ICON partnered with a leading BioPharma company to support pharmacovigilance (PV) operations for a novel indication product. Following six years of collaboration during clinical development, ICON transitioned to post-marketing support upon product approval and launch in the US and EU. The product’s market emergence triggered exponential growth, requiring a scalable, transparent, and collaborative approach to meet evolving regulatory and operational demands.

The sponsor faced several unique challenges in launching and scaling a first-in-market (FIM) product:

• Resourcing a FIM product, with a large patient population, and limitations in rigid forecasting models.
• As a first in indication product, there were no pre-existing models of market growth.
• Collaborating with staffing growth and SME onboarding for both sides of the partnership.
• Additional regulatory authority oversight as a FIM product.

ICON developed a tailored operating model that proactively addressed each challenge while embedding the flexibility needed to respond to emerging real-world data and evolving market dynamics.

• Collaborative design and transparency: ICON adopted a “collaboration-first” approach, ensuring shared access to workspaces, SOPs, database outputs, and planning tools. This enabled real-time alignment and customisation as the product matured.
• Oversight and forecasting models: Long-term forecasting models based on projected market growth and release strategies enabled department heads to set monthly targets and implement selective hiring across time zones. These models were paired with weekly assignment-to-workflow analyses, allowing timely adjustments to maintain case reporting timelines.
• High-frequency quality monitoring: The team increased the cadence of KPI assessments, particularly case quality, leveraging the high data volume and transparent client collaboration. This enabled early detection of trends and rapid process adjustments.
• Flexible resourcing strategy: A hybrid team structure was implemented, combining a core group of dedicated resources with cross-trained “floating” staff. This model ensured scalability during peak periods and maintained continuity across time zones and workflows.
• Structured onboarding and support: We introduced a robust onboarding framework with clear goals, capability tracking, and multi-layered support networks. This ensured consistent performance and addressed the subjective nature of post-marketing data interpretation.
• Automation implementation: To manage rapid growth and shifting resource demands, automation was implemented across the safety database wherever feasible. Enhancements included field pre-population, custom workflows, auto-reportability and licence assessments, gateway submissions, and advanced listing configurations. These solutions reduced team workload, manual errors, and reliance on individual contributors, while improving efficiency, consistency, training scalability, and overall quality

ICON’s strategic approach delivered measurable impact across quality, scalability, and client satisfaction:

• Successfully managed a 6750% increase in case intake within the first 16 months post-approval
• Maintained 100% KPI achievement for case quality throughout 2025
• Met all reporting timelines, even during 30% week-on-week intake surges
• Achieved high client satisfaction across oversight, collaboration, and resource management
• Realised long-term efficiency gains and cost savings through automation and flexible delivery