A biotech company contracted ICON to conduct a large phase 3 study in Cell Gene Therapy (CGT) involving 532 patients. The sponsor needed support in reaching their goals for the study, including employing an efficient workflow for biopsy sampling and improving site compliance. It was agreed that a hybrid decentralised clinical trial would be suitable for the characteristics of the study. 10%increase in operational efficiency was also seen across this study.

The primary challenge in this trial was that the study needed to be conducted effectively and efficiently within strict timelines. ICON had to accelerate the screening and enrolment process to complete the study’s initial screening so that patients could begin treatment within just four days.

Another challenge to the success of this trial was the high expense of CGT treatments. The team had to identify creative solutions for reducing the site and patient burden within the assigned budget.

ICON developed an automated data flow process that supported the movement, review and processing of data in real-time. Automating this process eliminated any potential lag in the data flow to support the fast pace of the trial. The ICON Digital Platform — first generation, a fit-for-purpose technology solution, was deployed to connect, collate and provide integrated quality data for all service components including: visit scheduling, biopsy adjudication (including automated and seamless chain of custody or biopsy samples), IVRS, central adjudication, ePRO, eConsent, EDC and courier service logistics.

ICON managed to exceed sponsor goals on a number of different fronts. With automated workflows and a centralised management system, 100% of visits were completed with all biopsies successfully collated and processed. 2,600 ePROs were collected with complete compliance and all adjudication was completed within three days. In addition, patient enrolment exceeded the projected rates by seven months, and we achieved a 15-day median screening time within a 30 day window.