For Clinical and Early Post-Approval Biopharma
The idea of selecting, implementing, and deploying pharmacovigilance software is overwhelming for smaller companies. At larger pharma companies, teams of people, vendors, and consultants are dedicated to implement the software and keep it running. Smaller clinical and early post-approval stage biopharma companies have to make do with significantly fewer resources and they are understandably quick to look for outside help.
For certain aspects of pharmacovigilance, outsourcing makes sense. Outside technology consultants and CROs play a vital role in helping an organization grow. But when it comes to access to vital data, the division of labor, and the ability to maintain proper oversight on drug safety operations, even smaller biopharma companies need to consider “in-sourcing”.
The best practices in this White Paper will help to understand regulatory requirements, what elements should be kept in house, and how to best work with CROs.
A next generation pharmacovigilance workflow platform that allows an organization to track and resolve safety signals and inquiries.
Built within the Evidex framework, Evidex Signal Management provides audit ready tools that safety reviewers want to use
Fully integrated and automated signal detection from multiple data sources, powered by Evidex Data & Analytics provides a wholistic, modern approach to pharmacovigilance
Validated off-the-shelf configuration based on GVP Module IX offers fast, compliant, and lean implementation, while maintaining the flexibility to meet any organization's unique needs