Safety & Pharmacovigilance

The Safety & Pharmacovigilance solution is a cloud-based platform built on Salesforce, designed to provide a comprehensive view across R&D and commercial operations. It aids pharmaceutical, biotech, and medical device companies in making informed safety decisions by optimizing global pharmacovigilance compliance and integrating regulatory features seamlessly.

This solution centralizes data on a cloud platform, facilitating advanced analytics and ensuring data integrity. It supports proactive pharmacovigilance with smart features that enhance predictability, scalability, and cost-effectiveness.

Cloudbyz offers a robust pharmacovigilance system that simplifies processes, improves efficiency, and delivers actionable insights. It enables efficient collection, analysis, monitoring, and prevention of adverse drug effects by unifying data from various sources into a single hub.

Key Features

• Automated Case Intake: Utilizes advanced technologies to automate case intake from multiple sources and formats, enhancing management efficiency and accuracy.
• Configurable Case Workflow Automation: Standardizes tasks from intake to follow-up, reducing manual errors and increasing efficiency.
• WHO DD/ MedDRA Medical Coding: Integrates WHODrug and MedDRA dictionaries for standardized coding of medical data, supporting both library-based and API-based approaches.
• Submission Preview: Allows users to preview regulatory reports in draft or final form before submission.
• Case Extraction from Unstructured Documents: Employs AI to extract data from unstructured CIOMS documents, improving accuracy and speed.
• Template-Based Automatic Narratives: Generates uniform case narratives using predefined templates for consistency and ease of analysis.
• Medical Review and Approval Automation: Automates workflows and alerts for swift and accurate medical reviews and approvals.
• AI/ML Data Extraction & Redaction: Features AI/ML capabilities for data extraction and redaction from unstructured documents.
• Regulatory Submission E2B Gateway: Facilitates seamless report submissions to global health authorities in various required formats.
• Aggregate Reporting: Processes cumulative safety data for regulatory submissions, generating reports like PSUR, PADER, and more.
• Risk Management: Provides tools for assessing and managing potential risks associated with products.