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CRO partnerships: how clinical trials communicate health credentials and take products to market

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Clinical trials represent an opportunity for nutraceutical companies that want to prove their health benefits in the US market. Find out how partnering with a CRO can help your company benefit from this opportunity.

In 2021 the global functional packaged food market was worth $177.4 billion USD.1​ Therefore the need for scientific research is becoming even more relevant as the modern consumer demands food products that meet their health and nutritional needs. Contract Research Organizations (CROs) meet market needs by helping food and nutraceutical companies prove their innovations and by scientifically backing products being brought to market.

Clinical trial multicenter capabilities

Atlantia was formed 10 years ago under the core value of innovation and learning by driving clinical research forward, having spun out of the world-renowned microbiome institute, APC Microbiome Ireland. Atlantia Clinical Trials combines strong ties with the academic community while operating as a CRO where the Intellectual Property (IP) belongs to the sponsor. 

Having both the science team and the recruitment site under one company is not a typical model for a CRO. Andrea Doolan, Atlantia’s CEO, reinforces how this guarantees consistency and continuity in how clinical data is collected and processed. Atlantia owns and operates their clinics offering their clients multicentre and multinational trials on both sides of the Atlantic in their bases in Cork, Ireland and Chicago, USA. This is an advantage that sets them apart as all aspects of a trial are conducted by a single research partner in a highly GCP-compliant (Good Clinical Practice) setting. Multicentre research has the advantage of offering a larger sample size, reaching a more diverse population base.

Clinical research expertise

Companies with food components and/or naturally occurring products have partnered with Atlantia to conduct high-quality research allowing them to make claims based on solid scientific evidence. Onthatile Serehete, Atlantia’s Medical Study Manager, says: “This is a much-neglected area in the scientific community to research natural products and their impact on clinical health outcomes​. Too many supplements are marketed without appropriate evidence."

By investigating and scientifically researching how different ingredients are contributing to human health Atlantia offers an end-to-end service, from protocol development, ethics submission and data management to recruitment, study conduct, monitoring, statistical analysis and final report writing.

From the outset, Atlantia gains insight into the specific market objectives of the trial sponsors while the CRO designs and conduct studies based on the company’s requirements. This is a unique opportunity for start-up companies to have scientific advice from global leaders in their field of research. Fully aware that many companies have limited resources, they achieve goals in a cost-effective manner. “Conducting a study based on unlimited resources is easy, but we pride ourselves on achieving objectives within limited budgets and within predefined timeframes,” ​explains Ted Dinan, Atlantia’s Medical Director.

Markers of success across clinical trials

Over the last 10 years Atlantia has been involved in over 550 projects with more than 300 sponsors across multiple health areas. The products studied vary from small molecules to probiotic bacteria. Many of the early studies focused on probiotics, gut health and elements of metabolic syndrome and since diverged into areas such as sports nutrition, brain health, women’s health and skin products. Atlantia has worked with many novel food formulations from fermented coconut milk with beneficial GI applications to natural alternatives to dietary sugars.

Over the years, Atlantia has performed many different types of trials including bioavailability, observational and interventional studies that are acute or longer term, as well as challenge models. Trials have ranged from open-label safety and tolerability trials to randomised, controlled efficacy trials to questionnaire-based and collecting biological samples such as blood, fecal or skin, for specific biomarkers, and even using specialised technologies such as Video camera endoscopy, cognitive test batteries or Antera 3D for beauty and cosmetic studies. Studies start from 20 participants up to 600, ranging in age from three months to 90 years old.

Clinical Team growth  

One significant marker of the company’s growth has been the expansion of a multidisciplinary team which today consists of over 85 employees across many different departments with operations staff including Clinical Research Associates and Coordinators while the Science team is made up of Biostatistics, Medical Doctors and Nurses, among others.

Breaking into new therapeutic areas and populations 

In 2019, a new clinic site along the Magnificent Mile in Chicago opened,  allowing the company to expand its offering to multicenter trial capabilities. An ​opportunity arose when some of Atlantia’s clients requested in-market trials to be done in the US and therefore it was a natural next step in the company’s progression and expansion into new markets. The facility comprises an impressive 7,500 square feet of clinic space for labs, phlebotomy, offices and waiting rooms and a fully operational clinic.

In 2021 the team expanded its capabilities to cater for Skin & Cosmetic clinical trials. The research team has acquired various new technological devices to facilitate conducting these new types of trials.

Technological advancements

Throughout the years Atlantia has created a robust clinical trials process through the use of technology, driven both internally with the science department and externally with its clients. Due to the nature of the company, validated medical devices have been particularly relevant. For example, in some gastrointestinal studies, the company worked with video camera endoscopy technology. This device takes internal high-definition images of the gastrointestinal tract. Other devices the company has worked with over the years are Continuous Glucose Monitoring (CGM), or sleep trackers, such as Actigraph. Wearable sensors have also driven the shift of trials from clinic to the home, as clinical data can be collected at the subject’s home on a continuous basis. 

As the company has ventured into the dermatology and cosmetic research space, they have incorporated new equipment into their facilities such as the Cornometer, Cutometer and Antera 3D. Recently, the company has acquired a DEXA scan which has enabled it to expand its offering and provide vital assessments by measuring visceral fat, adipose tissue, bone density and water in the body for various studies. This has changed the course of some trials in the areas of weight management. The incorporation of newly validated technologies and methods is of upmost importance. Equipment devices and methods are becoming more robust gathering results and help Atlantia in designing interventions that are less invasive for participants and reflect in a higher degree real-world settings. This increases the compliance of participants but also assists in getting quicker ethical approval by the respective bodies. 

Another method of streamlining the processes has been thanks to the incorporation of digital apps in clinical trials. The study apps enable the capture of participant data remotely at the point of care on a daily basis. This method has been shown to increase study adherence and compliance. Information such as how participants are consuming the product, the frequency of consumption and if they are experiencing any adverse effects can be collected.

Technology has been shown to optimise clinical trials. As noted, some of these technologies increase the quality of data collected and provide real-time analysis of how a product behaves in the real world, allowing for higher quality research which enables companies to deliver better, more customised products to the market.

Overall it is evident that CROs are needed to fill the gap to help for nutraceutical and functional food companies back their innovations with scientific research. Substantiating a product by way of clinical studies will not only help bring it to market, it will also provide added value to the final marketed product. The clinical trial landscape has advanced extensively in the last 10 years and this can be seen through Atlantia’s technological endeavours.

References

1.​ Health and Wellness: Euromonitor from trade sources/national statistics.

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