Case studies
Working with our customers to reduce time to market, deliver on quality, provide deep therapeutic expertise, and enhance R&D ROI.
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
Select amongst our broad range of solutions and experience.
Flexible, robust and rapid IRT solution for an international infectious disease trial
ICON was tasked with providing a rapid and flexible IRT solution for a multinational infectious disease vaccine trial with over 30,000 subjects in 100+ locations.
Prioritising efficiency and flexibility in safety data signal detection
ICON collaborated with a small US-based pharmaceutical company to conduct safety signal detection and management during the clinical development of four neurodegenerative disease compounds, using SIGNET.
Effective collaboration on clinical data standards governance
ICON's Global Data Standards team helped a large pharmaceutical company consolidate multiple standards libraries into a single, harmonized library used across therapeutic areas.
ICON implements new Lay Protocol Synopsis (LPS) program
Increased trial transparency has been a growing industry trend for many years. The largest recent initiative in this realm
is the European Medicines Agency’s (EMA’s) Clinical Trials Information System (CTIS), which went online in January
2022.
is the European Medicines Agency’s (EMA’s) Clinical Trials Information System (CTIS), which went online in January
2022.
IRT User Acceptance Testing
Resolving critical issues and ensuring trial integrity
Evolving quality oversight to limit sponsor burden
ICON implemented a Data Management Asset Lead (DMAL) role to provide oversight and ensure adherence to standards for a sponsor with limited bandwidth.
Applying statistical and programming expertise to overcome FDA challenges
ICON supported a biotech company in preparing for FDA submission by quickly mobilising a team to address unexpected comments on statistical analysis and data collection, resulting in timely BLA submission, enhanced data quality, and alignment with FDA requirements.
The importance of CRF design in cell and gene therapy studies
ICON partnered with a biotech sponsor to optimise Case Report Forms (CRFs) for an oncology cell and gene therapy trial. By adopting iRECIST criteria and standardising CRF templates, we reduced data duplication, ensured accuracy, and provided flexibility for subject re-treatment.
CRF design for a cell-therapy, immuno-oncology study
ICON developed flexible, cost-effective CRF designs for a cell therapy immuno-oncology study, harmonising RECIST and iRECIST criteria while addressing re-treatment requirements and supporting sponsors in meeting study timelines.
Optimised adaptive trial design for oncology biotech
ICON assisted a US-based oncology biotech in overcoming timeline, data uncertainty, budget constraints, and pressure for publishable results by offering a cost-effective phase 3 trial design with interim analysis, enabling early efficacy and regulatory approval with minimal upfront investment.
Comprehensive standalone DMC services
ICON provided a comprehensive DMC solution for a phase 2 NASH trial, overcoming challenges like coordinating data across multiple vendors and adjusting to rapid enrollment.
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Quantitative risk assessments to meet regulatory submission requirements
ICON provided a tailored quantitative risk assessment solution to help a sponsor anonymize clinical study data and documents for regulatory submission and private data-sharing.
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Discover how ICON's expertise transforms clinical trials.