Signal management

Signal management in Excel stifles innovation in pharmacovigilance

Do people really want to use Excel? Explore the different perspectives behind choosing SaaS or Excel.

Advera Health Analytics spent hundreds of hours in 2019 discussing signal management with leaders in pharmacovigilance. Most of the conversations are in-depth discussions of stats, workflow, and technical features and benefits. However, when combined together, we discovered some interesting takeaways for a bigger picture. One problem that has become clear is that the use of Excel for signal management and tracking safety issues stifles innovation in pharmacovigilance.

As a brief introduction for readers who may not be familiar, it is good pharmacovigilance practice (GVP) that the Marketing Authorization Holders (MAHs) of a medicine perform signal detection. security and keep track of all activities that take place in the investigation of a security issue. It is the responsibility of the MA holder to monitor and report emerging safety issues. More information can be found in Advera Health Complete Guide to GVP IX Module for Signal Management2.

Given the importance GVP places on signal management, all organizations should have a tracking system in place. The decision that organizations must make is how to implement this tracking system: with a suitable software as a service (SaaS) or a generic tool like Excel. In order to better understand the choices that pharmacovigilance leaders are making today, it is important to understand the different points of view.

Generally, opinions fall into three distinct categories.

Many pioneering pharmacovigilance leaders are implementing best practices as early as possible, such as signal management software suitable for use. They believe that internalizing this critical aspect of drug safety will add value to the organization and save them time and money in the future. They understand that signal management software reduces the organizational risk that Excel can introduce in regulatory audits, with lost or corrupted spreadsheets, and through a lack of systemic knowledge transfer. They develop the business case early and receive buy-in from management. They never touch Excel for tracking security issues. With a seamless, all-in-one SaaS solution, they leverage pre-built analytics to generate security insights that benefit the entire organization.

Much like Bucket 1, the pharmacovigilance leaders in this group believe in best practices using a SaaS approach for signal management. However, they either don’t know how to build the business case or have failed to get management buy-in at an early stage. They haven’t been able to properly present a business case that is strong enough to convince executives that pharmacovigilance is not just a cost center and that the future benefits will outweigh the costs in the short run. Instead, they create interim solutions using Excel and other generic tools. Their processes work, but most of their time is spent making them work. They scramble to just comply with regulations and the pain only increases as the business evolves.

Just like Bucket 2, pharmacovigilance leaders in Bucket 3 use solutions like Excel and other generic tools. They think these solutions are sufficient for now. Now may be the time to move on to an appropriate software solution, but it’s not now. The intentions of the leaders of this Bucket 3 are noble; they know their organization is on a tight budget, that they may have a relatively low number of security cases, or that their products may have a “really clean security profile”. They don’t even try to justify a software approach. Unfortunately, the leaders of this group do more harm than good in the long run. Resources devoted to maintaining their processes unnecessarily consume their time and that of their team members, especially as the business grows. Over time, they become unable to add value to other areas of the organization because they don’t have the right tools in place to generate information quickly. And, unfortunately, this approach only serves to perpetuate the perception that pharmacovigilance is just a cost center.

In an article previously published in Applied Clinical Trials in November 2018, Pharmacovigilance software at its moment Salesforce, we discussed how pharmacovigilance is finally catching up with other industries when it comes to adopting SaaS solutions. Cloud-based back-end infrastructure and modern user experiences are transforming the way information is generated and providing tools that security reviewers actually want to use.

Do people really want to use Excel? A recently published study1 on the usability of an adjacent industry shows that Excel scores a failing grade, just behind Electronic Health Records (EHRs). What may seem “manageable” or “good enough” now quickly turns into cumbersome processes with users burdened with complicated, nonspecific systems. And the longer an organization goes without a solution that meets its needs, the more and more resources it takes to move to a solution.

Next-generation SaaS signal management platforms exist to manage clinical and post-market safety case reports in a GVP Module IX compliant manner that can scale to any budget, in no way. any business of any size. They can be implemented early and easily and evolve in line with the marketing needs of the MAH over time.

Signal management software creates efficiencies and mitigates regulatory risks, even for the youngest companies. As the new decade approaches, business leaders and IT managers should prioritize the assessment, selection and implementation of this capability as early as possible in order to lay the foundation for organizational success in the years. future.

Jim davis is executive vice president of Advera Health Analytics, Inc.

  1. The association between the perceived usability of electronic health records and burnout among American physicians. Melnick, Edward R. et al. Proceedings of the Mayo Clinic, Volume 0, Number 0