All case studies

Highlights

We focus our innovation on the factors that matter most — accelerating time to market, reducing costs and enhancing quality. Learn more about how we've helped clients meet and exceed their goals in this selected library of case studies.

Proactive patient retention strategy in a GLP-1 RA trial

Explore how ICON successfully supported a sponsor’s cardiovascular outcome trial for a GLP-1 receptor agonist with 9,900+ patients with type 2 diabetes and maintained a retention rate of 97% over 7 years.

A small biotech success story

A small US-based biotech company was in a race to be the first to market with their lead targeted oncology product.

FSP partnership - sustained efficiency and ongoing innovation

The implementation of an FSP model across our partner's project management function, led to 20% cost efficiences and a 30% reduction in client burden.

By taking a site and patient-centric approach, and leveraging advanced tools and real-time data insights, we maximise patient access, recruitment, and retention—ensuring that every trial is conducted with efficiency, agility, and a commitment to improving patient outcomes.

All case studies

Filter our case studies by categories, selecting amongst our broad range of solutions.

Partnering to provide vital regional support on a global medical device study

ICON was selected as a European partner CRO for a drug-coated balloon device study, supporting regulatory services, study start up and monitoring activities, and safety reporting service for study sites located across Europe. The device consequently received CE Mark certification and FDA approval.

Meeting new REMS SPL guidelines 22 months before they became mandatory

A CRO managing a Shared System REMS engaged ICON Regulatory Consulting to support a Type V Drug Master File since 2016, covering four branded and 200 generic products. Following the FDA’s 2020 guidance on structured product labeling (SPL), ICON prepared the REMS SPL to meet the December 2022 compliance deadline.

Enabling US and EU market entry for neurodegenerative disease treatment

An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. ICON Regulatory Consulting was engaged to support market entry.

Ensuring consistent source data monitoring for a global cardiology study

This global, double-blind cardiology study evaluated an atrial shunt’s impact on quality of life and heart failure symptoms in 260 patients. Conducted over 4.5 years at 66 sites, it included a crossover option and five-year follow-up.

Collaborating to improve monitoring visit trip reports

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.

Resolving patient recruitment issues in an oncology study

A large multi-year IVD colorectal cancer study faced enrolment challenges across 180+ sites and 28,000 participants. The sponsor turned to ICON’s Medical Device and Diagnostic Research team to uncover root causes and implement effective recruitment solutions.

Immune assay for thyroid diseases

A top medical device maker partnered with ICON to validate a new immune assay. The study aimed to collect serum samples from up to 760 U.S. patients with various thyroid and autoimmune conditions to demonstrate assay performance.

Overcoming under-enrolment for an assay study on neonate sepsis

A two-year non-interventional study evaluated an interleukin assay for diagnosing neonatal sepsis. Over 500 samples were collected across 24 U.S. sites, using control and treatment cohorts to assess biomarker accuracy and diagnostic performance.

Optimising resources on a portfolio of large scale oncology studies

ICON supported five global IVD studies on rapid colorectal cancer diagnosis, enrolling over 29,000 patients across 250+ sites. Each study had unique needs, and ICON managed key functions including project management, monitoring, data handling, and site oversight.

Regulatory problem-solving secures crucial extensions in pediatrics and rare disease

As a result of the comprehensiveness of the documentation and the efficient management of the process, the European Commission granted both indication extension and the additional year of market exclusivity.

Regulatory solutions for uncharted scientific waters

Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. ICON’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.

Use of Real World Data to fulfil post-approval requirements

A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.

Solutions case studies

Our solutions span the entire lifecycle of product development and can be adapted to suit small local trials or large global programs. Explore our work in the different aspects of our solutions.

Let's collaborate

Discover how ICON's expertise transforms clinical trials.

Blogs

Stay informed with ICON's expert insights on clinical trials, regulatory changes, and industry trends. Our blogs provide practical advice, innovative solutions, and thought leadership from global experts.

News

Stay updated with our latest news on partnerships, financial results, technological advancements, and industry insights.

Insights

Explore ICON's expert analysis and practical advice on the latest operational, regulatory, technological and economic challenges in clinical research. Our insights provide thought leadership and innovative solutions to transform trials.

Case studies

Highlights

Proactive patient retention strategy in a GLP-1 RA trial

A small biotech success story

FSP partnership - sustained efficiency and ongoing innovation

All case studies

Partnering to provide vital regional support on a global medical device study

Meeting new REMS SPL guidelines 22 months before they became mandatory

Enabling US and EU market entry for neurodegenerative disease treatment

Ensuring consistent source data monitoring for a global cardiology study

Collaborating to improve monitoring visit trip reports

Resolving patient recruitment issues in an oncology study

Immune assay for thyroid diseases

Overcoming under-enrolment for an assay study on neonate sepsis

Optimising resources on a portfolio of large scale oncology studies

Regulatory problem-solving secures crucial extensions in pediatrics and rare disease

Regulatory solutions for uncharted scientific waters

Use of Real World Data to fulfil post-approval requirements

Solutions case studies

Let's collaborate

Blogs

News

Insights