Within the life sciences industry, complex factors are shifting pharmacovigilance (PV) operations. Continuously evolving regulations, a wider range of data sources and a shortage of human expertise have created roadblocks within safety processes. To manage this added complexity, pharmaceutical organizations are shifting to advanced technologies for cost effective storage, processing and management of extensive PV data. 

In particular, outsourcing combined PV services and technology has become a critical way for organizations to balance cost, efficiency and compliance while still prioritizing the delivery of life-saving products. The PV market is expected to grow, particularly as the demand for outsourced PV services has an expected compound annual growth rate of 7% between 2023-2030. However, combined PV offerings are relatively new to the space. Recent research shows that while many life sciences organizations outsource their PV operations, 49% of pharma/biotech companies outsource to at least three vendors, and 11% outsource to five or more. As they look to consolidate, it is critical to identify the factors to consider, the barriers to implementation and the benefits of combined PV services and technology.

Setting the scene for drug development
In today’s landscape, regulatory bodies are bearing down on dose optimization and adverse drug reaction prevention practices. Alongside stricter regulations, global discrepancies and country-specific requirements can disrupt PV workflows if parameters are not differentiated adequately. 

Orphan drugs and other unique modalities within development has introduced even more complexity, and companies seek ways to minimize risk and cost. Furthermore, increased competition and pressure from regulatory authorities, health care providers and patients for real-world data and real-world evidence has led to an overall push for harmonized approaches to PV operations. 
Strategy is outsourced the most, followed by technology/database and compliance management. Companies are looking towards vendors to manage timelines and incorporate robust methods into their PV operations. 

Addressing barriers 
The PV landscape is convoluted, and while current trends show an eagerness to outsource combined PV services and technology, senior-level executives from emerging to large global pharma or biotech organizations have identified some barriers to integration.

Financial obstacles and miscommunication were noted as the key obstacles to outsourcing combined PV solutions. Research and development spending is on the rise as inflation rates remain high and the increasingly complex products require additional development costs. This has resulted in the common use of the multi-vendor strategy among larger, more mature organizations that are both looking to diversify spending and able to do so. As the outsourcing budget is typically separate from the company’s technology budget, the cost of combined PV solutions may also be misleading and deter leaders from exploring these offerings. 

In terms of miscommunication, established organizations may favor vendors they have longstanding relationships with. The risk for miscommunication with a vendor that has historically performed well with project management is low, which is why a one-vendor-fits-all situation is rare. It is key to note that while organizations build trust with their vendors in areas where they excel the most, only 16% of companies noted concerns with relying on a single vendor. 

Evaluating factors
According to the research, the most important factors when selecting PV technology are data security, cost and efficiency. As advanced automation such as artificial intelligence continues to integrate into the life sciences industry, there is hesitation around the potential risk in terms of reliance on technology rather than human expertise. However, automated end-to-end digital safety tools evolve alongside technology with more advanced data mining and signal detection tools. 

Though there are many, operational efficiency, reduced time-to-market and easier vendor management were listed as the top benefits of combined PV solutions. Organizations maximize efficiency through a shared platform visible to all stakeholders and sources, reducing the number of databases required and the time for constant regulatory updates. Most PV technology is designed to handle large case volumes, but not all can process cases across different languages. With a more complex or novel product, research and planning around the right PV solution is required.

Embracing the future of PV innovation
Innovation within PV operations will help determine the industry’s progress in the next few decades. It will take a collaborative effort between regulatory authorities and life sciences companies to clarify guidance and enhance communication to improve clinical trial outcomes, but the future is bright. 

The PV outsourcing market will continue to thrive as the global PV market is estimated to reach $11.8 billion by 2030, and combined PV solutions will become more widely adopted, particularly as 89% of organizations plan to adopt combined solutions in the future. The ways safety is measured and validated are shifting, and it is paramount that organizations remain vigilant regarding regulatory changes. The consolidation will bolster these changes so that safety within clinical development is as seamless and efficient as possible.