Pharmacovigilance
Xolomon has created an online platform for pharmacovigilance management. The solution is based on ICH E2BR3 and FDA CFR 21 Part 11. Xolomon Pharmacovigilance is based on our validated and widely used technology platform for clinical data management.
Xolomon has a powerful reporting system that allows the generation of templates for common reporting formats such as CIOMs or DSURs, as well as customised templates for each organisation.
Our solution has a specific module for the management of adverse events in clinical trials and integrates with our eCRDs solution.
Xolomon Pharmacovigilance using the latest version of MedDRA
Data import format in R3 format
Specific module for adverse event management in clinical trials
Automated notifications
Creation of customised portals for the organisation or study
With Xolomon, it is very easy and quick to make changes to the pharmacovigilance platform
Pharmacovigilance Xolomon features a fast and intuitive web interface
All information is transmitted and stored encrypted with access via HTTPS and SSL communications.
Daily backups
All contributed and generated documentation is stored in the cloud
Xolomon is hosted in the cloud, in Microsoft Azure
Customisable user roles that, together with user groups, provide a powerful security model for controlling access to the application
Xolomon complies with European GDPR, EMA, and FDA 21 part 11 regulations
Xolomon is based on Microsoft technology
Xolomon implements a powerful traceability system using Audit trail, which allows data collection with the highest quality
Export of data in the main formats for further statistical exploitation
Pharmacovigilance Xolomon generates CIOMs and DSUR reports
Generation of reports and dashboards for real-time monitoring with the possibility of easy export from the same platform
The speed of development means that Xolomon offers significant cost savings
As it is SaaS (Software as a Service), there is no need to install software or invest in servers
Xolomon offers a variety of flexible licensing models
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