Xolomon has created an online platform for pharmacovigilance management. Our solution complies with ICH E2BR3 and FDA CFR 21 Part 11. Xolomon Pharmacovigilance is based on our technological platform, validated and widely used in the management of clinical data. In addition to case management, Xolomon incorporates tools for importing cases in R2 format, as well as electronic notification via the Gateway provided by Eudravigilance. Xolomon also has a powerful reporting system that allows you to generate templates for the usual report formats such as CIOMs or DSUR, and also custom templates for each organization. Our product has a specific module for the management of adverse effects produced in clinical trials and is integrated with our EDC/eCRF solution.

BENEFITS

Agile and dynamic

  • Xolomon offers a high level of customization in the pharmacovigilances platform
  • With Xolomon, making changes to the final system is very fast and easy

Security

  • All information is encrypted before transmission or storage
  • Xolomon is hosted in the cloud using Windows Azure
  • Customizable user roles combined with user groups offer a powerful security model to control access to the application
  • Xolomon complies with the General Data Protection Regulation (GDPR) and with the FDA 21 part 11 standard

Powerful and robust

  • Xolomon is based on Microsoft technology
  • Xolomon implements a powerful system of traceability with an audit trail, which makes it possible to collect data with the highest quality
  • In addition to collecting the cases, Xolomon offers the possibility to create customized reports to track the evolution of the cases

Streamlining and cost savings

  • The rapid development and centralization and automation of tasks, makes Xolomon offer significant cost savings
  • Since it is offered as SaaS (Software as a service), it is not necessary to install software or invest in servers
  • Xolomon offers various flexible licensing options

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