Best Practices - BLOGThanks to everyone on the great feedback we have received on this blog series focused on pharmacovigilance best practices for clinical and early post-approval biopharma companies. We've discussed discussed the importance of understanding reporting and submission to FDA, taking control of your pharmacovigilance software and creating a shared services model with your CRO.

The simplicity that software brings to pharmacovigilance creates a shared services model that empowers the sponsor to maintain proper oversight of drug safety while enabling the CRO to implement the same model at scale. Next generation, cloud-based SaaS signal management platforms exist to manage both clinical and post-marketing safety case reports in a GVP IX compliant way that can fit into any budget, in any size company.

Signal management software creates efficiencies and mitigates regulatory risk. Both a sponsor organization’s business and IT leaders are encouraged to prioritize evaluation, selection, and implementation of this capability as early as possible to establish a foundation of organizational success.

Likewise, business and IT executives within CROs should look at next generation signal management, as well as signal detection software to drive a shared services model that will better support their clients’ needs, provide needed flexibility, and easily scale.

Other posts in the series: 

Introduction: Clinical and early post-approval stage companies have significantly few resources

Best Practice #1: Understand what is reportable and know how reports are submitted to FDA

Best Practice #2: Take control of your pharmacovigilance software

Best Practice #3: Use Software to create a shared services model with your CRO

Interested in signal detection? Read Pharmacovigilance Signal Detection: A Complete Guide

Interested in how software can help your organization stay ahead of FDA? Request a demo of Evidex a cloud based, software-as-a-service drug safety signal management platform that provides audit ready, GVP IX compliant signal tracking. Built with modern pharmacovigilance workflows in mind and fully integrated with all Evidex data and analytics, Evidex Signal Management is a next generation platform for managing signals from detection through resolution.


Topics: Drug Safety, FDA, Pharmacovigilance Software

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.