When Technology Becomes a Barrier, Smart Device Management is the solution
Electronic data capture through eDiaries is a proven tool for improving patient-reported outcomes and real-time symptom tracking in clinical trials. However, in many decentralized or hybrid studies, particularly those involving underserved or rural populations, a critical issue arises: not all participants have access to the mobile devices or internet connectivity required for consistent data entry.
This digital divide threatens data quality, increases protocol deviations, and places an operational burden on sites. For sponsors and CROs aiming to uphold the integrity and equity of their research, solving this problem is no longer optional — it’s essential.
The Real Challenge: Ensuring Adherence Without Device Access
Clinical teams often improvise when participants lack compatible smartphones or data plans. Without proper infrastructure, the risk of missed entries, inaccurate data, and regulatory setbacks increases dramatically.
Beyond affecting compliance, these gaps can undermine study outcomes, especially when symptom data is time-sensitive or used for primary endpoints.
The Solution: Centralized and Scalable Smart Device Management
To address this challenge head-on, Integra IT has developed a comprehensive device management service tailored to the demands of modern clinical trials.
Our approach includes:
- Provision of preconfigured smartphones for eDiary use, delivered directly to research sites
- Monthly internet top-ups for participants who lack connectivity
- Centralized inventory control, with full traceability per device and site
- Real-time usage monitoring via automated dashboards
- Technical support (5×8 or 7×8 coverage)
- Management of logistics, collection, and secure disposal post-study
This model complies with regulatory expectations (FDA 21 CFR Part 11, ICH GCP) and is designed to scale across multicenter and multinational studies.
Case in Point: High eDiary Compliance in Remote Latin American Sites usign Smart Device Management
In a recent decentralized study conducted across rural sites in Latin America, 40% of participants lacked access to a suitable smartphone, and over 70% had no mobile internet.
Thanks to our device management service:
- Sites received preconfigured smartphones with secure apps installed
- Monthly data plans were activated for each participant
- Site staff could track compliance through centralized dashboards
- Adherence to daily eDiary completion remained consistently above 90%
Key Benefits for Sponsors and CROs
- High-quality, real-time patient data
- Reduced site workload and fewer deviations
- Improved participant engagement, even in low-resource settings
- Regulatory readiness with complete device traceability
- Lower risk of loss or misuse through controlled logistics
Next Step: Equip Your Study for Real-World Conditions
Are limited device access or internet coverage impacting your study performance?
Let’s talk. Discover how an innovative, patient-centered device management strategy can transform your trial’s efficiency and compliance.
