Clinical Trials

Clinical trials are now an essential component for foods and food constituents in order to increase support for health claims. In most jurisdictions, animal and in vitro studies, on their own, are insufficient for the scientific substantiation of health claims. Instead, there is a requirement for data from well-controlled human intervention studies.

Many factors must be considered in the design of a clinical study to ensure that the objectives of the study will be met and to ensure that the results collected will be relevant to the proposed health claim. Also, Good Clinical Practice (GCP) guidelines, which are an international ethical and scientific quality standard for designing, conducting, recording, and reporting studies that involve human subjects, should be followed to ensure the credibility of clinical study data and the protection of study subjects.

Intertek Cantox, can provide support for your clinical trials from start to finish, including study design, placement, management, and manuscript writing.

Our services include:

• Preparation or review of clinical trial protocols to ensure compliance with GCP guidelines and that due consideration has been given to key factors that could affect the outcome of the study;
• Ensuring that the study outcomes meet the regulatory requirements for health claim substantiation;
• Preparation of other essential documents, including Investigator’s Brochures, Informed Consent Forms, and Case Report Forms;
• Assistance with clinical study placement;
• Monitoring of clinical studies, either according to Intertek Cantox standard operating procedures (SOP) or to the Sponsor’s SOP; and 
• Manuscript preparation and publication.