Clinical & scientific operations case studies

Resolving critical issues and ensuring trial integrity

ICON implemented a Data Management Asset Lead (DMAL) role to provide oversight and ensure adherence to standards for a sponsor with limited bandwidth.

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.

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.

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.

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.

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.

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.

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.

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.

A top-tier pharma company partnered with ICON to harmonize legacy data from 11 oncology studies into CDISC standards, resolving non-compliance issues.

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.