The CloudByz RMP (Risk Management Plan) feature is an integral component of the CloudByz Safety & Pharmacovigilance (PV) Solution, which is a cloud-based platform built natively on Salesforce. The solution is designed for pharmaceutical, biotech, and medical device companies, as well as CROs and clinical investigators, to optimize global pharmacovigilance compliance and enhance patient safety.
Product Overview and Key Benefits CloudByz Safety & PV provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, regulatory reporting, signal detection, and risk management. Built on the Salesforce platform, it offers a 360-degree view across R&D and commercial operations, ensuring data integrity, scalability, and regulatory compliance.
Main Features and Capabilities
- Risk Management: Proactive assessment and management of potential risks associated with products, enabling swift action on identified risks.
- Automated Case Intake: Streamlines case intake from various sources and formats, including ICH E2B R2/R3, leveraging AI/ML for data extraction and redaction.
- Regulatory Reporting & Submissions: Facilitates seamless submission of reports to global health authorities in required formats (E2B R2/R3, MedWatch 3500A, MDCG).
- Signal Management: Assists medical experts in signal detection using statistical approaches and predefined customizable algorithms.
- Medical Coding: Leverages WHODrug and MedDRA dictionary integrations for coding adverse events and medications as per industry standards.
- Workflow Automation: Configurable automated workflows standardize tasks from intake to follow-up, reducing manual errors.
- Real-Time Analytics: Interactive reports and dashboards provide real-time insights for C-suite executives and end-users.
Target Users and Use Cases The software targets pharmacovigilance teams, drug safety officers, clinical research organizations (CROs), and sponsors in the life sciences and healthcare industries. Primary use cases include maintaining global PV compliance, executing Risk Management Plans, efficient adverse event processing, and comprehensive drug/device safety monitoring.