Therapeutics case studies

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.

A leading multinational pharmaceutical company partnered with ICON to conduct a phase 1 obesity study assessing the safety and tolerability of a new investigational oral amycretin therapy.

ICON was once again selected as a partner to conduct a phase 1 study in individuals who are overweight or have obesity, evaluating the safety and tolerability of a new subcutaneous GLP-1 and amylin peptide formulation.

A large pharmaceutical company was conducting a Phase 2 study for adults with a BMI of 18-32. They contracted 60 US sites, including 9 Accellacare sites to recruit for two cohorts and conduct the study.

A medical device developer faced clinical evaluation timeline delays due to under-enrolment. Discover how the collaborative partnership between the sponsor and ICON’s Medical Device & Diagnostics Research team steered the study from patient enrolment to FDA submission and approval.

A pharmaceutical sponsor launched a global trial for elderly UTI patients, opening 125 sites across 15 countries. Enrolment lagged at 1 patient per site per month, with 70% non-enrolling. ICON was brought in to rescue the study.