Need a clinical trial for a medical device in Europe?
Could your technology lead to an innovative medical application?
CERES can help you to access the European market!
A clinical trial is conducted to determine the safety and performance of a medical device according to Medical Device Regulation (MDR). In particular article 62 determines the requirements regarding clinical investigations conducted to demonstrate conformity of devices.
Our clinical trials enable you to:
- ■ explore device feasibility
- ■ investigate new technologies
- ■ gain first-in-human experience
- ■ support your application for CE approval
- ■ gain approval for additional intended uses of your device
To achieve CE approval for high-risk medical devices, such as long-term invasive applications or implants, clinical trials must be conducted unless the use of existing clinical data can be sufficiently justified. Depending on the goal of your study, various study designs could be useful, ranging from a single-center non-randomized trial to a multicenter, multinational, randomized, controlled trial.
CERES offers the full chain of services for device trials.
We can manage your trial, and help you with planning and design. For questions about eligibility and submission procedures, our regulatory affairs team can support you in finding answers. We can help you to select the best study sites, monitor your trial, collect and analyze your trial data, and write the reports for your trial. Thus, we can run your whole trial, or provide just the help you need to succeed.
CERES provides the following Services:
- Composition of study-hypotheses, aims and endpoints
- Evaluation of the adequate study-type with respect to
size of the population, test-significance and duration of observation
- Selection of population and planning of recruitment
- Specification of suitable statistical reporting and analyses
- Creation of the clinical investigation plan (CIP)
- Selection of study centers and clinical investigators
- Study preparation and justification
- Data management
- Communication with ethics committees and authorities
- Preparation and registration of documentation components and case report forms (CRF)
- Data capturing and administration
- Checking on plausibility, integrity and validity of data
- Independent monitoring
- Preparation of the data
- Description of the sample
- Tests on hypotheses and identification of parameters
- Descriptive and explorative data analysis
- Interpretation of the results
- Evaluation with regard to performance and effectiveness
- Monitoring reports
- Interim reports
- Final reports
At CERES, outsourcing your clinical trial offers a lot of benefits:
- modular, and transparent cost structure
- efficient introduction of your products to the market
- early return on your financial investment
- flexible use of our resources according to your requirements
- additional expertise at the interface between user and manufacturer
While CERES does not do U.S. FDA submissions, data collected by CERES may be used to support your FDA submission. To do this, your plan for eventual FDA submission must be included in your clinical trial design, because trial design to achieve data for CE approval differs from trial design for U.S. FDA approval. Thus, before finalizing the design of your clinical trial with us, we should discuss your device distribution goals, so that your study design will best meet your future needs. Certainly, we can run a clinical trial for you that will provide data acceptable for both CE and FDA approval.