Customer Overview
A US-based, fast-growing, research-oriented multinational pharmaceutical company with a portfolio of over 100 products distributed globally. The company regularly submits safety cases to global pharmacovigilance (PV) authorities, including the EMA, MHRA, USFDA, and Health Canada.
Business Challenge
The client was using ArisG for pharmacovigilance operations but faced challenges with scalability and data management due to their rapid growth and increasing case volumes. They needed a modern, cloudbased safety system capable of handling end-to-end case processing and regulatory submissions efficiently across spontaneous, clinical trial, and medical device reports.
Clinevo Solution
The client chose Clinevo Safety for its comprehensive capabilities in case processing, management, and regulatory submissions. Clinevo implemented a non-E2B, XML-based data migration approach to seamlessly migrate historical safety data from ArisG into the Clinevo Safety cloud platform
Key highlights of the migration process:
- XML-based methodology ensured structured, accurate data transfer
- Smooth migration of all legacy data without data loss or downtime.
- Clinevo handled migration, validation, and testing end-to-end.
Results & Impact
- Seamless migration of historical data from ArisG to Clinevo Safety.
- Enabled the client to perform end-to-end safety case management and submissions to global authorities (USFDA, EMA, MHRA, HC, RoW).
- More than 3,000 cases processed annually using the Clinevo Safety platform
- Improved efficiency in managing Spontaneous, Clinical Trial, and Medical Device safety cases.
Conclusion
Clinevo's expertise in safety data migration and its robust Safety platform enabled the client to enhance pharmacovigilance operations, improve compliance, and scale their global submissions effectively.
For further information contact us at info@clinevotech.com
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