Intertek provides scientific and regulatory support for food and supplement clinical trials.
Clinical trials can be an essential component for substantiating health claims for foods and food constituents and supplements. When properly conducted, they provide the highest level of scientific evidence into a cause-and-effect relationship.
Many critical 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 should be followed to ensure the credibility of clinical study data and the protection of study subjects. Intertek’s experts combine their understanding of the regulatory requirements for conducting safe and ethical clinical trials with the expertise in substantiating health claims to provide effective food clinical trial support for your needs.
Intertek can provide support for your food or supplement clinical trials from start to finish, including study design, placement, management, monitoring, and manuscript writing. Intertek has the expertise and global resources to successfully support its clients.
Intertek's Food Clinical Trials 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 study outcomes
- Assessment of study design and study outcomes to verify they meet the regulatory requirements for health claim substantiation
- Preparation of additional essential documents, including Investigator’s Brochures, Informed Consent Forms, and Case Report Forms
- Assistance with clinical study placement
- Monitoring of clinical studies
- Statistical planning and analyses
- Manuscript preparation and publication