Clinical & scientific operations case studies

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.

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.

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 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.

This case study shows the effectiveness of this agile and forward-thinking approach to workforce scaling under time-
sensitive conditions.

A mid-size pharmaceutical company with numerous affiliates and local vendors across 80 countries sought a reliable partner for effective Pharmacovigilance (PV) and Medical Information (MI) services.

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.