Vedic Extends its Nutritional Research Assistance Programme

Contract research organization (CRO), Vedic Lifesciences, has extended its Nutritional Research Assistance Programme. Numerous dietary supplement and natural health product companies from North America have taken advantage of the programme, but European interest has so far been limited.

Nutraceutical companies are often unsure about the type of clinical research that needs to be done to substantiate label claims. Vedic’s Assistance Program involves a limited time offer for a free clinical trial design and feasibility study for any two supplement/functional food products. Given a claim statement, Vedic Lifesciences’ Clinical Operations, Medical Writing and Regulatory teams will design a small exploratory human study and assess the feasibility of doing such a study in North America, Eastern Europe or Asia.

The trial can be used for publications or submissions to the regulatory authorities. The human data would be GCP-compliant and meet all international standards. The trial design and feasibility study typically involves a 50–100 h commitment, depending on trial complexity, and includes medical and regulatory expertise from several sites/offices.

Jayesh Chaudhary, CEO, revealed: “Existing clients from the US and Canada are very pleased with this service and how it supports their products’ marketing claims.” Following the free consultation, any further decision to conduct the study with Vedic Lifesciences or any other CRO is entirely optional. The clinical trial design and feasibility become the property of the food supplement company.

More information
www.vediclifesciences.com

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