Top Risk Areas Internal Audit Leaders Must Address in Life Sciences - Crowe LLP

As life sciences organizations approach 2026, internal audit teams are navigating a rapidly evolving risk environment driven by accelerated innovation, expanding regulation, and growing financial pressure. AI-driven research and development, connected medical devices, decentralized clinical trials, and increasingly complex global supply chains are introducing new risks that traditional audit approaches were not designed to address.

This guide from Crowe highlights five priority risk areas internal audit leaders in life sciences should evaluate as they plan for the year ahead. It provides practical insight into how internal audit teams can align innovation with compliance, strengthen governance, and support enterprise resilience while protecting patient safety and maintaining stakeholder confidence.

Inside this guide, you will explore five critical areas internal audit leaders should be evaluating today, including:

• Medical device cybersecurity risks that now extend beyond data protection to directly impact patient safety and care continuity
• Governance and data integrity challenges created by AI adoption across research, clinical, and commercial operations
• Risks to trial integrity in decentralized and technology-enabled clinical trials
• Financial pressures driven by the patent cliff and evolving pricing and market access dynamics
• Supply chain resilience, traceability, and third-party oversight required to sustain operations and regulatory compliance

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