In recent years, the pharmaceutical industry has grappled with multiple challenges, not least of which is the escalating cost associated with pharmacovigilance (PV). A mandatory element of pharmaceutical production, PV has become more demanding than ever due to factors such as increased regulatory requirements, necessitating more extensive PV activities; the growth in globalized PV, which requires coordinated collaboration to, for example, translate materials and meet local regulations; and the increasing complexity of medicines in terms of new mechanisms of action and new ways of delivery. All these elements, and more, have driven up the operational costs of PV. Consequently, many pharmaceutical companies outsourced PV tasks to overseas vendors to realize cost benefits of cheaper skilled labor. While initially appearing to be a cost-effective solution, the appeal of outsourcing PV abroad comes with its own challenges, particularly around the long-term sustainability and efficiency of such practices.
The long-term limitations of outsourcing
At first glance, outsourcing to countries where labor is less expensive represents a logical solution to tackle rising costs domestically. This trend plays across many sectors, most notably in electronics manufacturing. By tapping markets with lower labor costs, pharmaceutical companies have mitigated increasing PV costs, seeing notable reductions in operational expenses. However, the elasticity of demand dictates that economic development driven by increased outsourcing results in competition for skilled labor. Competition for a finite resource drives up labor and operational costs to the point where there is simply no more cost benefit from the manual supply chain. What was once a cost-effective option soon becomes another region with mounting operational expenses.
This cyclical pattern has created a phenomenon where companies are constantly in flux, moving operations from one country to another in a nomadic quest for the next cost-effective labor pool. Transitioning operations, training new teams and setting up infrastructure in a new region is disruptive and comes with a price tag that often negates the savings companies sought in the first place.
Beyond the financial implications, heavy reliance on outsourcing creates other risks and inefficiencies. Communication barriers, time zone differences and cultural nuances can lead to misunderstandings, delays and errors in critical PV tasks. The fragmentation of operations can result in a lack of cohesive oversight, potentially compromising the quality and consistency of PV reporting.
While outsourcing has provided a temporary respite from rising costs, the pharmaceutical industry is looking for ways to manage the point at which this strategy is no longer fully effective.
Intelligent automation breaks new ground
Intelligent automation (IA) combines artificial intelligence (AI) and automation technologies, heralding a new era of innovation for the pharmaceutical industry. Unlike traditional automation, which follows predefined rules and tasks, IA leverages machine learning (ML), natural language processing (NLP) and other advanced technologies to adapt, learn and make decisions, much like a human would. IA systems can sense and harmonize huge amounts of information to automate entire processes or workflows, continually learning and adapting to self-improve.
The intricate and multifaceted nature of PV, with its mixed data sets, rigorous reporting requirements and the need for timely analysis, makes it a prime candidate for the benefits offered by IA. Applied to PV, IA offers a smart and scalable solution to change the upwards trajectory of PV costs and represents a completely new proposition because it allows pharmaceutical companies to make profound changes to their approach to PV processes. IA is not about automating or enhancing or even replacing a process. In many cases, IA about removing entire processes and the need for them.
By eliminating repetitive tedious manual processes, IA speeds up the PV process and reduces the margin for human error, ensuring more accurate and consistent reporting. This also frees up valuable professional resources which can redirect their expertise toward more complex and strategic aspects of PV, such as data interpretation and safety strategy formulation. This shift elevates the quality of work and paves the way for more insightful and data-driven decision-making. In this way, IA offers a sustainable and forward-thinking solution to the challenges plaguing manual PV reporting.
Benefits of PV Platforms Powered by Intelligent Automation
Integrating IA into PV platforms is not just a technological advancement; it’s a transformative shift that brings tangible benefits, for example:
- Decreased time, expense and risk
One of the most immediate benefits of IA is the significant reduction in the time required for reporting. Tasks that once took hours, if not days, can now be completed in a fraction of the time. This expedited process ensures timely submissions and faster response times, crucial in a domain where reducing time can improve patient safety.
With automation removing the bulk of repetitive manual tasks, companies experience reduced labor and training costs, fewer error rectifications and process redundancies, resulting in significant cost savings. And since automated processes are governed by precise algorithms and ML models, they bring consistency and accuracy to the table, reducing the risk of manual inaccuracies.
- Insights for decision-makers
The power of IA lies in executing tasks and its ability to analyze vast datasets. PV platforms equipped with this technology can sift through enormous amounts of data, identifying patterns, trends and anomalies. This can provide invaluable additional insights that were previously overlooked or too time-consuming to extract, adding more value to data.
These data-driven insights are goldmines for regulators, industry bodies and internal experts. They offer a clearer picture of drug safety profiles, potential adverse effects and patient feedback, information crucial for making informed decisions, for example, modifying drug dosages, issuing safety warnings, even recalling products.
With a clearer understanding of the data at hand, decision-makers can make more informed judgments about the safety and efficacy of marketed products. This improves patient safety and can bolster the public reputation and trustworthiness of pharmaceutical companies.
The future of PV with intelligent automation
Looking ahead, the fusion of PV and automation into IA offers vast potential for growth and refinement. As ML algorithms become more sophisticated and data processing capabilities expand, advanced PV platforms will be capable of predictive analysis, forecasting potential adverse events before they manifest or even integrating real-time patient feedback to provide a more holistic view of drug safety.
Embracing automation enables greater consistency, accuracy and timeliness. It streamlines the PV reporting process, removing the inconsistencies that plagued manual systems. With automation handling the heavy lifting, errors are reduced, leading to more accurate reporting. Moreover, the speed at which automated systems operate ensures that reports, analyses and insights are generated promptly, a crucial factor in a field where delays can have dire consequences.
At its core, PV is about mandatorily ensuring the safety and well-being of patients. As automation becomes integral to PV, its role transcends beyond reporting. By continuously monitoring, analyzing and alerting stakeholders about potential risks, it ensures patient safety remains at the forefront, with rapid responses to possible threats.
The need for constant evolution
The technology-driven PV journey is constantly evolving, presenting opportunities to replace the outmoded outsourcing models once considered a complete solution for rising PV costs. The limitations and short-term nature of outsourced operations and the inherent risks of fragmented processes have reinforced the urgency of finding more sustainable and efficient alternatives.
IA offers the promise of efficiency, accuracy and timely insights, representing a way forward that is not just about cost-cutting but elevating the entire PV process. By harnessing the power of Intelligent Automation, companies can transcend the limitations of manual AE handling and data analysis, ushering in an era of future-proofed, scalable, data-driven insights and proactive patient safety measures.
Stephanie Senn
As Product Management Lead for IQVIA Vigilance Signal, Stephanie Senn is responsible for driving the overall strategy for IQVIA’s signal detection and management solution. She is focused on identifying innovative opportunities to continuously improve the solution and support evolving requirements. Senn has eleven years of experience within safety and pharmacovigilance and worked within industry before joining IQVIA in 2018. She utilizes her knowledge and first-hand experience in signal management to guide and support clients in the adoption of optimized, compliant signal processes. Senn obtained her bachelor's degree in Neuroscience from the University of Manchester and passed her master's degree in Drug Development Science with Distinction at King’s College London.
