CLINICAL TRIALS PROGRAM
Why Are Clinical Trials Needed?
In order to market a medical device intended for human therapeutic use, a regulatory body requires evidence that it is both safe and effective. Clinical information is necessary to demonstrate the benefit of using a device against the risks associated with its use. A manufacturer might demonstrate a device’s safety by conducting a clinical literature review for similar products but if clinical data are limited, a manufacturer must generate clinical information by conducting trials.
Clinical Trials Program
Quality First International’s Clinical Trials Program is designed to fulfill all your medical device clinical investigation requirements. Depending on your clinical needs, QFI will conduct an extensive literature review to identify relevant clinical data or carry out an entirely new clinical trial to verify the performance and safety of a device on your behalf.
Project Management
As a Clinical Research Organisation, Quality First International can manage every aspect of your clinical requirements. Working to international standards and regulations, QFI can plan, design and implement your clinical investigations. QFI has extensive experience in the following services:
- 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.
Regulatory Assurance
Quality First International can ensure that your medical device gains worldwide regulatory acceptance, irrespective of where it is to be marketed. QFI is experienced in preparing clinical trial applications 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 Assurance
Quality First International can provide you with quality assurance at any stage of the clinical trials process. QFI provides independent audits of the clinical trial including:
- investigator site audits
- trial master file audits
- database audits.
Good Clinical Practice Chart
The following chart highlights the primary steps involved in obtaining clinical information:
