NutraCast: Compliance amid a pandemic with CRO NutraSource

By Danielle Masterson contact

- Last updated on GMT

NutraCast: Compliance amid a pandemic with CRO NutraSource

Related tags: compliance, Amazon, CRO, COVID, nutracast

Nutrasource, a Canada-based contract research organization, quickly adapted to the pandemic by implementing regulations and best practices to continue running human trials. The company’s president and CEO, Will Rowe, and Josh Baisley, VP of clinical design & delivery, joined the NutraCast to detail what goes on behind the scenes of a global CRO in the time of Covid.

“When COVID came about we actually saw signals from Asia in particular, from our Asian clientele as early as late January 2020, that this wasn't some necessarily regional thing. It was likely going to go global and have massive ramifications for society,” ​said Rowe. “Fortunately we are positioned with roughly a third of our staff already working remotely. So the adjustments for them were not as significant as they are or were for other members. The other key thing is because we are in the research field, we were deemed an essential business. So our clinical studies that were underway could continue. One of the other things we were heavily involved with was regulators, who were already warming up to decentralized studies or remote study some people like to call them and in that respect, we'd already peacefully done and delivered a couple of these prior to COVID even being the thing.”

Baisley explained that his team began prioritizing projects early on to address risks and nuances with the pandemic, including supply chain concerns, crossing the border with supplies and the changing regulations. 

“I started to look at all the regulatory agencies around the globe. It started with the UK releasing some guidance on March 12th followed by the FDA on the 16th, 2020 and then it continued throughout different government agencies and those organizations across the world to regulatory agencies. They continue to put out updates and different organizations were giving out different tidbits of information. So you could really start to see where things were heading and get ahead of some major changes that needed to occur,”​ explained Baisley. 

Following Amazon’s new set of compliance requirements, Nutrasource and Alkemist Labs teamed up to assist brands with meeting these requirements to maintain listing status. 

Nutrasource helps supplement companies with claims substantiation, technical label review and testing specifications and Alkemist provides developed and validated methods along with corresponding lots, specific test results, and certificates of analysis.

To learn more about what NutraSource is doing to help brands with Amazon compliance and in other areas, listen to the NutraCast.

You can also subscribe wherever you get your podcasts, including iTunes​, Spotify ​, Stitcher​ and Google Podcasts​. 

NutraCast is a podcast that focuses on insights from inside the nutrition industry. It is a production by NutraIngredients-USA. Music by Kevin Macleod.

 

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