SafetyEasy PV - E2B R3 Pharmacovigilance Management Software

The most cost-effective solution for effortless E2B(R3) drug safety compliance

Understanding the risks and benefits associated with pharmaceutical products brings with it the need for more efficient and effective pharmacovigilance solutions. Ensuring this clear picture protects both patients and manufacturers against unnecessary risks and ensures regulatory compliance.

Maintaining pharmacovigilance data is a mandatory regulatory requirement. Yet despite the undoubted benefits it brings, it can be a highly time intensive and costly process that ultimately contributes little to bottom line revenue. As such, the need to minimize these costs, yet deliver a best practice monitoring and reporting workflow is crucial to your business success.

EXTEDO’s SafetyEasy™ PV offering is a comprehensive and cost-effective solution designed to streamline your pharmacovigilance processes. It enables you to classify, create, review, submit and maintain pharmacovigilance data and adverse event reports within a single, easy-to-use application.

Benefits

  • Ensure compliance
  • Readily monitor safety activities and track submission deadlines
  • Compliant with latest E2B(R3) and future drug safety regulations
  • Reduce costs
  • Single database for pharmacovigilance data
  • Cloud-based platform with no need for customization
  • Easy-to-use with minimal training effort
  • Increase efficiency
  • E2B gateway solution
  • Bi-directional data exchange
Intuitive data entry mask

Ensuring compliance with E2B(R3) drug safety regulations

Built specifically to support the E2B(R3) EudraVigilance system and MedDRA coding standards, SafetyEasy™ PV 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.

Through a EMA certified gateway, SafetyEasy™ PV provides you with a direct link to the regulatory authorities, eliminating the need for manual submission of reports.
In addition, SafetyEasy™ PV also enables you to readily track and monitor the status of workflows. Through email notifications and online dashboards SafetyEasy™ PV provides users with reminders about imminent activities they need to perform. This helps ensure that submission deadlines are met, and other legal obligations are not overlooked. 

Cloud-based pharmacovigilance service

As a secure, cloud-based service, SafetyEasy™ PV is lightning quick to implement and requires no customization. In many instances, SafetyEasy™ PV 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.

Used by more than 300 organizations across 90 countries SafetyEasy™ PV is the simplest and most cost-effective way to ensure effortless compliance with current and future drug safety regulations.SafetyEasy™ PV is compliant with the following regulatory guidelines: 

  • ICH, EMA and FDA regulations and directives related to reporting of an adverse event
  • EU GMP Annex 11
  • US FDA 21 CFR part 11
  • EMA’s Good Pharmacovigilance Practice (GVP) guidelines

     

Downloads

SafetyEasy PV Product Information

E2B(R3) - Challenges and Opportunities

Cloud Computing for the Life Sciences Industry

Pharmacovigilance Services

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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Technical Consulting

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.

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Education & Training Services

To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.

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