The Benefits of an End-to-End Wearable Sensor CRO Partnership: Real Data Showing Real Progress
In the evolving landscape of clinical trials, digital health technologies (DHTs) and wearable sensors are no longer optional; they’re essential. At the 2025 Digital Biomarkers Summit, argenx and VivoSense showcased a compelling case study that highlights the transformative power of an end-to-end partnership between a pharmaceutical company and a wearable sensor CRO.
View the full presentation here:
From Fragmentation to Integration
argenx’s initial foray into digital measures was marked by fragmented efforts and misaligned strategies. Recognizing the need for a cohesive approach, they established a DHT CORE team and partnered with VivoSense to act as their dedicated Wearable Sensor CRO. This strategic shift embedded digital into the company’s DNA, enabling tailored solutions at the indication level and delivering value beyond regulatory labels, especially for patients and caregivers.
The Power of End-to-End Support
VivoSense’s role as a wearable sensor CRO spans the entire clinical trial lifecycle:
- – Study Startup: Strategy development, measure selection, and protocol design.
- – Study Conduct: Operationalization, monitoring, and data collection.
- – Study Closeout: Statistical analysis and clinical validation.
This comprehensive support ensures that digital endpoints are not only scientifically robust but also regulatory-ready.
Real-World Impact: Data That Speaks
The partnership yielded impressive results across multiple studies:
- – In a Phase 3b open-label study, VivoSense achieved a 95.3% rate of valid data days. This demonstrated a profound improvement when compared to a previous Phase 2 study, which achieved a 54.82% rate of valid data days when VivoSense operational oversight was not included.
- – Real-world actigraphy measures demonstrated large effect sizes, outperforming traditional clinical outcomes.
- – “Best Natural Effort” digital measures, capturing peak activity periods, proved more sensitive to change and better correlated with muscle weakness and functional limitations.
These insights underscore the value of continuous feedback loops, operational oversight, and proactive issue tracking, all of which enhance data quality and completeness.
Strategic Alignment and Regulatory Readiness
The collaboration also emphasized early planning for regulatory interactions, particularly in rare and ultra-rare indications. By aligning digital strategies across multiple programs and engaging regulators early, argenx and VivoSense accelerated timelines and strengthened their case for digital endpoints.
A Blueprint for the Future
This case study offers a blueprint for other pharmaceutical companies and CROs:
- – Co-create strategies with expert partners.
- – Plan early for regulatory engagement.
- – Leverage real-world data to capture meaningful patient outcomes.
- – Invest in end-to-end partnerships to unlock the full value of digital measures.
As the industry moves toward more patient-centric and data-driven trials, the argenx-VivoSense collaboration stands as a testament to what’s possible when science, strategy, and technology converge.
Watch the entire presentation here