Safety & Pharmacovigilance

Cloudbyz Safety & Pharmacovigilance is a cloud-based solution built natively on the Salesforce platform, designed to streamline drug safety operations and ensure global regulatory compliance. It empowers pharmaceutical, biotech, and medical device companies to manage adverse events efficiently, improve patient safety, and make faster, data-driven decisions. The platform supports the entire pharmacovigilance lifecycle, from case intake to regulatory reporting, with intelligent automation and advanced analytics.

Features

• Automated Case Intake: Supports multi-source intake using formats like ICH E2B R2/R3, improving efficiency and accuracy.
• Configurable Case Workflow Automation: Standardizes and automates case processing from intake to follow-up.
• Medical Coding: Integrates WHO DD and MedDRA dictionaries for standardized coding of adverse events and medical data.
• Submission Preview: Allows users to preview and export regulatory reports in draft or final form.
• Case Extraction from Unstructured Documents: Uses AI to extract data from CIOMS forms and other unstructured sources.
• Template-Based Narratives: Automatically generates case narratives using predefined templates.
• Medical Review and Approval Automation: Streamlines review processes with alerts and automated workflows.
• AI/ML Data Extraction & Redaction: Enhances data handling with intelligent automation.
• Regulatory Submission Gateway: Supports E2B R2/R3, MedWatch, and other global formats.
• Aggregate Reporting: Generates PSUR, PADER, PBRER, DSUR, and ad-hoc reports with auto-generated templates.
• Signal Management: Detects, validates, and prioritizes safety signals using statistical methods and customizable algorithms.
• Risk Management: Assesses and mitigates product-related risks proactively.

Capabilities

• End-to-End Lifecycle Management: Covers all pharmacovigilance activities from intake to reporting.
• Centralized Data Hub: Acts as a single source of truth for adverse event data and regulatory documentation.
• Real-Time Analytics: Provides insights into safety trends and risks using machine learning.
• Regulatory Compliance: Ensures adherence to global standards with automated reporting and audit trails.
• Customizable Workflows: Adapts to organization-specific processes and SOPs.
• Seamless Integration: Connects with CTMS, EDC, EHRs, and external regulatory databases.
• Collaborative Platform: Enables secure, real-time collaboration across teams and geographies.
• Scalability: Supports organizations of all sizes with flexible deployment and configuration options.

Benefits

• Enhances patient safety through proactive risk and signal management.
• Improves operational efficiency with automation and centralized workflows.
• Reduces manual errors and accelerates case processing.
• Ensures global regulatory compliance and inspection readiness.
• Provides accurate, real-time data for informed decision-making.
• Supports agile response to market and regulatory changes.
• Optimizes resource allocation by automating repetitive tasks.
• Scales with organizational growth and evolving pharmacovigilance needs.