Case studies

A Canadian mid-size pharma company partnered with ICON to support FDA approval of a generic injectable for opioid overdose treatment. ICON’s Regulatory Affairs team guided the sponsor through the ANDA process, including pre-submission, filing, and responding to FDA review queries.

This case study highlights how a large sponsor reduced integration development time by 80%, accelerating study
start-up and cutting costs through the standardisation of IRT integration across programmes.

A global pharmaceutical organisation sought ICON’s help to design an end-to-end regulatory labelling process for their growing organisation.

A global biopharma sponsor partnered with ICON for a Phase 1/2 oncology study. ICON piloted a site-focused activation model with dedicated Site Partners, supported by centralized oversight and tech-enabled processes, to reduce site burden and accelerate timelines.

A top 10 pharma company partnered with ICON to improve study start-up in the U.S., shifting from an FTE model to unit-based delivery. Using proprietary systems and centralized teams, ICON reduced cycle times and identified further efficiency opportunities.

A pharma client partnered with ICON to support EU and US approval of a new diabetes therapy. ICON’s APS team sourced, labeled, and shipped comparator and study drugs for a complex phase 1 trial, helping meet the sponsor’s accelerated timeline.

ICON enabled successful enrollment and data integrity in two global Phase 3 HCM trials through expert site selection and CPET standardization. Despite rare disease challenges and competitor pressure, the program advanced smoothly.

In July 2024, a global biopharma client partnered with ICON to expand functional support. Starting with Clinical Operations and TMF roles, the partnership grew to over 60 FTEs and now includes Clinical Quality, Systems Experts, and Late Phase, with further expansion underway.

In February 2023, a global biopharma company added ICON to its vendor ecosystem, initially focusing on Clinical Operations. Within a year, ICON grew to represent 20.5% of total FSP resourcing, outperforming expectations and becoming a key partner. ICON has since expanded into multiple services, offering flexible commercial models and scalable support across the client’s evolving needs.

ICON developed, validated, and implemented a custom flow cytometric Receptor Occupancy Assay, delivering critical biomarker data for a complex monoclonal antibody clinical trial.

ICON successfully streamlined clinical operations during a post-market registry study by adapting sponsor SOPs mid-study, enabling a seamless transition to ICON-led project management while maintaining operational continuity and site performance.

A top 20 pharma subsidiary scaling plasma-derived therapies asked ICON to review their processes and plan for growth. With plasma reliant on donations, new centers were opening to meet demand and ensure patient access to life-saving treatments.