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How AI is shaking up compliance in the life sciences industry
Transforming compliance with Artificial Intelligence
Mar 03, 2025
Join our webinar to explore key use cases from leading players we have been working with, understand regulatory considerations, and envision the future of compliance with Generative AI in your organization.
The life sciences industry is as dynamic as ever as organizations strive to meet patient’s needs. From a compliance perspective, regulations continue to evolve, and companies are under increasing internal pressure to drive efficiency and lower cost to be able to redirect their focus and efforts on drug development.
The rise of Artificial Intelligence (AI), especially the use of Generative Artificial Intelligence, presents all functions across the entire industry, including compliance, with an innovative approach to work. It offers exciting new methods to streamline processes, reduce risks, and boost efficiency. Let’s dive into how AI is changing the game in compliance for the life sciences industry, focusing on specific use cases, and its impact on the future of compliance.
Why compliance matters more than ever in life sciences
Compliance works to enable businesses to follow laws, regulations, and industry standards that safeguard public health and safety. If a company doesn’t comply, it can face hefty fines, damage to its reputation, and major operational hiccups. Traditionally, compliance has been a time-consuming job, often involving manual checks, reports, and audits. But thanks to AI, companies can now manage compliance more easily and accurately and allow compliance functions to concentrate more efforts on valued business partnering.
The hurdles of traditional compliance
Before we get into how AI can help, let’s look at the challenges of old-school compliance methods in life sciences:
- Too many rules: The sheer number and complexity of regulations in life sciences can be overwhelming. Different regions have different laws, making it hard to keep up especially for lean compliance teams.
- Manual work: Compliance tasks done by hand are prone to mistakes, slowdowns, and missed issues. Some organizations may be operating with compliance actually working within processes as activity or transaction approvers.
- Resource heavy: Compliance needs a lot of resources and business needs are increasing as companies work to ensure their employees are adequately supported by consumable policies, effective training, and embedded compliance within workflows. Compliance teams also require people and skills to consume data, review documentation – which could be in various languages and assess risk. Smaller companies might struggle to meet these demands.
Understanding the client perspective
Recently IQVIA engaged over 100 compliance officers on the topic of AI in a series of events across EMEA. Much of the discussion was focused on the potential role of AI in addressing the above challenges through the ability to enhance efficiency, accuracy, and scalability in compliance processes. We surveyed the attendees' current state with regards to the implementation of AI/Generative AI capabilities within their organization and specifically for compliance teams and use cases. While we were surprised to see that 44% of participants were already leveraging AI/Generative AI capabilities for compliance, the resulting dialogue confirmed our expectations that implementations were limited to simple use cases targeting operational efficiency (Figure 1).
Figure 1: Status and perspectives of AI/Generative AI usage in Compliance
When diving into the discussion with participants to further understand where AI/Generative AI capabilities have the potential to drive the greatest impact for our client, we identified concrete use cases, ranging from quick wins to strategic initiatives. This demonstrates the huge potential of AI/Generative AI across Commercial Compliance and how it can drive a transformational impact across organizations.
How AI can, and already is, changing compliance in life sciences
AI is a game-changer in life sciences compliance and as we saw above it has a huge potential, offering several benefits to overcome traditional challenges. Here’s how:
Enabling access to compliance guidance
AI-powered tools can consume existing policy information allowing employees who are both office and field based to access real-time guidance, backed with internal approved references, ensuring adherence to the latest regulations and policies, and resulting in quick access to relevant and easily digestible information to streamline business and compliance activities.
Personalized compliance trainings
AI can significantly enhance the design and execution of personalized training programs. Inputting the information of different team profiles, roles, and responsibilities, AI can create persona-based training paths, for each individual to follow at their own pace based on their specific needs and skill gaps.
Automating regulatory monitoring
AI-powered tools are revolutionizing the way companies in the life sciences industry manage regulatory compliance. By continuously monitoring vast amounts of data, these tools can quickly identify relevant updates and changes in regulations. This proactive approach not only helps businesses stay compliant but also saves time and resources that would otherwise be spent on manual monitoring.
Boosting risk assessment
AI algorithms can analyze past data and spot patterns that indicate potential compliance risks, such as adverse drug reactions or manufacturing deviations. It can additionally anticipate the impact of new regulations before they are officially implemented. By identifying anomalies, deviations from standard practices, and encouraging proactive compliance, AI helps companies manage risks before they become bigger problems. This predictive power makes decision-making more effective.
Streamlining compliance monitoring and auditing
AI can make monitoring and auditing much easier by automating data collection, analysis, and documentation review. This alleviates the burden on compliance teams and ensures reports are accurate, consistent, and timely. Automated auditing tools can also perform real-time checks, flagging potential issues for further review.
The future of AI in life sciences compliance
The future of AI in compliance for the life sciences industry looks bright, with ongoing advancements set to further reshape the field. Here are some trends to watch:
- Strategic shift for compliance officers: Commercial officers are transitioning from an operational to a strategic role. Early adopters will lead the way in setting new standards and innovative compliance practices, as compliance officers move towards a more strategic focus.
- Predictive risk assessment: AI-enabled monitoring and insights generation will facilitate the shift from reactive to predictive risk assessment. This trend will enable earlier detection of compliance risks, provide tools for content production, and increasingly support the generation of compliant content. While audits will still be necessary, AI will play a significant role in risk assessment.
- Global compliance with local specificities: AI will simplify the process of navigating different regulations across countries, providing a global overview with insights into local specificities. This will enable the creation of global standard operating procedures (SOPs) that align with company imperatives, while also allowing for customization based on local regulations.
- Better understanding of SOPs and Regulations and increased compliant execution: Natural language support will facilitate a simpler understanding of SOPs and regulations across the company. Teams will be able to easily access guidance for specific use cases without requiring in-depth knowledge of laws and regulations, reducing the need to constantly consult compliance teams for their daily tasks.
Wrapping up
AI is transforming how life sciences companies handle compliance. By automating tasks, boosting risk management, and improving efficiency, AI helps organizations achieve and maintain compliance more easily and accurately. As AI technology continues to evolve, its role in compliance will only grow, offering new opportunities for innovation and excellence. We are excited to see how Generative AI and, most recently, Agentic AI, with its new automated capabilities to plan and perform interdependent decisions will support compliance. Embracing AI in compliance is not just smart; it’s essential for companies aiming to thrive in a complex regulatory world.
To learn more about IQVIA’s Compliance AI offerings click the ‘Contact us’ button in the right-hand corner or the page, or to find out how IQVIA is revolutionizing compliance in the Life Sciences industry with AI-powered solutions, visit www.iqvia.com/healthcaregradeai