Introduction

The market for pharmacovigilance software in 2018 and beyond is one that is attempting to catch up to other verticals that have long been disrupted by the “death of software”. The barriers that were in place such as regulations with a moving target, drug safety’s role as a cost center only, and the difficulty of accessing data are breaking down. The result is that there are now choices in the pharmacovigilance software market that weren’t available just a few years ago with potential clients that are more willing than ever to look past the systems of record and focus resources on building a system of intelligence that will drive pharmacovigilance workflow for years to come. 

Vendors focused on data and analytics can shift the paradigm of pharmacovigilance software and allow the science of pharmacovigilance to advance at a rapid pace. Innovation will come with end users empowered to take advantage of disparate data sources through a modern user experience. New signal detection algorithms and new, more efficient workflow built on the cloud and infinitely scalable, will allow drug safety departments to provide actionable contributions to all areas of an organization.

Read more about the paradigm shift occurring in pharmacovigilance software in a recent article in PharmExec, Pharmacovigilance Software's "Salesforce" Moment.

Evolution of PV Software

The concept of the evolution of software from a “system of record”, to a “system of engagement”, to a “system of intelligence”, is important and has far reaching implications for pharmacovigilance software.

A system of record is a data management term for an information storage system. In other words, a database. In the PV world, this is the ICSR database and the software that is used to enter those cases into the database. A system of record is a cost center. Licensing, maintaining, and upgrading the database takes significant resources.

A system of engagement evolves beyond handling case processing and storage to providing the capability for end-users to engage with those data and engage with other end-users around those data. Signal management software allows for aggregate signal detection and the ability for users to take those data and organize them as they deem appropriate. Systems of engagement create efficiencies that lead to cost reductions.

A system of intelligence connects with other systems and data sources to produce actionable intelligence. This not only creates efficiency, but also revenue potential. The concept of PV generating revenue may seem foreign but can occur when the function serves not only its regulatory purpose, but contributes to commercial decisions. PV Analytics are a system of intelligence where end users take advantage of disparate data sources through a modern user experience.

Pharmacovigilance software evolving from a system of record to one of intelligence. Further analysis can be found in this recent RxView blog post, The Evolution of Pharmacovigilance Software

PV Software Trends

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.

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. 

In order to properly operationalize these data in for pharmacovigilance workflow, the silos need to be broken down. To do this the data must be: 1) characterized and the limitations understood; 2) linked together; and 3) presented in a way that makes them actionable.

Safety data can be categorized into three buckets: company owned, curated, and licensed data.

Company owned data include those captured in a clinical safety database or the data that are received from spontaneous post-marketing reporting and are stored in internal databases.

Vendor curated data include FDA Adverse Event Reporting System (FAERS), WHO’s Vigibase, and the various unstructured data that exist, such as clinical study results that are published in government registries like clinicaltrials.gov or found in publications, abstracts, and poster presentations.

Licensed data are those data assets that an organization licenses from different vendors. Examples of these data include multi-payer claims, EHR, and social listening. These sources vary widely in structure and use case and can often sit in different areas of the organization.

All of these data have different structures, different ontologies and different data dictionaries. These differences make forming linkages and relationships within the data difficult without an extensive data science effort and an intimate knowledge of all of the data. Even for those companies that could dedicate the budget and resources to this problem, those data would remain powerless without an equally large effort in developing an actionable user-interface.

Modern pharmacovigilance departments are demanding seamless connections between all of their disparate data corralled in next generation, commercial off-the-shelf platforms with an easy to use front end. And most importantly, they require the analyses of these drug safety data to be agile and flexible, while still maintaining analytical rigor.

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 and outsourcing has limitations. When outsourced contractors use large legacy software solutions, the restrictions on types of reports and limitations on how data can be viewed and manipulated can severely restrict how a pharmacovigilance department operates and supports the organization. 

When the weight of these restrictions become too much, the only choice has been for the pharmacovigilance department to turn to large legacy software solutions. But this choice has significant cost and implementation consequences that can more than offset the advantages.

Fortunately, off-the-shelf next generation technology is now available for pharmacovigilance departments. Scalable, flexible, and agile platform solutions can make key processes like signal detection, validation and management accessible and equally scalable to pharmacovigilance departments and services vendors of all sizes.

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.

However, achieving that goal is not easy.  With multiple platforms and tools contracted into various departments, simply knowing who holds the access for one of the numerous available data sources is hard to discover. When the data are finally obtained, complex and outdated user interfaces make the analysis tasks much more difficult than they should be.

Many legacy software providers are trying to combat this problem by adding data and analytics suites on top of traditional workflow tools. This is a classic square-peg-in-a-round-hole solution - a band-aide approach that has been insufficient and fails to address the core issue of expanded safety science tasks and responsibilities.

This development isn't surprising. Traditional software providers have products that require months-long implementation processes and multi-million-dollar investments. And with a highly regulated and workflow-dependent industry like pharmacovigilance, there are troves of standard operating procedures in place. With competing priorities and strained resources, the seemingly logical (read: easier) approach has been one of quick fixes. Analytic jammed in SOP here... new dataset jammed into an SOP there...

But it's quickly become clear to many drug safety professionals that "quick fixes" aren't working anymore. And, even worse, those supposedly quick fixes may actually be stifling true innovation in the industry. With modern software-as-a-service and agile approaches to development, it doesn't have to be this way. Forward thinking pharmacovigilance departments are realizing this and taking steps today to adapt and move their processes forward.

Complex data integrations and modern analytics can't sit on top of traditional workflow tools. In a data-first world, those workflow tools need to be built in and around the data and analytics that drive decision making. And, yes, those workflow tools still need to comply with GVP best practice and regulatory requirements, but they must also allow for the flexibility to continue to expand in the future.

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.

Advera Health's Evidex platform has been built, and continues to be enhanced, in partnership with our clients to solve the challenges of the modern pharmacovigilance department.

An agile, flexible approach to data, analytics, and workflow allows for quick implementations that can meet the scale of both large and small organizations.

Download a White Paper that discusses the trends in Pharmacovigilance Software and read the RxView blog post, What's Driving Pharmacovigilance Technology Acquisition?

Legacy vs. Next Gen

Legacy pharmacovigilance software providers in this market have products that require months long implementation processes and multi-million dollar investments. And with a highly regulated and workflow dependent industry like pharmacovigilance, there are troves of standard operating procedures in place. With competing priorities and strained resources, the seemingly logical (read: easier) approach has been one of quick fixes. Analytic jammed in SOP here... New dataset jammed into an SOP there...

It's quickly become clear to more and more drug safety professionals that "quick fixes" aren't working anymore. And, even worse, may be stifling true innovation in the industry. With modern software-as-a-service and agile approaches to development, it doesn't have to be this way. Forward thinking pharmacovigilance departments are realizing this and taking steps today to adapt and move their processes forward.

Complex data integrations and modern analytics can't sit on top of traditional workflow tools. In a data-first world, those workflow tools need to be built in and around the data and analytics that drive decision making. And, yes, those workflow tools still need to comply with GVP best practice and regulatory requirements, but they must also allow for the flexibility to continue to expand in the future.

Read more about legacy vs. next generation pharmacovigilance software in the RxView blog post, Can Modern Analytics be Forced Into Traditional PV Workflow Tools?

Talk to us.

See Advera Health's Evidex in action, get questions answered, or just talk drug safety with like minded pharmacovigilantes.