Quality and Compliance
Quality
Working with competent authorities for the specific studies.
EUDAMED ready under MDR (EU) 2017/745 and IVDR (EU) 2017/746, and CTR (EU) 536/2014 and CTIS compliant.
- Efficient Registration Support
- Timely Clinical Investigation Submissions
- Protocol Updates and Amendments
- Vigilance and Post-Market Surveillance Reporting
- Data Integrity and Transparency
Working with Clinical Trials Regulation (CTRs) under current standards by the European Commission.
Compliance
We guarantee full compliance with global regulatory standards, including FDA, MDR/CTR (EU), ISO 14155, ICH Guidelines, and more – so your clinical investigations run smoothly and efficiently.
- Ensures consistency and accuracy of documentation
- Simplifies translation and localization of content
- Provides a centralized repository for all documentation
A comprehensive Clinical Investigation Report (CIR), evaluating the safety and performance of the investigational product.
- In accordance with the ISO14155 for GCP to protect the rights, safety and wellbeing of human subjects in clinical trials.
- Providing clinical evidence supporting the device’s intended purpose, risk-benefit profile, and usability.
Medical Monitoring, ensuring safety and well-being of the study participants.
- Reviewing and assessing adverse events (AEs) and serious adverse events (SAEs), to determine causality and severity.
- Adherence to the clinical trial protocol, GCP, and regulatory requirements.
- Identifying and mitigating potential risk to participants.
Let’s Discuss Your Trial Today!
Contact GCRI to learn more about our clinical research services and how we can help you accelerate your innovations.