SIGNAL MANAGEMENT

Revolutionizing Safety Monitoring with AI-Driven Signal Management

Comprehensive Signal Solutions for Drugs, Devices, and Vaccines

Address Critical Challenges and Simplify Safety Monitoring with our AI-Driven Signals Platform. Streamline workflows, enhance accuracy, ensure regulatory compliance, and always stay audit and inspection ready.

Volume of Safety Data

Manage vast safety data from multiple sources seamlessly.

Missed Signals

Detects critical safety signals early to mitigate risks.

Operational Inefficiencies

Automate workflows to eliminate redundancies and delays.

Audit Readiness

Automate workflows for instant compliance-ready reports.

DATA AGGREGATION

Consolidates safety data from diverse sources for seamless analysis and decision-making.

NEAR REALTIME ANALYSIS

Delivers actionable insights with advanced analytics powered by AI in near real-time.

WORKFLOW AUTOMATION

Streamlines the signal management process, reducing manual effort and improving efficiency.

Customized for your Business needs

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Algorithm Selection

Choose or customize algorithms tailored to your unique data and requirements.

Enriched Data

Add epidemiology data for deeper insights and comprehensive safety validation.

Flexible Sources

Integrate diverse input sources, including internal systems and global datasets.

Custom Reporting

Generate business-specific reports with tailored formats and actionable insights.

 
IMDRFAccuracy

Why Choose Our Solution?

1. Faster Anomaly Detection

Identify patterns and anomalies with advanced AI-powered analytics, ensuring quicker and more reliable signal detection for enhanced patient safety.

2. Continuous Safety Monitoring

Maintain round-the-clock vigilance with our platform’s real-time signal detection capabilities, keeping your safety monitoring proactive and compliant.

3. Audit-Ready Insights

Streamline audit and inspection processes with automated workflows and compliance-ready reports, enabling informed decisions and stress-free readiness.

4. Scalability and Accuracy

Scale effortlessly to handle increasing data volumes while maintaining high accuracy, ensuring consistent performance across diverse business needs.

 

GxP COMPLAINCE

Meets established guidelines.

CUSTOM EXPORTS

Export data in Excel format.

AUDIT TRAIL

Tracks actions for transparency.

100% SAFE & SECURE

Can be deployed on Client's cloud

How it works?

Transforming Medical Device Complaint Coding with Speed and Precision.

01.

DATA AGGREGATION

Collect and harmonize data from diverse sources like global health agencies, literature, and internal systems for a unified view.

02.

SIGNAL DETECTION

Utilize advanced analytics to detect, validate, and prioritize safety signals through qualitative and quantitative methodologies.

03.

ACTIONABLE INSIGHTS

Generate customized reports and leverage interactive dashboards for informed decision-making, compliance, and audit readiness.

SIgnalProcessing

Transform Signal Management Today

Experience the power of our advanced Signal Management platform for drug, device and vaccine. Streamline workflows, ensure compliance, and enhance safety. 

Comprehensive Quantitative Signal Detection

Empowering signal detection with 20+ advanced algorithms for precise and comprehensive quantitative evaluation.

Disproportionality Analysis

Leverages advanced statistical measures such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) to identify safety signals effectively.

Customizable Criteria

Supports tailored thresholds like PRR ≥ 2, Chi-square ≥ 4, and N ≥ 3, allowing flexible and precise signal detection.

Regression Models

Employs advanced regression techniques, including Logistic, Poisson, and Zero-Inflated Poisson models, for robust quantitative analysis.

Likelihood Ratio Testing

Enhances signal validation using Likelihood Ratio Test (LRT) and Tree Scan Statistics (TSS) for deep analytical insights.

Real-Time Pattern Detection

Identifies increased frequency trends and patterns in data for proactive risk management and regulatory reporting.

Tree Scan Statistics

Explore hierarchical relationships in data for deeper, multi-level analysis.

DEEPER SAFETY INSIGHTS
Advanced Qualitative Analytics

Unlock comprehensive safety intelligence with qualitative analysis, focusing on patterns, populations, and real-world data for enhanced signal validation and proactive decision-making.

Comprehensive Signal Analytics Redefined

Unite qualitative insights, quantitative precision, and rich dashboards for unparalleled safety signal detection, validation, and regulatory compliance for drug, device and vaccine.

Holistic Signal Detection Approach
Our Signal Management platform combines qualitative and quantitative analytics to offer a 360-degree view of safety data. From analyzing global trends and event patterns to performing robust statistical evaluations, the platform ensures timely and accurate signal detection to safeguard patient safety.

Rich Dashboards for Actionable Insights
Transform complex safety data into visually intuitive dashboards. Use advanced filters, interactive visualizations, and dynamic reports to track compliance, workflow status, and signal life cycles. The Tree Scan Methodology enables multi-level hierarchical analysis, uncovering nuanced relationships in the data.

Workflow Management and Audit Trail 
Streamline the signal lifecycle with robust workflow automation. Assign tasks, track actions, and maintain a comprehensive audit trail to ensure transparency, compliance, and readiness for audits and inspections.

Transform Signal Management Today

Experience the power of our advanced Signal Management platform. Streamline workflows, ensure compliance, and enhance safety for drug, device and vaccine