Medicus Research Uses Virtual CRO Trial Method

LOS ANGELESMedicus Research's newest study, "High Potency Fish Oil Supplement Improves Omega-3 Fatty Acid Status in Healthy Adults: An Open Label Study Using a Web-Based, Virtual Platform" was published in the Nutrition Journal, using a virtual CRO method.

The study was authored by Dr. Jay Udani, CEO of Medicus Research and Dr. Barry Ritz, vice president of Scientific and Regulatory Affairs at Atrium Innovations Inc.

The study demonstrated the viability of a "virtual" clinical research organization (CRO) to substantiate claims that the consumption of a high potency fish oil supplement can improve blood levels of DHA and EPA and positively affect the quality of life in mental and physical health scores for healthy adults.

Garden of Life acted as the study sponsor and provided its Minami Nutrition® MorEPA® Platinum to  test how the increase in the subjects' blood levels of DHA and EPA positively impacted their overall general and cognitive health. The 120-day study included five virtual CRO visits and 157 subjects.

Medicus Research created a virtual clinical CRO system that can evaluate both patient reported outcomes (PROs) and certain biomarkers in remote subjects under the leadership of Dr. Udani. The company's proprietary CRO program was developed by Systemedicus, an affiliate of Medicus Research.

The virtual CRO was possible through a secure website where the subjects completed online informed consent and qualifying questionnaires that included medical history and quality of life health survey. The answers to qualifying questionnaires were validated by a phone call from the clinical staff. Subjects received an at-home finger-stick blood test to measure the amount of EPA and DHA in their blood at the beginning and end of the study, and completed the quality of life health survey.

The published manuscript states that the study is the first to report a significant increase in blood EPA and DHA levels, as omega-3 Index, in a group of healthy individuals who were regular consumers of fish oil supplements.

The study positively concluded that substantial improvements in blood EPA and DHA in the blood caused a significant increase in the subject's quality of life mental health scores when they took the investigational product.

In a statement, Medicus Research said it believes the virtual CRO model is important for the natural health products industry. The virtual CRO model establishes a method to obtain high quality clinical trial data or certain endpoints on larger populations, in timelines, and budgets which are faster and less expensive than traditional in-clinic studies.

Dr. Udani has won multiple awards for his research including first and second place at the 2013 Scripps Natural Supplement Conference, and was recognized on the PharmaVOICE 100an annual list of top life-science professionals.