Leveraging a Virtual Site to Boost Diversity and Enrollment

Client Challenge

The client’s goal was to assess the sensitivity and specificity of a novel diagnostic test for colorectal cancer (CRC) in a large population representative of the diversity in the US. This study was prospective, cross-sectional, and multi-center. The client expected to enroll approximately 12,500 patients to ensure at least 60 pathologically confirmed CRC cases with a valid stool DNA test.

The client was looking for a solution that supported all stages of the study, facilitated patient enrollment, and offered patients convenient way to engage at every stage of the study. The ideal solution would also allow easy electronic data capture (EDC) data integration.

Our Approach

Alira Health delivered the only virtual site for diverse, decentralized patient enrollment and prospective screening. The solution was based on Alira Health’s platform, Health Storylines™, a disease-agnostic, customizable platform that connects healthcare stakeholders to engaged patients and to the data they require to make informed decisions.

Alira Health’s solution included the following key features:

• User-friendly interface for study enrollment and onboarding, including eConsent
• Identity verification to compare participants’ information against a national database
• Call center to manage, track, and report interactions with patients and HCPs and answer questions about payments and questionnaires
• Real-time study management platform that included patient monitoring dashboards, alerts, adverse event (AE) monitoring, IP delivery setup, and data transfer modules
• Integration with an EDC system used to store clinical data
• Outcomes

Outcomes

Working with the company, Alira Health successfully launched a virtual site to enroll patients for the clinical validation of a stool DNA test for Colorectal Cancer (CRC) Screening. The virtual-only approach allowed the client to expand CRC screening access and engage patients at every stage of the study.

The client recruited 20,000+ patients. 1,200+ patients enrolled in the study and engaged through Alira Health’s platform, Health Storylines.

Key Success Factors

The excellent patient experience was vital for the project’s success. eConsent, convenient enrollment and onboarding, smart notifications, and instant payments allowed the company to recruit and stay engaged with patients throughout the study.

The client was also able to manage the study actively thanks to the real-time study management suite of tools. 

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