The most cost-effective drug safety database software for effortless E2B(R3) pharmacovigilance compliance, but also for medical device vigilance, cosmetovigilance and nutrivigilance.
Ensure compliance while increasing efficiency and reducing costs.
Readily monitor safety activities and track submission deadlines.
Assure data reliability and quality via business, technical and internal validation.
An easy-to-use, cloud-based platform requiring minimal training or customization.
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.
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.
SafetyEasy™ is a comprehensive solution designed to streamline your pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance processes. It enables you to classify, create, review, submit and maintain data and adverse event reports within a single, easy-to-use application.
The E2B(R3) EudraVigilance system and MedDRA coding standards forced organizations around the world to change the way they reported and managed adverse events. This brought with it new challenges, but also new opportunities.
Cloud computing is one of the most secure yet accessible solutions for life sciences. This new technology provides many opportunities for organizations that implement and use it correctly. Find out how in this whitepaper.
EXTEDO also offers Pharmacovigilance Business Process consulting services, which are tailored specifically to your needs. Based on many years of experience working with drug safety rules and regulations, EXTEDO´s team will help you to identify gaps in your pharmacovigilance processes and help you to develop and implement appropriate strategies PSMF to resolve them.
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To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.