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.
On-demand Medical Writing solution
A mid-sized, global biopharmaceutical company specialising in rare diseases and neurodegenerative disorders,
including ALS and Parkinson’s, needed a scalable cost-effective solution to manage periodic surges in medical
writing demand. The company maintains a global workforce of over 5,000 employees and utilises an embedded
ICON FSP medical writing team of five to support its portfolio.
including ALS and Parkinson’s, needed a scalable cost-effective solution to manage periodic surges in medical
writing demand. The company maintains a global workforce of over 5,000 employees and utilises an embedded
ICON FSP medical writing team of five to support its portfolio.
Expanding Biometrics and Data Management capabilities in India within mid-size pharma
This case study explores how a sponsor partnered with ICON to scale biometrics and data management in India, achieving rapid growth, cost efficiencies, and seamless global delivery.
Driving data excellence across a global R&D portfolio
A large global pharmaceutical sponsor engaged ICON to stabilise, modernise, and scale Clinical Data Science (CDS) delivery across more than 90 active studies.
Transforming post-marketing safety operations
ICON partnered with a top 10 global pharmaceutical company to support its post-marketing pharmacovigilance
(PV) operations. The partnership evolved from a traditional service model into a fully embedded, strategic
collaboration focused on continuous improvement, cost savings, and global harmonisation.
(PV) operations. The partnership evolved from a traditional service model into a fully embedded, strategic
collaboration focused on continuous improvement, cost savings, and global harmonisation.
Scaling safety operations for a first-in-market launch
ICON partnered with a leading BioPharma company to support pharmacovigilance (PV) operations for a novel indication product. Following six years of collaboration during clinical development, ICON transitioned to post-marketing support upon product approval and launch in the US and EU.
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.