Best Practice #3 - BLOGLast week's blog post discussed the importance of taking control of your pharmacovigilance software. This week we discuss Best Practice #3: Using software to create a shared services model with your CRO.

Retaining some pharmacovigilance software in-house does not mean eliminating CRO involvement. In fact, CROs have an opportunity to further enrich sponsor partnerships by not only being a trusted resource, but by recommending the use of next generation, cloud-based software that empowers both the sponsor and CRO to take active roles in pharmacovigilance.

This approach works extremely well with workflow heavy tasks, like signal management, where there are specific requirements that need to be met with a variety of personnel involved. Because new software are cloud-based, authorized users from both a sponsor and an outsourced vendor can easily access the software, complete actions, and advance workflow from any modern internet browser.

For example, consider a situation where it is the CROs responsibility to initially adjudicate a safety case report for seriousness and expectedness, but the sponsor wants to maintain responsibility for determining causality. Historically, with on-premise, legacy software a shared model like this would create complicated SOPs and ultimately be unrealistic to implement. However, with modern, next generation signal management software the CRO can log their actions and then assign the next step in the process to the sponsor, who will be alerted in real-time. The sponsor can make their causality determination, document their reasoning, and then alert the CRO all within a single, seamless, audit ready signal management platform.

Want all of the best practices in one place? Download the white paper, Pharmacovigilance Best Practices for Clinical and Early Post-Approval Biopharma. 

Download NowOther 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

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

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.