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 prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. Quality imaging data from multiple sources was critical to the study’s success and ICON helped manage the imaging data for each participant.

Despite effective treatments, osteoporosis still needs better, affordable options. A sponsor ran a 3-arm, double-blind study on a denosumab biosimilar in 225 healthy men over 10 months at two ICON sites.

In 2023, a leading China-based biotech firm partnered with ICON to launch a global programme for a key asset. Building on a six-year strategic alliance and success in China, the client expanded into the US and Europe, prioritizing efficiency and cost control. ICON deployed a blended model—FSP in China and the US, and full-service support in Europe — to align with regional needs and strategic goals.

This case study highlights the strategic execution of an Expanded Access Program (EAP) across multiple global regions, Europe, Asia-Pacific, and Latin America, following a Phase 3 clinical study.

During the peak of the COVID-19 pandemic, a global compassionate use program (CUP) was urgently needed to provide compassionate use of a promising treatment. The program required rapid deployment across multiple regions to support hospitalized patients.

To ensure continuity of care for participants in the maintenance phase of multiple parent studies in oncology managed by ICON and third-party vendors, a consolidated long-term extension (LTE) protocol was required.

An oncology study involving 53 parent protocols - each with distinct timelines, sites, databases, and reporting requirements - needed to be integrated into a single open-label extension (OLE) study.

An established customer sought to streamline patient follow-up across multiple clinical protocols, each involving different sponsors and assets, to support ongoing treatment and safety data collection.

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.

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.