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.
Re-adjudicating a respiratory and cardiovascular trial during COVID-19
The FDA advised the trial to re-adjudicate so that the study accounted for the effects of COVID-19 on the trial outcomes. To ensure that the trial data would be submitted to the FDA as scheduled, ICON needed to coordinate re-adjudication of 700 endpoints within a compressed three-month timeline.
Automating EDC user access for improved trial efficiency
This case study demonstrates how ICON automated EDC user access management using API integrations and workflow automation, enhancing efficiency, security, compliance, and scalability in clinical trials while reducing costs and delays.
Safety reporting continuity to protect patient safety and maintain compliance
Scientists are working diligently to learn more about the Coronavirus and health boards are changing guidance to adapt to
this newly available information.
this newly available information.
Accelerating site proposal and selection
Timely patient recruitment is crucial to maintaining clinical trial timelines and budgets, but selecting the best and most engaged sites is challenging. Learn how ICON's proprietary One Search platform addresses this by aggregating and cleaning data from multiple sources.
The ICON safety reporting solution
ICON's Safety Reporting Solution ensured regulatory compliance during global trials by adapting to pandemic-related disruptions.
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.
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.