This is a CRN Associate Member Spotlight. Learn more: www.nsf.org
A well-designed clinical study strengthens consumer trust and brand credibility in a competitive market. Dietary supplement companies face increasing scrutiny on product claims, requiring well-structured clinical trials to support efficacy and safety. Supplement trials require different considerations than pharmaceutical studies, with unique requirements for study design, population selection, and endpoints to ensure the results are both scientifically valid and commercially relevant.
Amarex Clinical Research, an NSF Company, is a global contract research organization (CRO) that specializes in guiding supplement brands through the clinical trial landscape, helping them design studies, meet regulatory expectations, and generate credible scientific data.
Amarex helps companies navigate:
- Study design considerations – Sample size, choosing the appropriate endpoints, right methodology, whether randomized, placebo-controlled, or other format, to generate meaningful data.
- Regulatory alignment – Ensuring study outcomes align with FDA and FTC expectations for claims substantiation.
- Customized trial strategies – Tailoring research approaches based on product type, such as botanicals, probiotics, and other innovative functional ingredients.
- Conducting systematic reviews and meta-analysis
- Appropriate data capture and randomization systems to conduct clinical trials tailored for dietary supplements
- Data analysis and preparation of publication, including peer reviews to ensure high quality and reliable findings
Clinical research is just one piece of the compliance puzzle. Dietary supplement brands must navigate regulatory submissions, quality management, and global compliance requirements. Amarex and NSF regulatory experts help supplement manufacturers understand:
- When a clinical trial is needed vs. when alternative substantiation may suffice
- How to prepare for FDA inspections or regulatory inquiries
- Strategies for maintaining compliance
For companies exploring ingredient innovation or bioavailability studies, Amarex partners with NSF’s bioanalytical research services offer advanced testing capabilities, with technologies particularly relevant for:
- Assessing nutrient absorption in functional ingredient formulations
- Heavy metal testing to meet stringent safety regulations
- Developing and validating new testing methods for complex dietary matrices
By combining scientific expertise with regulatory insights, Amarex and NSF help supplement companies make informed, strategic decisions—whether they are conducting a full-scale clinical trial or refining their compliance approach.
Explore Amarex’s Amarex | Clinical Trials & Clinical Research Organization clinical development and regulatory services.
Want to learn more or have questions? Contact Anthony Riggio.