#FutureReadyHealthcare
Shaping the Future of Pharmacovigilance: Industry Trends on Transformation
In the world of life sciences organizations, Pharmacovigilance (PV) plays the role of a vigilant guardian by diligently watching over the safety and well-being of patients. To understand more about the intricate landscape of PV, Indegene embarked on a journey and delved deep into current practices, unveiling the challenges that PV professionals are determined to conquer, exploring how diverse organizations harness the power of technology, and catching a glimpse of the future. We at Indegene listened to the demands that organizations placed upon their vendors and uncovered the unmet needs of PV professionals. This industry survey report sheds light on the industry's unwavering commitment to the safety of patients, the pursuit of process excellence, and the untapped potential of transformative technology. This report also serves as a benchmarking opportunity for PV teams across the globe, ready to improve their performance against competitors.
Insights from 100 PV Professionals Across the USA and Europe, Representing Various Seniority Levels
Our study yielded the following key findings:
Priority Areas in PV: This report reveals that 40% of respondents have their sights set on “elevating compliance,” while 30% are focused on “elevating quality,” and 29% aim to achieve “operational efficiency.” It indicates a strong commitment and a healthy balance towards regulatory compliance, patient safety, and process optimization within the industry.
Transformation: More than a quarter (29%) of the respondents see “Adverse Event (AE) Monitoring and Intake” as a prime candidate for transformation within the next 12 months. Additionally, “QMS and Audit Readiness” and “Signal Detection and Management” also garnered significant attention for potential transformation.
Automation Uptake: ~25% of the survey respondents reported their organizations are currently operating with 20% automation in Case Processing. However, they anticipated a substantial shift of Case Processing automation toward 60% and above in the next 12 months, displaying a clear upward trend toward automation.
AI/ML Adoption: The survey reveals that only 5% of organizations have used AI/ML extensively for AE Monitoring and Intake, whereas approximately 18% of respondents still rely on basic tools. On average, 47% rely on automation without AI/ML for Case Processing, Aggregate Reporting, and Signal and Risk Management. It underscores the need for improvement in technology adoption maturity levels across PV processes.
Outsourcing Trends: Within the current landscape, the percentage of organizations outsourcing more than 60% of their operations is at 21% for Signal and Risk Management, 26% for AE Monitoring and Case Intake, and 40% for Case Processing. Looking ahead, the data indicates a growing trend toward higher levels of outsourcing in the next 12 months. Additionally, organizations are demanding improvement in flexibility, alignment with long-term vision, and innovation from their vendors.
The survey encompassed the insights of 100 PV professionals, reflecting a diverse and widespread distribution of regional responsibilities. 95% of respondents represented safety and PV operations, with the remaining 5% represented IT operations for PV and safety (Figure 2) across a healthy mix of large, mid-size, and small pharmaceutical organizations. Notably, 32% of respondents held roles focusing solely on North America, whereas 28% held global roles with North America as their primary focus market. 14% concentrated solely on the EU 5 countries, and another 14% held global roles with EU5 as their primary target market (Figure 4). Within the realm of PV and/or IT operations, the majority of professionals, comprising 76%, were overseeing adverse event case management, followed closely by 74% specializing in Signal and Risk Management, and 66% had Aggregate Reporting responsibilities (Figure 5), indicating multiple focus areas per PV professional. This survey also ensured an equitable distribution of seniority levels, with 20% each representing CXOs/EVPs/Presidents, SVPs, and VPs, while 40% occupied roles as Executive Directors, Senior Directors, and Directors (Figure 1). This comprehensive survey tried to mirror the multifaceted landscape of organizations across the PV spectrum.
Navigating Strategies and Priorities in Pharmacovigilance
So, what are the leading objectives that drive PV teams forward? An impressive 40% of respondents have their sights set firmly on “elevating compliance.” These organizations are steadfast in their dedication to upholding regulatory standards and ensuring the safety of their products. Another 30% are focused on “elevating quality,” demonstrating a profound commitment to patient well-being. At the same time, another 29% are embarking on a journey to achieve “operational efficiency,” striving for a balanced approach to streamline their processes. This highlights a desire for leaner and more efficient PV operations (Figure 6).
How do organizations intend to achieve this triad of objectives: compliance, quality, and efficiency? This survey revealed a tapestry of strategies (Figure 7).
“Early Safety Issue Identification” emerged as the top priority (Rank 1) among 25% of the respondents, emphasizing the need for swift detection of safety concerns. Another 25% considered it as second priority (Rank 2).
“Seamless Integration of PV Systems and Historical PV Data” ranked second in terms of priority, underscoring the importance of seamless data flow across systems to ensure compliance, quality, and efficiency.
“Better Management of Local Affiliates and License Partners” ranked third, emphasizing the need for rigorous procedures in PV agreements with clear role definitions, reporting responsibilities, performance metrics, and risk-based audits of local affiliates and license partners. Additionally, this ranking emphasizes investments in technology and data systems to enable efficient data sharing. Other strategies could include the development of robust communication platforms and comprehensive training programs.
Transformation on the Horizon
This survey has also tapped in to investigate areas where the promise of transformation lies. We asked the survey respondents to rank the areas within PV operations based on the potential for transformation in the next 12 months (Figure 8).
Nearly a quarter of the respondents see “AE Monitoring and Intake” as a prime candidate for transformation in the upcoming 12 months. “QMS and Audit Readiness” generate moderate interest, while “Signal Detection and Management” also attracts significant attention. “Aggregate and Safety Reporting,” however, sees mixed opinions, suggesting that organizations may have varying levels of readiness and confidence in this area. The diverse perspectives on these avenues of transformation indicate that the industry is not adopting a one-size-fits-all approach. Instead, organizations are tailoring their strategies to address specific needs and challenges within their PV operations. Comprehending this ranking holds significant importance for organizations and PV professionals alike. It serves as a valuable compass for resource allocation, risk mitigation, strategic planning, benchmarking, and enhancing efficiency and effectiveness.
The Current PV Landscape
Understanding the existing practices is essential to pave the way for a prosperous tomorrow. So, how do organizations see their current practices in the following areas of PV?
Adverse Event (AE) Case Management (Figure 9): 75% of survey respondents reported practicing "skill-based routing and review of high-risk AE reports.” As 59% of survey respondents embraced "real-time customization of questions to reduce unstructured information during case intake," it presents an opportunity for improvement, allowing for the utilization of advanced algorithms and tools that can adapt in real time. This would guarantee that the questions asked are consistently relevant and precisely tailored to each case's distinct circumstances.
Only 44% of the surveyed respondents actively used technology to screen literature and other AE sources, proactively flagging potential AEs for manual review. It indicates that 66% of the survey respondents took a reactive approach to AE review. Moreover, merely 40% utilized technology to provide real-time alerts or information to reviewers during the review process. Organizations must explore avenues to streamline these manual procedures, to boost efficiency and effectiveness. The challenge lies in identifying criteria and establishing a robust system to determine better the necessity of manual review and identify the types of information that can enhance the review process. This revelation prompts an intriguing question: Are we fully leveraging technology-driven solutions for quality control and medical review of AE cases?
The survey data also revealed the extent of manual processing required to manage unstructured AE reports (Figure 10). A mere 6% of respondents enjoy minimal manual processing, demonstrating highly efficient automation. In contrast, 40% maintain a balance between manual and automated processes, with 10%-30% of their AE reports requiring manual intervention. In 45% of organizations, a significant portion falls within the 30%-60% manual processing range, highlighting a significant demand for manual handling.
Aggregate Reporting (Figure 11): Survey respondents in the Aggregate Reporting field reveal that they are increasingly prioritizing efficiency and standardization, and that there is ample room for improvement. Specifically, 50% of respondents utilize “standard templates and content reuse” to enhance authoring efficiency, while approximately 42% have embraced lean writing principles for content discoverability and improved readability. Although 37% of organizations have adopted technology for “quality checks and error alerts,” many have yet to fully leverage its capabilities. Additionally, only half of these experts have implemented streamlined submission planning and management processes.
Signal and Risk Management (Figure 12): 61% of respondents reported that they use a “rigorous evidence-based evaluation framework” to assess the veracity of signals. Organizations need to consider investing more in data analytics and real-time monitoring approaches. Even though “real-time alert mechanisms for cases of interest” promotes informed decision-making and reduces the likelihood of reacting to false or unreliable signals, only 43% of professionals use them. For PV organizations not applying it, the primary downside is an increased risk of delayed or missed responses to critical issues. Without such mechanisms, organizations may fail to promptly identify emerging risks or AEs, that may potentially lead to regulatory non-compliance.
Embracing Automation: PV Professionals Anticipate >80% Automation in Safety Operations
While there is significant progress towards efficiency and standardization in certain areas, there is clear increased need for greater automation. But how do PV professionals perceive current automation levels in their organizations, and what do they anticipate for the next 12 months?
In the realm of AE Monitoring and Intake practices (as depicted in Figure 13), the majority (43%) indicated their current automation level stands at 40%, with only 20% reaching 60% automation. Conversely, 33% of respondents reported a mere 20% automation. However, the surveyed respondents expressed their confidence of a substantial increase in automation levels over the next 12 months, with 42% aiming for 80% and above. This signals a growing recognition of the advantages of automation, including enhanced efficiency, accuracy, and compliance, in the management and monitoring of AEs related to pharmaceutical products.
Regarding Case Processing operations (as shown in Figure 14), current automation levels are more favorable compared to AE Monitoring and Intake. Only 1% of respondents presently function at 80% automation. Notably, a significant 43% are anticipating a transition to >80% automation within the next 12 months.
In Aggregate Reporting (as depicted in Figure 15), the current practice shows that over half of the respondents have attained only 40% automation level, with just 22% operating at 60% automation. Interestingly, no organization has reported reaching 80% or 100% automation in their current Aggregate Reporting processes. In the next 12 months, a substantial 47% intend to reach 60% automation, while 22% are setting their sights to achieve 80% automation.
The current level of automation in Signal and Risk Management (Figure 16) within organizations is distributed as follows: The majority (44%) reported 40% automation, while only 4% reported 80% automation. In the next 12 months, the most significant anticipated changes are in the 60% automation category, expected to rise to 42%, and the 80% automation category, projected to increase to 23%.
The Dance with Technology
To manage AE Monitoring and Intake (Figure 17), approximately 18% of respondents reported relying on basic tools. This reliance on manual or outdated methods hinders efficiency and increases the risk of errors. While 26% of respondents reported minimal use of AI/ML, and only 5% of organizations have used AI/ML extensively in AE Monitoring and Intake. These trends resonate throughout the broader PV landscape, with similar manifestations in Case Processing, Aggregate Reporting, and Signal and Risk Management functions. Workflow management adoption category across all these functions ranges from 10% to 24%. Automation without AI/ML is significantly higher in Case Processing (46%), Aggregate Reporting (47%), and Signal and Risk Management (48%) compared to AE Monitoring and Intake. Extensive use of AI/ML remains relatively low in all three functions, with adoption rates ranging from 7% to 8%. These revelations highlight a distinct opportunity to explore the potential of AI/ ML in augmenting AE monitoring, Case Processing, Aggregate Reporting, and Signal and Risk Management. AI/ML algorithms hold the promise of unearthing hidden patterns within adverse event data, facilitating the timely detection of safety signals, and seamless automation of routine tasks. While some organizations have made strides in adopting AI/ ML, there is still a significant opportunity for growth and innovation in the PV sector. As the industry continues to evolve, organizations that strategically leverage advanced technologies will enhance their safety monitoring capabilities and contribute to improved patient outcomes and drug safety, ultimately leading to more consistent and efficient processes.
However, the pivotal question remains: Can technology truly pave the way for superior outcomes in PV? The majority of respondents believe in technology's transformative potential, with 45% believing it will lead to mid-level efficiencies and 61% foreseeing its high scalability benefits (Figure 18). What is particularly interesting is the emphasis on "Better Decisions," as over 42% of the professionals believe technology adoption will highly enhance decision-making processes. This collective optimism underscores the industry's recognition of technology as a catalyst for positive change, poised to enhance efficiency, scalability, decision-making, and regulatory adherence across the board.
So, what are the barriers to technology adoption? The top barriers as per PV professionals are lack of investment appetite/business case for ROI, integration challenges with the current ecosystem of PV operations, and the lack of in-house skills (Figure 19).
Generative AI: Is It the Next Frontier in Pharmacovigilance?
Notably, a mere 16% of respondents have yet to commence experimentation, and a significant 50% are actively experimenting with Generative AI, although they anticipate a 6-month or longer timeline before full implementation (Figure 20). Meanwhile, 27% are closer to going live, and expect to integrate AI applications in less than 6 months, showcasing active progress in AI adoption. Additionally, 7% of respondents are early adopters already utilizing generative AI, indicating the transformative potential of AI in revolutionizing PV practices.
However, it is important to note that while there is excitement surrounding AI's potential, concerns regarding data privacy, regulatory compliance, and the need for robust validation processes have also emerged as crucial factors in the adoption of generative AI-based applications in PV. (Figure-21) These concerns highlight the need for a balanced approach and need for exploration with identified use cases within secured environments and under the guidance of experts.
The Outsourcing Odyssey
Examining current and projected outsourcing levels within organizations is a compelling insight into the strategies of PV professionals across various facets of their organizational functions. Notably, nearly half of the organizations are currently outsourcing 40% of their AE Monitoring and Intake processes (Figure 22), demonstrating that they considerably rely on external expertise for this crucial PV function. Similarly, Aggregate Reporting (Figure 24) also exhibits a strong inclination toward outsourcing, with a staggering 46% of organizations currently outsourcing 40% of operations. This suggests that many organizations prefer to delegate the complex task of Aggregate Reporting to external partners, which involves compiling and analyzing safety data over extended periods. It is noteworthy that although outsourcing is prevalent, very few organizations opt for complete outsourcing, with just 3% outsourcing 100% of AE Monitoring and Intake activities, demonstrating the importance of maintaining some level of in-house control and oversight in these critical areas. Looking ahead, the data indicates a growing trend toward higher levels of outsourcing in the next 12 months, with a significant percentage of organizations planning to increase their outsourcing in functions such as Case Processing (Figure 23) and Aggregate Reporting, likely driven by the desire to streamline operations and tap into specialized resources while still maintaining a degree of in-house management.
The top drivers for outsourcing in PV functions vary but share common themes (Figure 26). In AE Monitoring and Intake, bridging the “Skill/Expertise Gap” was the foremost driver, closely followed by “Technology” and “Cost.” In Aggregate Reporting, “Cost” took precedence, followed by the "Skill/Expertise Gap" and “Technology.” Similarly, in Signal and Risk Management, “Cost” remained the primary driver, with the “Skill/Expertise Gap” and “Technology” following closely behind. Across all functions, organizations emphasized the importance of cost-efficiency, expertise, and technological advancements when making outsourcing decisions, while considerations of scalability and temporary resourcing needs also played a significant role in shaping these decisions.
Vendor Perception in the World of PV Organizations
A substantial percentage of PV professionals reported that the majority of vendors excel in resource expertise, agility, and compliance to Service Level Agreements (SLAs), instilling confidence in their ability to deliver high-quality services efficiently. 61% also expressed satisfaction over competitive pricing and cost savings through vendors, and 16% said that vendors exceeded expectations with their pricing. However, organizations demand substantial improvement in areas such as flexibility, alignment with long-term vision, and innovation (Figure 27).
Conclusion
Drawing insights from our survey analysis, we propose the following recommendations for life sciences companies to align with the evolving landscape of PV.
Invest in Technology and Automation: The report highlights a growing trend toward automation in PV processes, such as AE monitoring and Case Processing. To stay competitive and ensure efficiency, life sciences companies should invest in advanced technologies, including AI and machine learning, to enhance their PV operations. Consider implementing real-time alert mechanisms and AI/ML algorithms to improve the accuracy and speed of safety signal detection and AE monitoring.
Align Vendors with Your Long-term Strategic Goals: This report suggests that while vendors excel in resource expertise and compliance with SLAs, there's room for improvement in areas such as flexibility, alignment with long-term vision, and innovation. Life sciences companies should foster closer strategic collaboration with their PV service providers. Encourage vendors to align their services with company's strategic goals and explore innovative solutions to improve PV processes.
Prepare for Generative AI Adoption: With generative AI emerging as a potential frontier in PV, companies should actively explore its applications while addressing concerns related to data privacy and regulatory compliance. Develop a strategy for integrating generative AI into your PV operations, focusing on use cases that offer clear benefits in terms of efficiency and accuracy.
Evaluate Outsourcing Strategies: Assess your organization's outsourcing levels in PV functions and consider the advantages of tapping into specialized resources while maintaining some in-house control. Pay close attention to the drivers for outsourcing, such as bridging skill/expertise gaps and cost-efficiency. Tailor your outsourcing strategy to meet specific needs in AE monitoring, Case Processing, and Aggregate Reporting.
Appendix
1.
The survey encompassed North America and five European Union countries (France, Germany, Italy, Spain, and the United Kingdom)
2.
Not applicable*: zero or minimal automation
3.
Not applicable**: zero or minimal outsourcing
Authors
Sameer Lal
Nikesh Shah
Chandan Malaker