Nutrasource Pharmaceutical and Nutraceutical Services Inc. has announced a rebrand of its clinical trial site in Southwestern Ontario, Canada.
 
The site, now rebranded as Apex Trials, specializes in phase I, pharmacokinetic, and phase IV studies for both pharmaceutical and nutraceutical products. The site will focus on studies for both product types related to cardiovascular disease, dyslipidemia, irritable bowel syndrome (IBS), hypertension, diabetes, and weight management.
 
“We are excited to launch our clinical trial site under the brand of Apex Trials,” said Joshua Baisley, SVP Clinical Operations. “We deliberately separated the operations of our site from our CRO activities many years ago to differentiate ourselves from our competitors and demonstrate our commitment to compliance thereby protecting our Sponsor’s investment. With a team of over 20 staff, 20 years of clinical trial experience, and a client-centric approach.”
 
Nutrasource will continue to offer clinical trial services through its own contract research organization and clinical trial site divisions, and operates the units separately to ensure compliance with regulations, said Baisley.
 
“We rebranded our site as Apex Trials to further define this separation of activities but also to facilitate the site to operate more independently whereby the site can with sponsors and other CROs directly, independent of our CRO service offerings.”
 
Apex Trials’ 17,000 square foot clinical trial suite operates under principal investigator Dr. Anthony Bier, along with medical and scientific personnel including: emergency medicine specialist; nurse practitioners; clinical research coordinators; MLPAO/CSMLS certified medical laboratory professionals; pharmacy staff; quality assurance and quality control personnel; and a dedicated participant recruitment team. Associations represented across the team include SOCRA, SCRS, SQA, N2 Network of Networks, and CITI Program.
 
“Over the past decade, I have been able to witness and appreciate the evolution of our clinical trials unit,” said Katie Keene, clinic supervisor. “I am very proud of the team for accepting and embracing all the physical and procedural changes we have implemented over the years benefiting both our clients and our participants. This latest change is our biggest and best yet as it will allow us to expand our focus beyond food and natural health product trials to include pharmaceutical trials, further growing our site’s portfolio of offerings.”
 
Expanded Capabilities
 
Apex Trials site has expanded its size, the capabilities of what kind of trials it can run, other licensing, and staffing.
 
“Over the past few years we have gone through several expansions of the space to facilitate our clients requirements and increased security measures to obtain both our institution wide cannabis license and our controlled substances license to facilitate research on any substances our clients may want,” said Baisley. “Beyond the physical changes there was not much more work that needed to be done as we have always abided by ICH guidelines and activities for pharmaceutical research and nutraceutical research at the site level are identical.”
 
Currently, depending on the projects’ specific requirements, population, participant numbers, and other factors, the site can run a limit of approximately three to six concurrent studies. Baisley said. He noted that having the capability for pharmaceutical studies will provide a “feedback loop” of benefits for studies on nutraceutical ingredients.
 
“The benefit to our nutraceutical studies is that pharmaceutical studies are more likely to receive regulatory inspections and client audits,” Baisley said. “This feedback loop is not only welcomed by our team but also provides us feedback outside of our own internal audit programs. We went through one such audit recently to join a site network and received positive feedback, no findings, and some observations to help us continually improve. Joining this network further helps our nutraceutical offering as it provides us access to a community of premier sites where we can share bets practices and work together to optimize processes and increase compliance.
 
“Another benefit is our continual focus on expanding capabilities. For example, in a recent expansion we renovated the space to allow us to conduct early phase studies with this requirement. This is often standard for pharmaceutical early phase studies and may be of interest too some nutraceutical clients but few sites in our industry have this capability.”
 
The Pharma Influence on Supplement Research
 
Nutrasource has taken a pharmaceutical approach to nutraceutical studies, Baisley said, however, there is always a risk-based approach. “At the site level, there is no difference as the documentation and processes are identical,” Baisley said. However, there is more flexibility on certain levels for nutraceuticals based on how much rigor is warranted by a risk assessment.
 
“Guidelines and regulations are focused on ethics, integrity, compliance, and quality,” Baisley said. “These should be standard expectations we place on ourselves in this industry given the nature of the work we are doing to bring safe products to the consumer backed by reliable science.
 
“Compliance with international guidelines and regulatory expectations should be the standard. However, many researchers and research groups do not do this as it takes and investment in both facilities and personnel. We focus on our staff’s continual education, training, qualifications, and separation of activities to ensure that tasks are executed only by qualified staff in compliance with local and federal laws. Compliance with good clinical practice and good documentation practice is crucial to conducting a robust clinical trial as well as ensuring our staff’s knowledge and skills are continually updated. We do this through internal training, internal mentorship programs, and external training which is a large investment in time and cost but has positive impact on both our staff and our clients.”