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.

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.

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.

Custom FSP+ model drives sponsor success

A Top 10 biopharma company aimed to expand trials across CEE, including new markets. ICON delivered a custom model combining full operational ownership with local expertise and embedded governance to ensure consistency in a global, multi-vendor FSP setup.

Overcoming time zone and knowledge gaps to gain FDA IND study approval

A Europe-based biotech preparing for a phase 1/2a oncology trial turned to ICON for support during their first IND submission. With limited FDA experience, they relied on ICON to navigate the 30-day review period and respond quickly to agency requests.

Seamless transition to Functional Service Provider for medical writing

Outsourcing to an FSP often raises concerns about control, visibility, and quality. When a top-20 pharma company partnered with ICON for medical writing, ICON’s tailored approach ensured a smooth transition without sacrificing oversight or standards—building a strong, lasting partnership.

CMC and local regulatory expertise deliver timely anti-cancer drug approval

An international biopharmaceutical company based in the EU contracted ICON to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration.

Overcoming enrollment challenges in an early phase obesity trial

A leading multinational pharmaceutical company partnered with ICON to conduct a phase 1 obesity study assessing the safety and tolerability of a new investigational oral amycretin therapy.

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

Collaborating to improve monitoring visit trip reports

Resolving patient recruitment issues in an oncology study

Immune assay for thyroid diseases

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

Custom FSP+ model drives sponsor success

Overcoming time zone and knowledge gaps to gain FDA IND study approval

Seamless transition to Functional Service Provider for medical writing

CMC and local regulatory expertise deliver timely anti-cancer drug approval

Overcoming enrollment challenges in an early phase obesity trial

Solutions case studies

Let's collaborate

Blogs

News

Insights