AI: Driving Efficiency and Strengthening Governance
At the recent Pharmaceutical Compliance Congress West in San Diego, discussions centered around how AI can streamline manual tasks and enhance governance in the pharmaceutical sector. Notably, compliance program directors from leading companies shared insights on leveraging AI to manage third-party risks and improve compliance strategies.
Case Study: Third-Party Risk Management
One prominent case study featured a compliance program director who explained how her organization utilized AI to tackle the challenges of third-party risk management, especially during the early stages of being a small startup. Faced with the complexities of managing global vendors and healthcare provider partners, she partnered with a vendor to implement an automated AI platform that became crucial for her compliance approach.
The platform allowed her to input basic information about any third party, vendor, or healthcare provider partner, and it efficiently conducted thorough due diligence checks. This included verifying licenses and ensuring that partners were valid and active practitioners. The system also performed extensive checks across media platforms to protect the organization’s reputation by ensuring that potential partners were trustworthy.
Post-onboarding, the AI tool continuously monitored vendors, providing real-time alerts about emerging risks such as lawsuits or negative press, thus enabling proactive risk management and safeguarding the organization’s standing.
AI as a Game-Changer
The implementation of the AI platform significantly reduced the manual workload associated with vendor management. The compliance director noted, “It saved us a ton of time,” emphasizing that the AI-enabled onboarding of vendors could be completed in minutes, even in countries with complex compliance requirements.
However, despite the advantages of automation, the importance of human oversight was stressed. The compliance director indicated that when the AI flagged a third party as not approved, it necessitated additional investigation to confirm the accuracy of the data, ensuring that false positives or negative hits were addressed appropriately.
Empowering Compliance Teams with AI
A vice president from another biotech company shared insights on how enterprise-level AI tools can act as a force multiplier for compliance teams. With small teams often tasked with doing more with fewer resources, AI has facilitated greater productivity. For instance, during a policy update, AI automated the creation of presentation decks, drastically reducing the time and effort typically required for such tasks.
AI also assisted with administrative workloads, helping compliance professionals remain organized by summarizing daily activities, managing emails, and reminding them of missed tasks. Furthermore, AI tools provided transcription and summary capabilities during meetings, eliminating the need for manual note-taking and ensuring accountability.
Addressing Risks in AI Implementation
Despite the efficiencies gained through AI, caution was advised regarding potential risks. One incident involved an AI tool logging into a clinical call on behalf of a participant, resulting in unauthorized distribution of a summary, raising concerns about consent and compliance with data security regulations.
To mitigate such risks, it was recommended that organizations implement AI tools with appropriate safeguards, ensuring that security measures are in place to prevent data breaches and maintain compliance with legal standards.
Conclusion: Balancing Efficiency and Governance
In conclusion, while AI presents substantial opportunities for enhancing operational efficiency and governance, organizations must approach its implementation thoughtfully. Establishing governance frameworks, managing AI applications effectively, and ensuring that personnel are aware of their responsibilities can help organizations embrace AI while minimizing potential risks.
