Clinical trials can take six to seven years or longer from start to finish; along the way, pharmaceutical firms can build strong, close relationships with their contract research organizations (CROs). However, as they move from a regulatory reporting relationship to post-approval safety surveillance, needs can change.
Finding a research partner with the pharmacovigilance (PV) capabilities to take a project to the next step can be challenging. Outsourcing-Pharma discussed the topic with two leaders, who offer advice and outline the benefits of finding a capable, fitting company:
- Nina Patel Lahanis, associate vice president of safety science, Eversana
- Emmanuel Belabe, associate vice president of safety product management, ArisGlobal
OSP: Could you please talk about some of the ways in which pharma firms approach PV have evolved/shifted in recent years?
NPL: As new technologies, including artificial intelligence, are flooding the market, this is spotlighting the global need to bring pharma’s pharmacovigilance practices up to speed across both emerging and large-scale companies. Executing superior pharmacovigilance practices from clinical trials throughout the product life cycle is becoming increasingly complicated with the changing regulations. This increases overall costs in maintaining compliance, which is a key factor as to why 60% of manufacturers decide against independently managing their pharmacovigilance needs and extensive safety data.
OSP: You note that close to half of pharma companies try to carry the CROs they use during R&D into the post-approval PV phase. Could you please share some of the reasons why staying with the same firm is appealing, and how it might benefit them?
NPL: Manufacturers develop a long-time relationship with CROsduring their clinical development phase as this can take several years to complete. The CRO has gained knowledge on the safety profile of the product and the costs and quality are familiar to the pharma company.
Yes, it is definitely tempting to remain with the CRO when entering the next phase of the product’s life cycle. Challenge your comfort zone to ensure it is the optimal PV solution.
OSP: What are some of the ways that sticking with the same guys they started with could lead to snags?
NPL: CRO safety teams are clinical study project-based with a start and an end. Postmarket safety is ongoing until the product is no longer on the market.
In addition, many other PV requirements are in place during postmarket in addition to SAE reporting which is the primary role of the CRO safety team. Because of that, many CROs do not have the expertise in house resulting in potential loss of valuable data insights
OSP: What advice do you have for selecting a CRO that can capably handle PV needs at every phase—what qualities and capabilities should be on your checklist?
NPL: Evaluate your provider so they can be with you long-term and truly understand PV across clinical and post-market with internal expertise across all activities per the regulatory requirements. Establish objectives for true safety profile management for your asset and how they will evolve throughout the lifecycle of your product. Don’t settle; take the time to evaluate your CRO partner for longevity.
OSP: How should pharma firms and their research partners best handle PV-related data?
EB: PV-related data is complex, voluminous, and requires flawless data management. To simplify the sometimes daunting task of PV data management, find a partner that provides an advanced technology platform capable of consolidating and integrating all of your safety data into one centralized system.
As part of your partner selection process, ensure that your partner company can migrate regulatory reporting to post-market safety data into the new data management system and that this partner has a vision and plan that will weave your safety data into the larger pool of data within your organization. Collectively, this data will serve as a data fabric that enables your team to make insights using previously siloed information.
OSP: Can automating processes help streamline and automate PV? Please share your thoughts on that.
EB: The automation provided by artificial intelligence (AI), machine learning (ML), and rules-based process automation (RPA) is essential to modern PV. AI and ML can analyze large volumes of PV data, cut down on mundane and time-consuming processing, and provide automatic event and product coding. Automation should lead to case processing that requires less manual effort, leading to lower costs and a drop in inconsistencies in case data and the assessment of that case data.
The standardization of the process primarily drives this efficiency. Whether RPA or cognitive, the system works within a defined framework that is the same day today. While the system logic may need improvement, the mistakes are not attributable to human error.
Once a process is standardized, changes in volume are easier to handle, and the process can continue to improve by identifying shortcomings or challenges. When introducing an automation strategy, firms should reassess the processes targeted for automation and avoid automating outdated processes that overcome obsolete challenges.
By streamlining these PV processes, automation will cut down on low-value work and free up teams to work on forward-thinking initiatives, further increasing the return on investment realized.
OSP: Do you have anything else to add?
EV: Invest time vetting PV partners to ensure you select one that couples robust technology with PV experience and expertise. Choosing a partner with an ideal pairing of tech and PV know-how will set you up for success in this demanding and complex stage of the product lifecycle.
