Randomized Double-Blind Placebo-Controlled Clinical Study

• Pilot
• Short Intervention Time: Up to 3 Months
• Medium/Long Intervention Time: 6-12 Months

These studies are the gold standard of clinical trials for foods, supplements, and homeopathics. We work with you to design and conduct a trial best suited to your product or ingredient. We design your trial to ensure that not only the right outcomes are being examined, but that the entire package efficiently aligns with regulatory and marketing approvals. There is no better approach to protecting a brand with the most robust Claim Substantiation on file from your very own clinical trial.

Product Feedback (Homeopathics, Cosmetics, Dietary Supplements, and Foods & Beverages)

• Intervention: 1 month to 3 months

These types of studies are designed for well articulated consumer feedback as well as product effectiveness. Multiple demographics can be assessed simultaneously or in a sequential strategic approach. Study examples include testing if a cosmetic reduces the appearance of lines and wrinkles, if a supplement flavor taste good as well as how consumers feel about a using or consuming a given product. These studies are also key in the effort of refining ones marketing/branding and with Claims Development in support of building a robust substantiation dossier.

Pharmacokinetic/Absorption Study
(Cross-over)

Want to know if your product absorbs effectively? Need to benchmark against other products in the marketplace? Pharmacokinetic studies are performed to understand the absorption, distribution, metabolism, and excretion of a substance in the body. But they can also be used to understand new technologies, absorption enhancers or if combining ingredients changes their bioavailability. Comparison Studies also take into account the performance relevant to other claims in the marketplace.

Human Safety Study
(Homeopathics, GRASN, and NDIN)

Human safety is the keystone concern by the Food and Drug Administration for ingredients that are deemed Generally Recognized as Safe (GRAS) intended for use in traditional foods and beverages or that are qualified as New Dietary Ingredients (NDI’s) for use in dietary supplements with the US market. Human safety is also paramount for Homeopathic ingredients and finished products in accordance with recent final guidance. Now you can support your existing historical use and animal data with a trial in humans specific to your ingredients and dose that alleviates regulatory challenge.

Post Market Marketing FeedBack
(Homeopathics and Dietary Supplements)

• Intervention: Up to 3 months

Often companies with aggressive Go-to-Market strategies or with Brands that happen to have gone viral, do not have the added benefit from early market research or any structured means of critically evaluating consumer feedback beyond social media sites and testimonials. These studies provide a careful critique and assessment with statistical inputs as to how a product is first defined post launch and captures essential consumer micro-evolution data.

Cosmetic Study

• Intervention: 1 Month
• Safety and allergen evaluations
• Performance & Claim Support
• Comparative Studies

Safety, beautification, performance, and product comparator studies in the Cosmetic industry are key to brand differentiation and long-term success. Studies are designed to meet the current regulatory requirements based on the application types and to align with intended positioning of the product.

Kitting and Clinical Trial Materials

Design of the kits or Clinical Trial Materials (CTM’s) is key to any human study or trial being executed properly. Protocols to control for material receipts and disposition, coordination with co-man’s or co-packers, storage control and monitors are part of the solutions offered, but we can also provide the management of study or trial materials to Sponsors to meet specific needs or situations as a standalone service to other Clinical Service Providers or Brand Owners performing their own studies.