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.
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.
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.
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.
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.