In recent years, the rapid development of “big data analytics” has created a surge within pharmaceutical companies to leverage data from the entire value chain to drive actionable insights. Although other departments within pharmaceutical companies have long been focused on utilizing data driven insights, modern pharmacovigilance departments are just starting to fully incorporate a data-and-analytics-first approach to signal detection, validation, and management.

At Advera Health Analytics, our sole focus is on operationalizing pharmacovigilance analytics through the Evidex® platform. Based on conversations with our current and prospective customers, we’ve identified three overarching trends that are driving both process adoption, and technology acquisition.

Excerpts from our recent white paper, Trends in Pharmacovigilance Data, Analytics, and Workflow in 2018 are below. Download the full white paper to read more. Also see our Complete Guide to Pharmacovigilance Software. 

Trend 1: Pharmacovigilance departments want to use new data sources but are finding it hard to operationalize them all.

The use of new data sources have been constrained by limitations on how to implement novel methods without disrupting traditional signal detection, validation, and management work flow. Analyzing these data in siloes creates a “can’t see the forest for the trees” scenario where the isolated insights that may be generated only make it to a departmental slide deck, a conference abstract, or, at best, a journal publication rather than to a place of real operational benefit... Read more.

Trend 2: In a resource constrained environment, pharmacovigilance departments are trying to leverage technology to work smarter and act bigger.

Most pharmacovigilance departments are resource constrained. Whether it’s human capital, budget, or both, drug safety specialists within pharmaceutical companies are being asked to do a lot more with very little. In a resource constricted environment, organizations must work smarter to achieve near and long-term goals.

With little new off-the-shelf technology being introduced for pharmacovigilance departments, “working smarter” has meant creating in-house solutions using spreadsheets or outsourcing key processes. Maintaining an audit ready process with spreadsheets is not scalable... Read more.

Trend 3: In response to new data sources agile, flexible approaches to data, analytics, and workflow are in high demand

Modern pharmacovigilance departments today do more than process and review ICSRs. They are involved in the entire lifecycle of a drug, providing vital data points and analysis that inform everything from clinical trial design to commercial planning to post-market safety surveillance. In order to perform well, pharmacovigilance and safety science teams require access to an array of data and the analytics to make sense of those data. The insights gained from unique combinations of clinical and real-world data can drive signal detection, epidemiological research, and evidence generation, all of which support organization-wide decisions... Read more.

Summary: The next generation of drug safety data and analytics has arrived, but companies are dissatisfied with legacy-based options.

It is clear that there are more data than ever for pharmacovigilance departments to leverage in their signal detection, validation, and evaluation work flow. However, the legacy software being used by most organizations limits the insight that can be gained from these data. There is a growing wave of general discontent by pharmacovigilance departments with the status quo. Adding new technology to address the concerns of modern pharmacovigilance is a short-term priority.

Download white paper


Topics: Pharmacovigiance 2.0

Jim Davis

Written by Jim Davis

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