Pioneer in clinical device trials
Clinius is a Finnish pioneer in clinical device trials, experience starting from late 80's with hospital co-operation in medical device testing. With this background we provide clinical development services from the planning of end-to-end trials and testing programmes to the planning, approval and implementation of individual trials and tasks. We also provide clinical trial management software (eCRF) as a service to ease the management and monitoring of clinical device trials. We execute clinical trials in compliance with the Declaration of Helsinki by the World Medical Association and the ISO 14155 standard. The results from clinical trials and tests can be utilised in:
- Attestation of conformity of products (CE-marking)
- Optimisation of product specifications
- Further product development
- Marketing
Our service offering
- Management of clinical information
- Clinical evaluation
- Clinical device trials Case Elekta
- Clinical trial management software (eCRF) as a service
- Scientific literature review
- User-centric device testing
- Verification and validation testing
- Specialist resources for planning, execution, evaluation and review
- Post-market surveillanc
