Full Compliance with Regulatory Authorities
Data and AI-driven reporting tools help ensure your company meets global regulatory requirements, including those of the EMA, FDA, and other authorities. We streamline the reporting of adverse events, and provide continuous updates to ensure timely and accurate submissions, keeping you fully compliant with pharmacovigilance regulations.
• Timely and accurate regulatory submissions, including PSURs, DSURs (Development Safety Update Reports), and CIOMS forms.
• Automated compliance checks to ensure your reports meet regulatory requirements before submission.
• Real-time reporting and updates on compliance statuses for greater peace of mind.
• Dedicated support for regulatory submissions to reduce administrative burdens and ensure smooth processes.
Evaluate Product Risk-Benefit Profiles in Real-Time
We provide ongoing risk-benefit analysis to evaluate the safety profile of your products in the market. By continuously assessing safety signals and performance data, we help you make data-driven decisions that optimize product lifecycle management and inform future regulatory submissions.
• Real-time assessment of the product’s risk-benefit profile based on updated safety and efficacy data.
• Data-backed recommendations to inform decisions on product recalls, label changes, or new regulatory filings.
• Integration with real-world data from clinical settings to assess ongoing safety and efficacy post-market.
• Optimization of regulatory submissions based on updated risk-benefit assessments, ensuring that your products remain in compliance with the latest regulatory guidelines.
Benefits of Our Data-Driven PMS & Pharmacovigilance Service
Faster Detection of Safety Signals:
AI algorithms significantly reduce the time needed to detect potential safety issues, ensuring timely intervention.
Improved Compliance:
Automated reporting and compliance support ensure you meet global regulatory standards and avoid non-compliance risks.
Enhanced Patient Safety:
Early detection of safety signals allows for quicker corrective actions, reducing risks to patient health.
Streamlined Case Management:
Automation of case processing and regulatory reporting improves efficiency and accuracy, reducing human error.
Ongoing Risk-Benefit Monitoring:
Real-time evaluation of the risk-benefit profile ensures that your product continues to meet safety standards and remains compliant with evolving regulations.
Ensure Post-Market Safety with AI
Stay ahead of safety concerns and ensure ongoing regulatory compliance with Data-driven Post-Market Surveillance & Pharmacovigilance. Let us help you enhance patient safety, reduce risk, and streamline your post-market data management processes.