Effortless Safety Case Management

Built specifically to support the E2B(R3) EudraVigilance system and MedDRA coding standards, SafetyEasy™ handles the reporting and management of all serious and non-serious adverse events. Its future-proof approach is able to generate PSUR, PBRER, and DSUR documentation and is ready for forth-coming standards such as IDMP. It also supports eMDR XML file creation. Through an EMA certified gateway, SafetyEasy™ provides you with a direct link to the regulatory authorities, eliminating the need for manual submission of reports.

SafetyEasy™ also enables you to readily track and monitor the status of workflows with every project in your organisation. Through email notifications and online dashboards, SafetyEasy™ provides users with reminders about imminent activities they need to perform. Now, you can ensure that your team members are staying productive and in the know. This guarantees submission deadlines are met, and other legal obligations are never overlooked again.

The CasEasy AI module leverages advanced Natural Language Processing (NLP) to streamline case creation. With CasEasy AI, imported or added ICSR verbatim text can automatically be converted into a case in SafetyEasy™, significantly reducing manual case creation times. It supports importing files in PDF, JPEG, and PNG formats, even handwritten documents if needed. This module also uses AI to suggest Adverse Events (MedDRA-coded) and flag potential serious cases.

Furthermore, the Business Intelligence module provides a 360° dynamic view of your scientific data, which enhances case analysis and improves the detection of safety signals. This powerful BI module is powered by Qlik Sense technology, which is also used by the US FDA and helps to boost your company’s efficiency and compliance. Compliance levels increase and reporting and KPI follow-up speed up.

The SafetyEasy™ Converter module is designed to save your team valuable time when entering cases into the system. By incorporating Optical Character Recognition (OCR), this AI-powered module automatically extracts and processes case information from uploaded forms, such as CIOMS, Medwatch, or SAE. The Converter not only reduces case intake time by up to 70% but also ensures that all required data is accurately captured and entered directly into SafetyEasy™.

The Literature Manager module optimizes surveillance by saving your team time on article screening. This comprehensive solution automatically connects to PubMed, helping you find, analyze, review, and create potential cases. The Literature Manager supports an unlimited number of products and uses advanced Artificial Intelligence to triage and sort only potential pharmacovigilance cases, significantly reducing screening volumes. Abstracts are processed through CasEasy AI, seamlessly creating cases in SafetyEasy™.

As a secure, cloud-based service, SafetyEasy™ is lightning quick to implement and requires no customization. In many instances, SafetyEasy™ can be configured and validated within two weeks. Its simple, intuitive, and user-friendly interface speeds user adoption and eliminates the need for extensive training. It is a complete, out-of-the-box solution for health science organisations of any size, location and speciality.

Used by more than 300 organizations across 90 countries, SafetyEasy™ is the simplest and most cost-effective way to ensure effortless compliance with current and future drug safety regulations. With ICH, EMA, FDA, EU GMP Annex 11, US FDA 21 CFR part 11, and EMA’s Good Pharmacovigilance Practice (GVP) guidelines, SafetyEasy™ is compliant with many regulations and directives from around the world.

iTAP is a fast, efficient solution created to help you with the triage and assessment of your ICSRs in the E2B(R3) format with customizable filters. L2A and/or MLM cases are retrieved from the Eudravigilance database and assessed enabling you to select relevant cases for your product portfolio. Every decision for each ICSR you make is tracked by iTAP so you can upload relevant E2B xml files with SafetyEasy™ directly to your database quickly and easily.