At TOBB ETÜ Hospital, clinical research is an integral part of our academic mission. As a university hospital, we combine clinical practice with scientific inquiry to advance medical knowledge and improve patient outcomes. Our research team works in compliance with international ethical standards and regulatory requirements.
1. Clinical Research and Trial Management
We conduct ethically approved clinical trials with full patient coordination and protocol development, ensuring the highest standards of safety and scientific integrity.
2. International Certification Support
We provide comprehensive support for FDA Clearance, CE Certification, and EU MDR (2017/745) compliance documentation for medical device companies.
3. Clinical Data Generation and Analysis
Our team collects and analyzes safety and efficacy data required for regulatory approvals, providing reliable and scientifically rigorous results.
4. Regulatory Consulting Services
We offer expert guidance on technical documentation, regulatory audits, and market entry strategies for healthcare and medical device companies.
5. Post-Market Surveillance & Clinical Follow-Up
We conduct post-market safety monitoring and real-world data analysis to ensure ongoing compliance and patient safety after market entry.
6. Collaborative R&D
We maintain an active research collaboration with TOBB ETÜ Engineering Faculty, creating a unique ecosystem where medical and engineering expertise meet to drive innovation.
7. Education & Workshops
We offer training programs, workshops, and webinars for healthcare professionals and medical technology companies on clinical research methodology and regulatory processes.