Clinical trials can last six to seven years or more from start to finish; Along the way, pharmaceutical companies can build strong and close relationships with their contract research organizations (CROs). However, as they move from a regulatory reporting relationship to post-approval safety oversight, the needs may change.
Finding a research partner with the pharmacovigilance (PV) capabilities to take a project to the next stage can be difficult. Outsourcing-Pharma discussed the topic with two executives, who offer advice and describe the benefits of finding a competent and suitable company:
- Nina Patel Lahanis, Associate Vice President of Security Sciences, Eversana
- Emmanuel Belabe, Associate Vice President of Security Product Management, ArisGlobal
OSP: Could you please talk about some of the ways pharmaceutical companies approach PV have evolved / changed in recent years?
NPL: As new technologies, including artificial intelligence, flood the market, it highlights the global need to adapt the pharmacovigilance practices of the pharmaceutical industry to both emerging and large-scale companies. . Performing superior pharmacovigilance practices from clinical trials throughout the product lifecycle becomes more and more complicated with changing regulations. This increases the overall costs of maintaining compliance, which is a key factor why 60% of manufacturers decide not to independently manage their pharmacovigilance needs and extensive safety data.
OSP: You notice that almost half of pharmaceutical 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 company is attractive, and how it could benefit them?
NPL: Manufacturers develop a long-standing relationship with CROs during their clinical development phase, as this can take several years. The CRO has learned about the safety profile of the product and the costs and quality are familiar to the pharmaceutical company.
Yes, it is definitely tempting to stick with the CRO when entering the next phase of the product lifecycle. Challenge your comfort zone to make sure this is the optimal PV solution.
OSP: In what ways could sticking with the same guys they started with lead to problems?
NPL: CRO security teams are based on clinical study projects with a beginning and an end. Post-market safety continues until the product is no longer on the market.
Additionally, there are many other PV requirements in place during post-market, in addition to SAE reporting, which is the primary role of the CRO security team. Because of this, many CROs do not have the expertise in-house, resulting in a potential loss of valuable data information.
OSP: What advice do you have for selecting a CRO capable of effectively managing PV needs at each phase? What qualities and abilities should be on your checklist?
NPL: Evaluate your supplier so that they can be with you for the long term and truly understand VP in clinical and post-market areas with in-house expertise in all activities as per regulatory requirements. Set goals for true management of the security profile of your asset and how they will evolve throughout your product lifecycle. Don’t settle for it; take the time to assess the longevity of your CRO partner.
OSP: How should pharmaceutical companies and their research partners best manage PV data?
EB: PV data is complex, large and requires flawless data management. To simplify the sometimes daunting task of managing PV data, find a partner that provides an advanced technology platform that can consolidate and integrate all of your security data into a centralized system.
As part of your partner selection process, ensure that your partner company can migrate regulatory reporting to post-market safety data in the new data management system and that this partner has a vision and plan that will integrate your security data into the largest data pool. within your organization. Collectively, this data will serve as the data fabric that will allow your team to unearth insights using previously siled information.
OSP: Can process automation help streamline and automate PV? Please share your thoughts on this.
EB: The automation provided by artificial intelligence (AI), machine learning (ML), and rule-based process automation (RPA) is essential to modern PV. AI and ML can analyze large volumes of PV data, reduce tedious and mundane processing, and provide automatic event and product coding. Automation is expected to lead to case processing requiring less manual effort, leading to lower costs and less inconsistency in case data and the assessment of that case data.
The standardization of the process mainly leads to this efficiency. Whether RPA or cognitive, the system operates within a defined framework that is the same day today. Although the logic of the system may need to be improved, errors are not attributable to human error.
Once a process is standardized, volume changes are easier to manage and the process can continue to improve by identifying gaps or challenges. When introducing an automation strategy, companies should re-evaluate the processes targeted for automation and avoid automating outdated processes that overcome outdated challenges.
By streamlining these PV processes, automation will reduce low-value work and free up teams to work on forward-thinking initiatives, further increasing the ROI achieved.
OSP: Do you have anything else to add?
EV: Invest time to check PV partners to make sure you choose one that combines robust technology with PV experience and expertise. Choosing a partner with an ideal combination of technological and photovoltaic know-how will allow you to succeed in this demanding and complex stage of the product lifecycle.