Safety & Pharmacovigilance

Cloudbyz Safety and Pharmacovigilance (PV) is a cloud-based solution built natively on the Salesforce platform, designed to help pharmaceutical, biotech, and medical device companies improve patient safety, optimize global regulatory compliance, and make faster, better-informed safety decisions. By centralizing data across R&D and commercial operations, the platform provides a 360-degree view of drug safety activities and supports end-to-end pharmacovigilance management.

The solution integrates data from multiple sources into a unified, cloud-based hub, enabling advanced analytics, data integrity, and proactive pharmacovigilance. It is built to be scalable, cost-effective, and easily integrated with existing regulatory compliance workflows, making it suitable for organizations of all sizes operating in a rapidly evolving life sciences landscape.

Key Features

• Automated Case Intake: Automates the intake of cases received from various sources and formats, including ICH E2B R3 and R2, significantly increasing case management efficiency, scalability, and accuracy. Users can filter cases for regulatory submission review based on defined timelines.
• Configurable Case Workflow Automation: Provides configurable automated workflows that standardize tasks from intake through follow-up, reducing manual errors and freeing teams to focus on higher-priority activities.
• WHO DD / MedDRA Medical Coding: Integrates WHODrug and MedDRA dictionaries to enable coding of adverse events, medical histories, laboratory tests, and medications per industry standards. WHODrug can be integrated via API, eliminating the need for full dictionary uploads. MedDRA versioning can be managed per account, project, or clinical study, with support for both library-based and API-based coding.
• Submission Preview: Allows users to preview all cases within a desired regulatory report simultaneously, with the ability to view and export reports in draft or final form prior to submission.
• Case Extraction from Unstructured Documents (CIOMS): Uses advanced AI technology to extract critical case details from unstructured CIOMS documents, reducing manual effort and improving data accuracy and processing speed.
• Template-Based Automatic Narratives: Generates detailed case narratives using predefined templates, ensuring uniformity across all case reports and saving significant time during case documentation.
• Medical Review and Approval Automation: Automates medical review and approval workflows with alerts, enabling swift and accurate reviews and ensuring timely action on critical adverse events.
• AI/ML Data Extraction and Redaction: Provides AI/ML-based data extraction and redaction capabilities for unstructured documents, enhancing data processing efficiency and privacy compliance.
• Regulatory Submission E2B Gateway: Enables seamless submission of reports to global health authorities in E2B R2, E2B R3, MDCG, and MedWatch 3500A formats, ensuring compliance with international pharmacovigilance standards.
• Aggregate Reporting: Processes cumulative safety data from a wide range of sources on a periodic basis and supports regulatory submissions of PSUR, PADER, PBRER, DSUR, and ad-hoc reports. The system generates case line listings at MedDRA level for individual products using auto-generated templates aligned to client SOPs.
• Risk Management: Provides advanced tools to proactively assess and manage potential product risks, enabling swift action on identified risks to enhance patient safety and reduce potential harm.
• Signal Management: Assists medical experts in signal detection using well-defined statistical approaches with configurable Signal Disproportionate Report (SDR) thresholds, signal validation through customizable algorithms for case-by-case analysis, and signal prioritization based on defined criteria. Supports FAERS and EVDAS reviews by monitoring SDR and ROR metrics, and integrates with Litbyz for gathering additional supportive data for signal assessment.
• Integration Capabilities: Seamlessly integrates with external databases and systems to ensure efficient data exchange and a unified view of drug safety data, supporting more informed decision-making.
• Unified with Cloudbyz Clinical Trials Management: Integrates natively with Cloudbyz CTMS, eTMF, and EDC solutions on the Salesforce platform, creating a unified environment that supports end-to-end clinical and post-market processes.

Benefits

• Streamlined Operations: Centralizing and automating drug safety operations improves efficiency, reduces manual errors, and allows teams to focus on more critical, value-added work.
• Regulatory Compliance: Automated reporting and standardized coding ensure adherence to global pharmacovigilance regulations, reducing the risk of non-compliance penalties and supporting smooth interactions with regulatory bodies.
• Accurate Data: Real-time, reliable data promotes data integrity and consistency, enabling accurate safety assessments and proactive responses to potential issues.
• Early Detection: Advanced signal detection capabilities allow organizations to identify potential safety issues early, enabling prompt action and reducing the impact of adverse events.
• Enhanced Patient Safety: Efficient tracking and management of adverse events and drug-related risks directly contributes to improved patient safety outcomes.
• Better Resource Allocation: Automation of repetitive tasks frees staff to focus on strategic, higher-value activities, improving overall organizational productivity.
• Quick Response to Market Changes: Real-time data access and analysis features enable organizations to adapt swiftly to evolving market conditions and regulatory requirements.
• Scalability: The solution is designed to scale alongside organizational growth, ensuring continuous and seamless support for expanding drug safety management needs.
• Data-Driven Decisions: Robust reporting and analytics capabilities support more accurate, impactful decision-making and drive operational excellence.
• Cost Efficiency: Automating manual tasks and leveraging cloud infrastructure reduces operational costs and physical infrastructure requirements, enabling better allocation of resources.

Cloudbyz Safety and Pharmacovigilance is ISO 9001:2015 and ISO 27001:2022 certified, reflecting its commitment to quality management and information security. As a native Salesforce platform solution, it offers robust integration capabilities with both internal Cloudbyz products and external systems, making it a comprehensive and compliant choice for life sciences organizations managing global drug safety operations.