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.
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.
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?"
Tags: Clinical Trials
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.
Tags: Clinical Trials
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.
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.
Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.
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:
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.
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.