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 following best practices will help to understand regulatory requirements, what elements should be kept in house, and how to best work with CROs.
Best Practice #1
Understand what is reportable and know how reports are submitted to FDA
Best Practice #2
Take control of your software
Best Practice #3
Use software to create a shared services model with your CRO
Each of these best practices will be elaborated on in a series of blog posts released weekly.
Can't wait? Download the white paper, Pharmacovigilance Best Practices for Clinical and Early Post-Approval Biopharma.