Therapeutics case studies

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.

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.

A small Asia-based biotech engaged ICON to manage its EU orphan drug designation submission for a treatment targeting Dercum’s disease. The designation was key to supporting a planned Phase 3 study and expanding into the EU, where the company had no existing presence.

ICON partnered with a leading pharma company to scale its global vaccine program using flexible, custom FSP solutions. By combining dedicated teams with on-demand support, ICON helped expand trial reach, adapt to changing needs, and deliver nearly $10M in annual cost savings.

A global, multi-centre trial is evaluating cardiac radioablation (CRA) vs. repeat catheter ablation for high-risk VT patients. Spanning 7.5 years, the study involves 380 randomized patients across 20+ sites in the U.S., U.K., and Germany.

A large multi-year IVD colorectal cancer study faced enrolment challenges across 180+ sites and 28,000 participants. The sponsor turned to ICON’s Medical Device and Diagnostic Research team to uncover root causes and implement effective recruitment solutions.

A top medical device maker partnered with ICON to validate a new immune assay. The study aimed to collect serum samples from up to 760 U.S. patients with various thyroid and autoimmune conditions to demonstrate assay performance.

ICON supported five global IVD studies on rapid colorectal cancer diagnosis, enrolling over 29,000 patients across 250+ sites. Each study had unique needs, and ICON managed key functions including project management, monitoring, data handling, and site oversight.

As a result of the comprehensiveness of the documentation and the efficient management of the process, the European Commission granted both indication extension and the additional year of market exclusivity.

Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. ICON’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.

A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.