Flexible, robust and rapid IRT solution for an international infectious disease trial

ICON was tasked with providing IRT services on a vaccine trial for an infectious disease. The multi-national trial included a patient population of over 30,000 subjects in over 100 locations, presenting technical, practical and logistical challenges. 

Timelines required for study set up were very short with a need for the IRT system to be built within four weeks. This presented challenges in relation to timeline and resource management, whilst developing a custom solution for sites and study users to manage multi-dose vials of investigational product with strict stability concerns.

The priority for the ICON Interactive Response Technology (IRT) group was to ensure best-in-class design and technical software solutions tosupport the trial via our  proprietary IRT solution - FLEX ADVANTAGE. The ICON IRT team rapidly engaged with the clinical team and sponsor to design a bespoke solution to ensure that patient randomisation and investigational product (IP) management worked seamlessly for this important trial. 

Focusing on the goal to provide a system capable of meeting the sponsor needs and the substantial enrolment target of 30,000 subjects, ICON IRT focused on a number of critical areas to achieve success: 

1. Flexible design and Agile SDLC (software development life cycle): Using an agile approach to system design and development, ICON IRT worked efficiently through the requirements process whilst accommodating protocol changes
   throughout. Final protocol changes were accommodated as late as two days prior to the completion of development. 
2. Robust and powerful system performance: ICON took proactive measures to optimise and enhance system performance. This included stress testing the system to simulate real-world scenarios and closely monitoring server load and CPU usage daily during the enrolment period. These steps ensured the IRT platform could cope, without interruption, with substantial volume of subject enrolment concurrently. 
3. Rapid data collection: ICON implemented a data integration to ensure IRT data was integrated with the electronic case report form to ensure efficiency at clinical sites. This reduced the need for duplicate data entry for the clinical site personnel
   while allowing real-time access to data in a single data set. 
4. 24/7 Site and systems support: ICON IRT offers an in-house staffed 24/7 support team for all IRT solutions. This service was critical for a fast-enroling trial such as this and required acute attention and subject matter expertise by the support team. To ensure support availability, the team availability was adjusted to ensure dedicated team members were available day and
   night to support urgent items including data changes.

ICON’s IRT expertise, technical capability and flexibility, ensured this multinational trial was set up within 4 weeks and ensured the IRT platform was robust enough to manage the substantial enrolment target of 30,000 subjects within weeks.

Living our mission of improving and saving lives, ICON IRT focused on the client’s ultimate need for quick enrolment and delivered a solution that ensured the protocol’s success. Several key factors played a successful role, including a focus on flexible design, system performance, rapid data collection and availability, and dedicated system support.