Special Section: Pharmacovigilance
scientist pointing to graphics of scientific icons
Six Key Considerations to Scale Pharmacovigilance with Modern Technologies
Saba Darvesh
Veeva Systems

ore than 16 million adverse events have been reported to the FDA over the last 10 years, nearly four times the volume from the prior decade. This growth is driving industry-wide action to improve intake and case processing. Many companies are scaling operations and increasing efficiency with modern tools for more strategic product development. This presents both opportunities and challenges and requires fresh thinking and more nimble processes.

To start the journey toward scalable and efficient safety operations, take a holistic approach that includes current and future business requirements. This can help address challenges upfront and reduce long-term risk. In addition, mapping out processes and identifying key stakeholders ensures alignment within and across teams. Once these foundational steps are complete and it is time to evaluate technology, prioritize these six key considerations to inform safety modernization efforts.

Simplify the Safety Systems Landscape

Fragmented systems and processes at each stage in the case processing lifecycle, and growing volumes of data, make it difficult to get an end-to-end picture of adverse events and related information. As a result, significant resources are dedicated to developing and maintaining integrations and manually moving or copying data and content between systems (Figure 1).
diagram illustrating the pharmacovigilance landscape today

Figure 1: What does the pharmacovigilance landscape look like today? Many systems require manual intervention. (Source: Veeva Systems)

Companies can enable seamless information sharing, reduce manual processes, and gain one source of safety data and content with a modern pharmacovigilance application built on a single platform. This enables seamless connectivity to systems in other functional areas and brings together case intake and processing, reporting, ICSR submissions, and analytics for end-to-end safety management and better signal detection (Figure 2).
a unified safety solution diagram from Veeva Systems

Figure 2: With key pharmacovigilance processes like case intake, case processing, and submissions in one solution, it is much easier to track and complete activities, process adverse events, and analyze data for potential signals. (Source: Veeva Systems)

Make It Easy to Keep Software Current

Biotechnology companies with lean IT teams often rely on outdated legacy systems because upgrades are costly and resource intensive. The next best alternative is to outsource the safety database to a contract research organization (CRO) or other service providers to maintain systems and meet growing regulatory requirements.

Cloud applications enable easy upgrades and access to new capabilities through automatic and pre-validated updates. With releases scheduled several times a year, the latest capabilities are clicks away.

To reduce the system validation burden, one should evaluate vendors that perform and document all elements of infrastructure qualification (IQ) and operational qualification (OQ) for each major version. Seamless upgrades and pre-validated systems allow pharmacovigilance teams to focus on high-value activities while maintaining compliance.

Configure, Don’t Code

Customizing applications to align with regulatory requirements takes a significant amount of time and effort, and many companies often delay making necessary changes. Over time, the gap between what the business needs and what the application delivers keeps getting wider.

Modern solutions provide the agility to create and modify business workflows with configuration, not coding. The efficiency gains reduce the administrative burden and enable greater productivity.

Think of the End User

A critically important but often overlooked area when evaluating new tools is the ease of use. Applications that offer an intuitive experience can increase user adoption and efficiency and require less upfront training.

Users should be able to effortlessly navigate through the application to find information and complete tasks. Administrators also need flexibility to support the business, with requirements like modifying security settings and changing data fields or workflows, quickly and easily.

Enable Real-time Outsourcing

Outsourcing the safety database to CROs or service providers can improve safety management and deliver cost efficiencies. But challenges with data access and pharmacovigilance oversight limit visibility and reduce control over safety processes.

“Anytime, anywhere” oversight and the ability to deliver dashboards and reports are key in an outsourced pharmacovigilance model. Sponsors should be able to access their data with real-time visibility into safety information and operational efficiency. This drives confidence that all new adverse events are captured, cases are processed on time, and challenges can be identified proactively.

Connect Data and Processes Across Functions

Lack of connection between safety and other areas like quality, clinical, or regulatory leads to the use of manual processes to share information. This increases the risk of error and is not a scalable way to work across functions.

Solutions built on a single platform facilitate automation and access, making it easier to exchange data across teams. Seamless, cross-functional workflows minimize manual tasks such as data queries and re-entering of clinical data into safety applications. They also eliminate tedious processes like the reconciliation of serious adverse events (SAE), and quality systems capture PQCs (product quality complaints) with nonadverse events (NAEs). Companies are benefitting from this approach because it delivers a stronger data foundation across the company and increases transparency for more informed decision-making (Figure 3).

a visual diagram illustrating key pharmacovigilance processes

Figure 3: Connecting safety operations with functional areas across product development enables seamless information exchange and speeds execution of key pharmacovigilance processes like adverse event and queries reporting. (Source: Veeva Systems)

Plan for Growth

The evolution from clinical stage to product commercialization requires global drug surveillance in multiple markets and regions. Biotechnology companies and other fast-growing companies need solutions that can scale with this growth while simplifying system management. Cloud-based applications include hardware, storage, and disaster recovery and are continuously monitored, ensuring expected performance.

To simplify global submissions across different regions, look for solutions with built-in gateways, including FDA, EMA, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), Health Canada, China National Medical Products Administration (NMPA), and Japan Pharmaceuticals and Medical Devices Agency (PMDA). This will make it easier to enter new markets through seamless reporting of adverse events to global regulators.

Drive Connected Pharmacovigilance

Safety leaders are using innovative technologies to keep up with evolving regulations, improve collaboration across functions, and quickly expand into new global markets while meeting regional requirements. But to achieve cost and process efficiencies, companies must identify the right solution that meets their current and future safety operational needs. (See Steps for Planning Pharmacovigilance Transformation.)
Steps for Planning Pharmacovigilance Transformation
Biopharmaceutical companies, large or small, can benefit from multitenant cloud pharmacovigilance solutions. By considering what the ideal system for your organization looks like, involving key stakeholders, and moving beyond stand-alone solutions, organizations can drive end-to-end safety processes. With less time spent manually processing cases and data, the industry can improve signal detection and drive a greater focus on patients.