Device Management in Clinical Trials: When Everyone Owns It, No One Does

In last week’s post on Digital Readiness, we explored why giving teams access and training isn’t enough. Clinical technology doesn’t work unless the people expected to use it are prepared. But readiness isn’t just about the team. It’s also about what happens when those tools have a physical element to them.

Tablets are now embedded in trial workflows: used for digital screening, real-time symptom reporting, participant questionnaires, and site data entry. But the one question that keeps showing up and rarely gets answered is this:

Who’s responsible for keeping the tablets connected, configured, and functional?

More often than not, the answer is... unclear:

• Sponsors expect vendors to manage it
• Vendors expect sites to “handle it” locally
• CROs assume it’s just part of the setup
• Sites are left troubleshooting mid-visit or paying for local IT support themselves

Everyone assumes someone else is covering it until something breaks. And when no one truly owns device management, the consequences show up fast:

• Missed or delayed assessments due to device failure 📉
• Sync issues that go undetected until it’s too late 🔄
• Site burden, confusion, and unplanned workarounds 😓
• Audit gaps from missing documentation or inconsistent device logs 📋

The common assumption is that managing devices is passive, when – in fact – it’s active, ongoing work.

Here’s what it actually involves:

🔧 Initial configuration

• Mobile Device Management (MDM) / Security app installation
• Device accounts and permissions

🌐 Connectivity setup

• Wi-Fi and/or wireless carrier access
• VPN or roaming support
• Navigation of site-level network restrictions (firewall, MAC filters, etc.)

🔄 Ongoing support

• OS updates and app version control
• Battery issues, lockouts, failed syncs
• Replacement coordination and device resets

🧾 Documentation & compliance

• Device ID tracking and audit trails
• Chain of custody or location-based logs

This is infrastructure. It needs ownership. And when it’s not defined, the gaps create real operational risk. Getting ahead of this means planning for device management at the study design stage, not treating it as a post-launch fire drill. That includes:

• Making device planning part of the study design and clinical operations plan – not just the procurement checklist
• Clarifying roles across sponsor, vendor, CRO, and site
• Aligning on whether local IT support is needed and who funds it
• Establishing clear escalation paths and response timelines
• Including SOPs for mid-study updates or replacements

Most tablets don’t fail for sites because of damage or defects. They fail because the responsibility for keeping them functional was never clearly assigned. If digital readiness is about preparing teams to use tools, then device management is about preparing those tools and sustaining them once they’re in the field.

Not sure who should own device setup, support, or escalation in your trial? Let’s make it clear before it becomes a problem.

Schedule a free consultation to build device accountability into your study plan with Unifora.‍