CRO launches certification to vet quality of claims validation

15-Jun-2018 - Last updated on 15-Jun-2018 at 16:05 GMT

The Strongscience certification can help consumers differentiate validated claims from those that are not well supported, the developer says. Photo: Strongscience

Related tags clinical research CRO Certification

Global Clinicals, a contract research organization (CRO) based in Los Angeles, has launched a certification the founder says will help companies differentiate themselves based on the quality of the research that backs the claims they make on their products.

The new certification, called Strongscience, was launched at the recent International Society of Sports Nutrition annual conference held last week in Clearwater Beach, FL.

Clinical trials as a business function

Chris Baker, CEO of Global Clinicals, said he saw the need for the service based on his experience of running his own CRO.

For the past 18 years Global Clinicals has organized a number of clinical trials for companies in the dietary supplement industry, especially those in the sports nutrition sphere. Baker, who is not a researcher himself, said he got his start in running a CRO by organizing a trial for one of the first big OTC cold remedies called Zicam.

“I knew the guy who invented it,” Baker said. “Zicam is one of the leaders in the market as a kind of homeopathic cold remedy.

“My background is more in business management and operations, but he asked me if I could help in organizing the clinical trials on the product,” Baker told NutraIngredients-USA.

Baker was also at one time the owner of a gym, which is where the sports nutrition angle came in.

“I also started to run clinical trials for a sports brand which at that time was known as Muscle Tech,” he said.

Wide range of quality in claims substantiation

Baker said his almost two decades of involvement with clinical trials has given him insight into the dos and don’ts of how this information is used in the marketplace. There is a core of top-shelf ingredients with good science behind them. There are reputable finished brands that use these ingredients in the recommended dosages and so have solid underpinning for claims.

Then there is a penumbra of ingredients and finished products that don’t clear that bar. They might have science-backed, branded ingredients in the product, but don’t use the studied dosages. (Many branded ingredient suppliers claim they support only the use of clinically relevant dosages, but most seem to find ways to ‘work with’ clients who choose to use lesser amounts.)

Or there are manufacturers who are outright pixie dusting with those same ingredients. And then there is the broad periphery of products that rely on completely commoditized ingredients. It might say ‘turmeric’ on the label, but is that what’s in the bottle? And how does the science done on a standardized extract relate to a generic root powder?

As complicated as some of these issues can be for experienced professionals to sort through, they are well beyond the ken of all but the most in-the-know consumers. With so few ways for consumers to tell the wheat from the chaff, Baker said he saw a business opportunity.

“The main purpose for doing a human clinical trial would be as a health claim validation. They are pretty expensive to do so it takes companies a while to see how they are going to approach that in their budget. Strongscience came out of the fact that a lot of companies weren’t going ahead with these full clinical trials, but there were still a lot of health claims in the market,” Baker said.

Certification process builds up dossier for product

Baker said the service includes a literature review of all relevant research to back a claim.

Global Clinicals will then write up a complete review of the product that could be used in proving claims validation when communicating with potential retailers such as Costco, he said. Baker said that if a product was found to need additional science backing, those studies would need to be done before the certification could be granted.

The certification logo also includes a QR code that goes on the label. Scanning it links consumers to the research that was reviewed in vetting the veracity of the claims made on the product.

“We take a look at the product as a whole and review all of the relevant research. We look to make sure there are efficacious dose ranges. We don’t certify for GMP, but to get our certification we would require that a manufacturer is GMP certified,” Baker said.

“This is a patented process I started working on about eight years ago. I think we are doing something that no one else has done. We are a third party that is putting all the research out there so that it is fully transparent,” he said.