CAGE CODE: 9RGP6 | UEI: ZRCA815S8X9

Building Global Compliance Resilience in Clinical Trials: Cybersecurity at ICON

The company’s decentralized systems and rapid growth created regulatory gaps that threatened vendor relationships and contract readiness. ICON also faced complex regulatory challenges when handling biomedical data, pharmaceutical research, and patient information in Russia, China, Ukraine, and India—each with its own evolving data security policies. Additionally, cross-border data transfers and vendor security raised concerns. PRA’s legal and compliance teams were under pressure to negotiate cybersecurity terms that would satisfy varying international laws, while ensuring ongoing vendor performance and risk mitigation.

The Challenge

The company’s decentralized systems and rapid growth created regulatory gaps that threatened vendor relationships and contract readiness.

The Approach

Amy developed an enterprise risk management plan, created a cybersecurity agreement playbook for clients, and oversaw GDPR, HIPAA, and FDA audit alignment. She facilitated RFP compliance and participated in client negotiations.

The Impact

Strengthened enterprise audit posture for FDA and EMA Reduced vendor security exceptions through playbook-driven risk alignment Secured multiple global contract wins via proactive compliance tracking

The Breakdown: