A leading medical device manufacturer developed an updated immune assay and engaged ICON with conducting a project to demonstrate adequate performance. The protocol was designed to acquire the necessary clinically characterized serum samples from up to 760 eligible subjects diagnosed with autoimmune thyroid diseases, non-autoimmune thyroid diseases and non-thyroid autoimmune diseases in the US.

The anticipated enrolment period for this study was approximately 22 months. Factors affecting enrolment included:

• Inclusion and exclusion criteria were very limiting
• Total of six protocol amendments (four within one year), respective IRB submissions and retraining of sites
• Sites declining participation during start up
• Subjects excluded after medical review

• ICON and client committed to realistic project timelines and developed mitigation strategies to achieve the enrolment target within the new timeline.
• A Site Management Associate (SMA) and a Clinical Trial Manager were onboarded to improve site communication.
• Site Engagement Liaisons (SELs) from ICON’s Patient Recruitment and Retention Service, were involved for 9 months to drive innovative end-to-end strategies for increased patient recruitment and engagement.
• CTM/SMA attended SEL calls and continued calls after termination of SEL.
• Virtual Investigator Meetings and coffee break out sessions were implemented by the Clinical Team and client.
• The ICON and client teams met regularly to review project and enrolment updates, discuss challenges and implement solutions, and review enrolment forecasting obtained from sites.

ICON implemented innovative strategies to promote consistency, transparency, and accountability throughout the process. This strategic approach enabled the successful and timely completion of both enrolment and delivery. The study effectively collected and characterized the required samples, supporting a robust statistical evaluation of the assay’s performance. Findings confirmed the assay’s sensitivity, specificity, and clinical utility, contributing to regulatory progress and product readiness. ICON’s well-executed strategy led to strong client satisfaction, as reflected in high Engage scores.