Therapeutics case studies

A medical device developer conducting a study to improve their current FDA-cleared ECG monitor application encountered participant enrolment issues that were overcome through collaboration and communication.

A major Point of Care (PoC) Publisher partnered with Symphony Health to evaluate an unbranded cardiovascular treatment campaign targeting hospital-affiliated physicians nationwide. The campaign used printed condition guides to engage HCPs and patients during key decision-making moments.

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 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 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.

The FDA advised the trial to re-adjudicate so that the study accounted for the effects of COVID-19 on the trial outcomes. To ensure that the trial data would be submitted to the FDA as scheduled, ICON needed to coordinate re-adjudication of 700 endpoints within a compressed three-month timeline.

ICON was engaged to support phase 2 study in patients with heartfailure and impaired systolic function. ICON’s proactive approach ensured the successful delivery of this complex study and enabled the client to make key strategic program decisions to advance their larger phase 2 trial.

A digital health lead at a large pharmaceutical company came to ICON Outcome Measures to find a wearable that could capture continuous cardiac rhythms and be used to detect QT prolongation.

ICON was approached by a large pharmaceutical company to conduct a fully decentralised placebo-controlled trial, focused
on demonstrating that the drug reduced symptom burden in patients with heart failure.

Four studies were awarded by a pharma organisation over a period of less than two years, with overlapping
start-up through close out timelines. Milestone expectations were aggressive, requiring an innovative approach and rapid start-up.

A 10-year existing FSO partnership was expanded to incorporate a blended model to aid sourcing niche roles across multiple geographies whilst the sponsor maintained greater control of key areas.