What Sets Us Apart

• Diagnostics & Devices First – We’re built for IVDs, medical devices, and AI-enabled technologies and not repurposed from pharma.
• Lean & High-Touch – You work directly with senior experts, not layers of bureaucracy.
• Faster Site Start-Up – Powered by real-world prevalence data and curated investigator networks.
• Transparent Oversight – Live dashboards and proactive communication keep you informed at every step.

Connected for Speed and Scale

• Curated Site Network – Investigators pre-qualified for diagnostic and device studies.
• Biospecimen Core Labs – Established partnerships with biospecimen vendors and CLIA/CAP-certified labs.
• Advanced Technology – CTMS/EDC, real-time dashboards, and AI-driven site selection.
• Expert Site Training – Proven programs to ensure protocol compliance and data quality.

Regulatory Readiness, From Day One

• Full compliance with FDA 21 CFR 812, 809, 50, 56 and ICH E6(R3).
• IDE, 510(k), PMA, and De Novo pathway expertise.
• Inspection-readiness baked into every study (GCP, ALCOA+ documentation).
• Seamless TMF/ISF management to support submissions and audits.

• Diagnostics demand speed, precision, and regulatory clarity. Every study we design reflects those realities.
• At Dynamill, we stay agile and hands-on. We work as an extension of your team focused not just on getting trials done, but on getting them done right.
• No bureaucracy. No delays. Just smart, lean execution that moves your innovation forward.