Building Capacity for Health Research Innovation
Delivering decentralised research and trials in communities and homes where people live and work. A cost-effective, community-delivered model for innovation in the UK.
Sponsor Challenges with Existing Technology
Traditional site-only trials led to higher costs, participant burden, and dropout rates, with limited real-time data capabilities and cumbersome data management processes. Existing systems lacked capability for community-based and home-based recruitment, seamless eConsent, remote tracking, and automated workflows.
Modern Technology Introduced
Vibrent’s modern data stack, a no-code unified data platform that is proven at large scale of 1 Million participants across the US for multi-country, multi-site, longitudinal registries, studies and trials. Capabilities include inclusive recruitment, real-world data collection from participants, broader data integration and linkages, long-term participant engagement.
Where & How Technology is Deployed
Deployed across the United States in a hybrid decentralized, Phase 3 and 4 clinical trial sponsored by a leading pharmaceutical company. Delivered internet-based recruitment, remote eConsent, remote biosample collection (saliva, swabs, blood), and real-time data and site study dashboards to streamline trial operations and data management. Enabled remote eConsent, automated workflows for bio-sample collection and ePROs, advanced digital marketing, remote shipping/tracking of diagnostic kits, and real-time data analytics. Proven success in large-scale trials with the US. NIH demonstrated the platform’s scalability and reliability.
Goals of Implementing the New Technology
Create a new model for drug development. To rapidly recruit 6,500 participants from communities and homes, simplify remote biosample collection, ensure seamless data integration, and minimize participant burden by reducing site visits.
Reduce costs, accelerate recruitment, and improve data quality through hybrid decentralised clinical research models.
Impact Areas
Recruitment Speed
Achieved recruitment of 6,300 participants in 6 months, reducing activation time by 50%.
Retention
Simplified remote participation improved retention by 35%, preventing dropout losses of over $7M.
High Data Quality
Automated data harmonization reduced errors by 60%, ensuring higher accuracy for regulatory submissions.
Faster Decision-Making
Real-time analytics enabled 40% faster protocol adjustments, accelerating regulatory compliance.
Participant Experience
Simplified eConsent and automated workflows improved compliance and data completeness.
Regulatory Impact
Ensured compliance with HIPAA, GDPR, 21 CFR Part 11, NHS Cyber Essentials Plus, MHRA.
Time Efficiency Gains
- Recruitment Speed: Reduced from 18 to 6 months.
- Study coordinator and informatics staff Efficiency: Reduced CRC and IT staff time by 70%.
Reduce Participant Burden
- Simplified eConsent and biosample collection allowed participants to complete tasks remotely.
- Reduced need for site visits minimized participant burden, improving retention and data completeness.
Cost Savings
- Per-participant cost reduced: From $3,000 (site-based) to $500 (remote), saving $15.75 M.
- Remote Shipping Efficiency: Saved $150 per kit for 12,000 kits, totaling $1.8M.
Health Economic Impact
- Enabled faster decision-making for new indications through real-time analytics.
- Reduced on-site expenses enhanced financial sustainability for decentralized trials.
Clinical Research Impact
- Phase 3 and 4 trial achieved higher diversity and reached broader demographics, reducing dropout rates.
- Faster protocol adjustments and regulatory compliance.
Scalability & Future Enhancements
- Vibrent’s platform demonstrated scalability for additional decentralized trials across multiple therapeutic areas.
- Modular design allows rapid adaptation for other disease types beyond infectious diseases.
Lessons Learned
- High participant satisfaction and convenience.
- Reduced inequalities.
- Dramatically lower cost due to automated workflows and real-time analytics.
- Continuous participant engagement through personalized reminders improved retention.
- Efficient remote shipping/tracking reduced costs and streamlined logistics.
