SafetyEasy

SafetyEasy, developed by EXTEDO in partnership with AB Cube, is a cloud-based pharmacovigilance and multivigilance management platform designed to support compliance with drug safety regulations including E2B(R3) and HL7 eMDR. It is intended for health science organisations of any size, location, and speciality, covering pharmacovigilance, medical device vigilance, cosmetovigilance, and nutrivigilance within a single database. The platform is used by more than 300 organisations across 90 countries.

SafetyEasy addresses common challenges in safety case management, including growing case volumes, tracking follow-up activities, meeting ICSR reporting timelines, handling multiple report types, managing clinical trial cases, and performing signal detection. It operates as a software-as-a-service (SaaS) solution that can typically be configured and validated within two weeks, requiring no customisation and minimal training.

Regulatory Compliance

• Built to support the E2B(R3) EudraVigilance system and MedDRA coding standards for reporting and managing serious and non-serious adverse events.
• Supports generation of PSUR, PBRER, and DSUR documentation and is designed to accommodate forthcoming standards such as IDMP.
• Supports eMDR XML file creation for medical device vigilance reporting.
• Connects directly to regulatory authorities via an EMA-certified gateway, removing the need for manual report submission.
• Compliant with ICH, EMA, FDA, EU GMP Annex 11, US FDA 21 CFR Part 11, and EMA Good Pharmacovigilance Practice (GVP) guidelines.
• Includes a Custom Anonymization Management function allowing users to customise anonymisation settings for XML E2B (R2 and R3), CIOMS, and MedWatch output formats to address GDPR requirements across different countries.

Workflow and Productivity Features

• Tracks and monitors the status of workflows across all projects within an organisation.
• Provides email notifications and online dashboards to alert users to upcoming activities and submission deadlines.
• Offers bi-directional data exchange capabilities and an E2B gateway solution.
• Supports API connections for data and functionality integration with other systems.

AI-Powered Modules

• CasEasy AI: Uses Natural Language Processing (NLP) to automatically convert imported or manually added ICSR verbatim text into a case record. Supports PDF, JPEG, and PNG file formats, including handwritten documents. Suggests MedDRA-coded Adverse Events and flags potentially serious cases, reducing manual case creation time.
• SafetyEasy Converter: Uses Optical Character Recognition (OCR) to automatically extract and process case information from uploaded forms such as CIOMS, MedWatch, or SAE reports. Reported to reduce case intake time by up to 70%.
• Literature Manager: Automatically connects to PubMed to support article screening, analysis, review, and case creation. Uses AI to triage and sort potential pharmacovigilance cases from literature, supports an unlimited number of products, and processes abstracts through CasEasy AI to create cases directly in SafetyEasy.

Business Intelligence Module

• Provides a dynamic 360° view of scientific safety data to support case analysis and safety signal detection.
• Powered by Qlik Sense technology, the same platform used by the US FDA.
• Supports KPI follow-up and compliance reporting.

iTAP — ICSR Triage and Assessment

• Supports triage and assessment of ICSRs in E2B(R3) format with customisable filters.
• Retrieves L2A and/or MLM cases from the EudraVigilance database for assessment against a user's product portfolio.
• Tracks every decision made for each ICSR and allows direct upload of relevant E2B XML files into SafetyEasy.

Getting Started — Typical Onboarding Steps

1. Book a demo with EXTEDO experts to review how SafetyEasy handles safety case management.
2. Discuss existing safety processes and outline an approach to simplify case management.
3. Configure and deploy SafetyEasy, typically within two weeks, with no customisation required.

Available Services

• Pharmacovigilance Business Process Consulting: Identifies gaps in pharmacovigilance processes and supports development and implementation of appropriate strategies, including PSMF.
• Education and Training: Tailored training sessions covering technical and regulatory topics, delivered in-house or onsite.
• Technical Consulting: Supports correct installation, implementation, and integration of the SafetyEasy solution.

SafetyEasy is deployed as a secure cloud-based service and is positioned as an out-of-the-box solution suitable for organisations across the health sciences sector. EXTEDO also provides validation services and extended support services to complement the platform deployment.