ICON supported a proof-of-concept real-world study for participants experiencing bothersome vasomotor symptoms (VMS). The hybrid decentralised clinical trial (DCT) model included both on-site and remote visits, enrolling approximately 1,000 participants across the United States. The study aimed to reduce overall participant burden while collecting electronic patient-reported outcomes (ePROs), diary entries, and activity data remotely.

The study required consistent data capture across multiple modalities, including actigraphy, ePROs, and eDiaries. Ensuring compliance with remote data collection tools while maintaining participant engagement posed a challenge, particularly given the need for daily monitoring, collection of actigraphy wear periods, and participants’ ability to recall of the number of hot flashes throughout the day

In partnership with the sponsor, ICON deployed a comprehensive digital health strategy, including the use of actigraphy watches to collect activity, sleep patterns, and heart rate data. The Concierge Services team provided support to study sites and direct outreach to patients to enable telehealth visits, eConsent, and remote collection of critical ePRO and eDiary data. ICON’s digital risk detection tools strengthened endpoint data capture through daily non-compliance tracking, streamlined ticketing and escalation processes, revised call scripts, frequent data reviews, collaborative scrums, and targeted site retraining

The study achieved strong compliance across all digital endpoints, with over 90% ePRO compliance, more than 80% actigraphy wear compliance, and over 75% eDiary compliance. These results demonstrate the effectiveness of ICON’s hybrid DCT model, supported by Concierge Services direct-to-patient outreach in reducing participant burden while maintaining high-quality data