
CLINICAL TRIALS PROGRAM
Quality First International’s Clinical Trials Program is designed to fulfil the US Food and Drug Administration, UK, European, Australian, Japanese and Canadian medical device clinical investigation requirements plus recomendations and guidelines such as ICH. Depending on our clients’ clinical needs, QFI can conduct an extensive literature review to identify relevant clinical data or manage an entirely new clinical investigation to verify the performance and safety of a specific medical device. As a Clinical Research Organisation, Quality First International manages, plans, designs and implements every aspect of the clinical trials process on behalf of our clients, working to international standards and regulations. QFI aims to ensure that our clients’ medical devices gain global regulatory acceptance and to provide quality assurance at any stage of the clinical trials process. QFI is experienced in preparing clinical trial applications for example, for:
- The US Food and Drug Administration
- Europe’s directives including the Medical Devices Directive
- The Japanese Ministry of Health and Welfare
- The Canadian Medical Devices Conformity Assessment System
Quality First International has extensive experience in the following:
- Submitting applications to the appropriate body
- Performing feasibility studies
- Designing clinical trial protocols
- Preparing Case Report Forms
- Investigator and site selection
- Coordinating clinical trials
- Analysing clinical data
- Outlining key results in a technical summary
- Preparing Interim and Clinical Investigation Summary reports
- Preparing final reports
- Conducting post-market studies