Nutrasource Blog

How to Form a CRO Partnership That Delivers Results

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Mon, Oct 15, 2018

The term "partnership" has become a trendy word in the contract research organization (CRO) world. While it's meant to describe a close collaborative relationship between CRO and client, too many organizations claim to be partners when in reality they are only research sites or project-based consultants.

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Tags: Clinical Trials, Concept to Claim, Regulatory

Reverse-Engineering Your Regulatory Strategy for More Efficient Product Development

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Thu, Jul 12, 2018

Regulatory strategy is the backbone of successful product development. Brands that lack a clear regulatory plan at the beginning of the process can face longer times to market and potentially higher costs associated with re-work or failure.

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Tags: Clinical Trials, Regulatory, Dietary Supplements/Natural Health Products

What to Expect When Conducting Dietary Supplement Clinical Trials

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Tue, Mar 20, 2018

One of the most common questions we hear from clients early in the product lifecycle is: "How do I let my customers know our product is safe, and that it works?"

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Tags: Clinical Trials

Planning for Risk Mitigation Is Key to a Successful Clinical Research Strategy

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Fri, May 05, 2017

Investing in clinical research is necessary to establish a product’s safety and efficacy. Whether this is your first clinical study on your product or you’ve conducted a number of clinical trials to substantiate claims for your dietary supplement, begin with the understanding that there are risks of all shapes and sizes involved and that the project manager’s first order of business is to eliminate or mitigate as many as possible.

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Tags: Clinical Trials

Managing Risk in Probiotic Stability

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Tue, Apr 11, 2017

A comprehensive clinical testing program is essential to the success of virtually all health products. Writing in the International Probiotics Association blog, Josh Baisley, associate director of clinical trials for Nutrasource, notes that ensuring the stability of a probiotic for the duration of clinical studies is a vital aspect of analyzing the outcome. 

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Tags: Probiotics, Clinical Trials

Demystifying Clinical Study Designs for Probiotics

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Wed, Oct 12, 2016

As the probiotic segment continues to trend upward, more companies are investing in well-designed clinical trials to support efficacy.

One area that has presented substantial learning opportunities, and has helped shape the future of probiotic clinical trials, is the study of antibiotic associated diarrhea (AAD) and probiotic intake.

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Tags: Clinical Trials, Probiotics, Dietary Supplements/Natural Health Products

What to Look for in a Dietary Supplement CRO

Posted by Nutrasource on Wed, Aug 31, 2016

Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.

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Tags: Clinical Trials, Regulatory, Dietary Supplements/Natural Health Products

5 Essential Tips for Substantiating Dietary Supplement Claims

Posted by Jennifer Andrews, M.Sc. on Mon, Jun 13, 2016

Product claims are a key component of dietary supplement positioning and marketing. Companies use claims to showcase their product's health effects, nutritional benefits or performance to reinforce brand values and help boost sales.

Substantiating product claims is an important aspect of any product launch or
repositioning strategy. Not having the right type or level of data required to support a
claim can put a brand at risk for regulatory consequences, negative publicity and,
ultimately, a loss of market share and competitive advantage.

Below are five essential tips and best practices from our Dietary Supplement Claims Substantiation E-Book which you can use to develop an effective claims strategy for your dietary supplement:

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Tags: Product Marketing, Clinical Trials, Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

Taking an Integrated Clinical and Regulatory Approach for the Prebiotic/Probiotic Market

Posted by Jennifer Andrews, M.Sc. on Wed, Jan 27, 2016

Prebiotics and probiotics aren't going anywhere.  In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics. Here we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.

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Tags: Clinical Trials, Pharmaceuticals, Regulatory, Dietary Supplements/Natural Health Products, Foods & Beverages

Understanding the Differences Between Phase I, II, III, and IV Clinical Trials

Posted by Josh Baisley, B.Sc., Director of Clinical Trials - Domestic on Thu, Dec 03, 2015

Study designs need to support the final claims including marketing claims.  Risk management is a key aspect of formulating a robust clinical development program and may include proof of concept studies such as dose ranging or multiple dose studies and pilot studies, prior to engaging in pivotal clinical studies to determine evidence of effect and variability around changes resulting from supplementation with the investigational product.

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Tags: Clinical Trials, Dietary Supplements/Natural Health Products