Clinical trials in compliance with EN540 regulations and ISO 14155 standards are performed to assess device performance, possible secondary effects and risk acceptability. These studies are required for implantables, Class III and some Class 2b devices. Studies may be conducted according to Good Clinical Practices (GCP) and Internal Conference of Harmonization (ICH). Clinical trials are conducted through Biomatech, NAMSA's European laboratory.
Capabilities include:
- Bibliography analysis and retrospective studies to analyze clinical data already available
- Prospective studies to assess device performance and safety, possible secondary effects and risk acceptability: trial design, study center recruitment, monitoring
- Clinical risk analysis and management for innovative materials, new designs and new therapeutic concepts
- Medico-economic data evaluation for device reimbursement
- Assistance in regulatory submissions to competent authorities
- Regulatory consulting
- Clinical investigation plan and final report preparation
- Selection of investigators, investigation sites, study monitoring and inspection
- Development of the Investigator brochure and interface with physicians and hospitals
- Design of Case Report Form (CRF)
- Interaction with ethical committee
- Data management, result evaluation and statistical analysis
- Clinical Risk Analysis
- Materiovigilance
