Clinical Approval - CRO
Preclinical and clinical evaluations
We ensure the relevant qualification and competence to perform the clinical evaluation for you:
- Analysis of the degree of innovation and relevant clinical risks of your products.
- Feasibility studies prior to product development
- Identification and evaluation of equivalence products – also for 510(k) procedures at the FDA
- Preparation of a clinical evaluation plan and a strategy for market approval
- Execution of the clinical evaluation according to MEDDEV 2.7/1 Revision 4 including preparation of the clinical evaluation report (CER)
- Scientific literature search for the planned clinical application (indication/prevalence/state of the art in therapy and diagnosis)
- Scientific literature search on equivalence products
- Assessment of relevance (PICO) and methodological quality of the identified clinical data
- Inclusion and evaluation of post-market surveillance data
- Sound advice on the decision on the need for a clinical trial
- Analysis of data and assessment of compliance with essential requirements (safety, performance, benefit/risk, side effects)
Clinical tests/studies
Our experienced CRO consultants organize for you and support by:
- Formulating the objectives and hypotheses of a clinical trial/study according to EN ISO 14155
- Conducting various types of studies (PMCF, IIT, pivotal studies, reimbursement studies, etc.)
- Preparation of the necessary technical (minimum) documentation
- Determination of test location and interfaces
- Drafting of contracts and organization of insurance contracts
- Obtaining the initial approval for the clinical trial
- Project management of the clinical trial including budget management
- Continuous monitoring as well as support and coordination of interfaces
- Ensuring trial documentation, data management and data protection
- Monitoring compliance with regulatory requirements
- Evaluation of data from clinical trials according to statistical, biometric and other aspects
- Preparation or review of the study report
- Medical writing including relevant data, regulatory requirements and current formats
Post Market Surveillance (PMS), Vigilance, Post Market Clinical follow-up (PMCF)
We provide evidence of the safety and benefits of your medical device by:
- Conducting annual market surveillance with schedule monitoring.
- Analyzing the clinical evaluation, the risk management files and the usability
- Engineering files for timeliness
- Collecting, evaluating and reporting incidents
- Preparation of “Field Safety Notice (FSN)”, “Field Safety Corrective Action (FSCA)” plan (Article 89 MDR).
- Post-market surveillance report in accordance with Article 85 MDR.
- Preparation and maintenance of the report on safety (“PSUR”) Article 86 MDR.
- Scientific literature search as a continuation of the clinical evaluation regarding new evidence from the literature and regarding safety and benefits for the product being evaluated
- Research on current guidelines from professional societies and information from authorities
- Analysis of incidents reported to the manufacturer regarding the product as well as comparative products according to MEDDEV 2.12-1
- Market surveillance research via international databases
- Risk assessment with regard to reported incidents
- Support for the decision on the necessity of post-market clinical follow-up studies