Medical Device Clinical Trials Unit (MDCTU)

Introduction

The Medical Device Clinical Trials Unit (MDCTU) provides comprehensive and well-coordinated research services for pediatric medical device innovators in industry and academia. We can support projects across the entire product life cycle, with a special focus on discovery, clinical trials, and real-world data. With our access to expert medical providers and diverse pediatric populations, we aim to transform pediatric care and save lives through research and innovation.

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Supported activities

Regulatory Strategy

Pathway to market; Device classification; Breakthrough Device Program and Safer Technologies Program

Clinical Strategy

Feasibility assessment; Clinical study design; Site selection; PI engagement; Study populations identification

Medical Writing

Protocol development; Consent forms; Investigator Brochure; IRB application; Drafting budgets and contracts

FDA Engagement

Facilitate official and unofficial meetings with the regulatory agency

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Contact us if you are

• Looking for professional guidance in pediatric medical device development
• Pursuing pediatric indication for your current product, but hesitant due to regulatory considerations
• Wanting to conduct a clinical study with children but don’t have a connection to medical centers with qualified staff
• Seeking a one-stop-shop to expedite pediatric medical device development
  

Join our team

Thank you for your interest in joining our team. While we currently do not have any open positions, we encourage you to check back regularly for updates. We look forward to the possibility of working together in the future!

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Contact us

Have any other questions? Please email us at info@ctipmedtech.org and we will be in touch as soon as possible.