Fast-track country and site approvals. Gain back valuable time.
Leave IRB/IEC submission package creation to our experienced team with our turnkey Ethics Committee Submission Package Service. We’re committed to delivering accurate, submission-ready packages—fast, and with uncompromising quality.
Accelerate Submissions without Sacrificing Quality
We deliver high-quality, IRB/IEC-ready submission packages on time, every time. Whether you’re racing to meet tight deadlines or navigating complex regulatory requirements, we help ensure your study timelines stay on track by preventing delays caused by incomplete or inaccurate submissions.
Platform-agnostic Expertise
With hands-on experience across 10+ leading eClinical platforms, we tailor our approach to fit your unique platform configuration. Our platform-agnostic capabilities allow us to leverage best practices and optimize deliverables, no matter your tech stack.
Scalable to Your Needs
Our flexible model scales with your demands, from a single study to an entire portfolio. Backed by a seasoned team and proven processes, we consistently deliver high-quality submission packages with the speed and accuracy your studies require.
Reduce Internal Burden
IRB/IEC submission packages are complex, time-consuming, and detail-heavy. Let us handle the heavy lifting so your internal teams can focus on strategic site onboarding activities. Our proven processes reduce rework, minimize risk of delays, and ensure first-time-right submissions.
Built-In Compliance and Quality
Compliance is non-negotiable. That’s why every package goes through mandatory Quality Assurance checks to ensure exceptional accuracy. From screenshots and patient training materials to device labels and global certificates of translation, we deliver submission packages that are audit-ready and aligned with all regulatory expectations.
1200+
Clinical Trials
Studion has supported over 1,200 clinical trials by delivering scalable, compliant, and patient-centric digital health solutions.