Clinical & scientific operations case studies
How we provide innovative solutions to ensure accurate data, regulatory compliance, and patient safety
Maximising patient recruitment and retention, and expanding access to diverse patient populations.
We work with you to develop strategic, flexible approaches that leverage clinical informatics, state-of-the-art technologies, and our global reach to make data-driven decisions for every study.
Transitioning from a Phase 3 study to an EAP
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.
Rapid deployment of a compassionate use program
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.
Consolidation of multiple protocols into a single LTE oncology study
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.
Integration of multiple oncology studies into a single OLE study
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.
From early engagement to award
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.
Accelerating study start-up through standardised IRT Integration
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.
start-up and cutting costs through the standardisation of IRT integration across programmes.
Strategic expansion of Clinical Operations support and TMF hub
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.
From targeted engagement to global, multi-functional collaboration
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.
Streamlining clinical operations
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.
Accelerating team growth to support client demand
This case study shows the effectiveness of this agile and forward-thinking approach to workforce scaling under time-
sensitive conditions.
sensitive conditions.
Affiliate level solution
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.
Eliminating enrolment delays to bring an AI-enabled SaMD to market
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.