Readily monitor safety activities and track submission deadlines
Assure data reliability and quality via business, technical and internal validation
Ensure compliance while increasing efficiency and reducing costs
Understanding the risks and benefits associated with pharmaceutical products, medical devices, cosmetics and food & dietary supplements, brings with it the need for more efficient and effective safety solutions.
SafetyEasy™ is designed to streamline your pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance processes quickly and effectively. Maintaining safety data is a mandatory regulatory requirement. Yet despite the undoubted benefits it brings, it can be a time-intensive and costly process that ultimately contributes little to bottom-line revenue.
SafetyEasy™ enables you to minimize costs, and deliver best-practice monitoring and reporting workflows crucial to your business success. Create, review, submit and maintain pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance data and event reports within a single, easy-to-use multivigilance application.
Request your personal EXTEDO Software Demo now!
Ensuring compliance with E2B(R3) and HL7 eMDR safety regulations
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.
Streamline workflows, optimize your productivity
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.
Cloud-based pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance software-as-a-service
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 worldwide for guaranteed compliance
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.
Triage and assessment of ICSRs in E2B(R3) with iTAP
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.
“The software makes the monitoring of safety data and
pharmacovigilance easier and more efficient. It saves time and increases efficiency in pharmacovigilance.”
Kate Chen, Business Development Specialist at T-TOP Clinical Research Co., Ltd.
Your plan to effortless compliance
Schedule a call
We’ll discuss your goals and uncover your challenges with your pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance compliance
Get a free consultation
Our experienced business and technical team will outline a solution to solve your challenges.
Manage your safety data effortlessly
Effortlessly manage your pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance data and event reports within a single, easy-to-use multivigilance application.
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.
Education & Training Services
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. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite.
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.