Clinical Affairs
We propose to our customers highly specific support for any medical device clinical investigation.
Project Management
- Project preparation and management plan
- Definition of key parameters (milestones, resources, logistics, project tools)
- Budget planning, administration and monitoring
- Consulting and preparation for clinical trial insurances
Planning and Preparation of Clinical Studies
- Design of clinical studies
- Advice on all study relevant aspects as for example study type, design, population, endpoints (pre- and post-market)
- Coordination with notified bodies/ authorities
- Design and preparation of study relevant documents
Clinical Regulatory Affairs
- Submission of essential documents to ethics commissions and competent authorities
- Obtain regulatory approvals and ethical votes
- Reporting to and communication with ethics committees and competent authorities
Medical Device Vigilance
- Ensuring compliance
- AE / SAE monitoring, evaluation and reporting
Clinical Monitoring & Quality Assurance
- Pre-study & initiation visits
- Monitoring & close-out visits
Data management
- Database solutions for data collection
- Design, preparation and validation of electronic case report forms (eCRF)
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