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.
Global remote monitoring CRA hub
A complex oncology study in multiple myeloma cancer experienced a 30% higher than anticipated enrollment rate, leading to a large data backlog. Learn how ICON implemented global remote monitoring to address the backlog and manage ongoing data volume.
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.
Examining approved adult drugs for kidney disease in children
A pharmaceutical company faced significant delays in its pediatric program, particularly in recruiting younger age groups, putting the study at risk. After missing multiple deadlines, the sponsor turned to ICON’s Centre for Paediatric Clinical Development for a strategic review, which resolved recruitment challenges and aligned the program with U.S. and European regulatory guidance.
Integrating safety and efficacy data for submission analysis
A top-tier pharma company partnered with ICON to harmonize legacy data from 11 oncology studies into CDISC standards, resolving non-compliance issues.
Collaborative approach to advance early phase breast cancer research
A biopharma company partnered with ICON to conduct a phase 1/2 study on breast cancer, overcoming challenges related to regulatory compliance, tight timelines, and data integrity through strategic statistical analysis.
Streamlining non-CDISC decentralised trial data analysis and reporting
A pharma company conducted a phase 2 DCT, and faced challenges with non-standardised data and shifting priorities, which ICON addressed by collaborating with the data vendor to standardize data transfers and using a metadata-driven approach to streamline statistical analysis.