Vedic Lifesciences Completes Dietary Supplement Studies under GCPs

Vedic Lifesciences announces successful completion of clinical studies on two dietary supplements conducted strictly in compliance with GCP. By doing so Vedic aims at credible data that is less questioned by the stringent regulatory authorities for marketing of food supplements. End Quote

(1888PressRelease) January 24, 2012 - Redwood Shores, CA - Vedic Lifesciences announced today the successful completion of double blind, placebo controlled multicentric clinical studies on two dietary supplements. The studies were conducted to substantiate claims for these products in several markets, including US. Study data will be used for regulatory and promotional purposes. The two products are for men's health and women's health respectively.

Though these human studies were on dietary supplements the project team at Vedic was keen on conducting the study strictly in compliance with Good Clinical Practices (GCP), to ensure data credibility. Clinical Trials conducted under a GCP environment stand a better chance of being accepted by European and other such stringent authorities for marketing approvals of food supplements or novel foods. Officials at Vedic claim that even reviewers for several high impact journals check for possible bias in trial design and conduct and appreciate if the study has been conducted and reported using Good Clinical Practices and Good Statistical Practices.

Another major concern for a clinical trial is speed of volunteer enrollment. Meeting study timelines becomes difficult if the enrollment rate is low. The project team at Vedic anticipated the same for these studies. To overcome this challenge the sites were strategically selected and rigorously followed up.

The site staff was continuously kept motivated resulting in enrolment much ahead of time and maximum subjects completing the study. The establishment of a good rapport with its competent investigators had a positive impact in reducing the study timelines and ensuring reduction in development costs without compromise on quality.

Nutraceutical clients across the globe can avail of Vedic's full service spectrum and rely on the rich experience in conducting GCP studies in dietary supplements in areas such as Joint health, metabolic functions (lipid, sugar metabolism), respiratory health, heart health, Dermatology, Sports Nutrition etc. The benefits offered are tailor made projects for stronger claims substantiation, credible and GCP compliant data, publications in peer reviewed journals, resulting in quicker market launch.
"Following GCPs for supplement studies is worth the investment if any. Providing our client with credible data and protecting rights and safety of study volunteers is essential even if it is a study on a dietary supplement or an herbal product" commented, Jayesh Chaudhary, Chief Executive Officer, Vedic Lifesciences.

"We do not look at our client as mere lucrative accounts. We consider them as strategic partners. They can be sure to always find us by their side to help them deliver on their promise of enabling people to live healthier lives", added Dr. Navneet Sonawane, Manager - Clinical Operations.

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