How intelligent automation offers a way to transform pharmacovigilance

Pharmaceutical production can be enhanced by embracing AI and automation to bring efficiency to drug safety monitoring.

In recent years, the pharmaceutical industry has grappled with multiple challenges, not least of which is the escalating cost associated with pharmacovigilance.

A mandatory element of pharmaceutical production, pharmacovigilance (PV) has become more demanding than ever because of 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 no more cost-benefit from the manual supply chain. What was once a cost-effective option soon becomes another area with mounting operational expenses.

This cyclical pattern has created a phenomenon in which 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 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, natural language processing 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 enables 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 intelligent automation platforms

Integrating IA into PV platforms is not just a technological advancement; it's a transformative shift that brings tangible benefits. These include the following.

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 because automated processes are governed by precise algorithms and machine learning 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 or 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 machine learning 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.

Stephanie Senn is a product manager for Vigilance Signal.

More for you

Loading data for hdm_tax_topic #better-outcomes...