ACElerator: Client - CRO Model

                                                                                              

Conduct of clinical trials has always been a challenge for the Natural Product industry with regards to cost and data credibility.  As a result many companies prefer not to invest their resources in R&D activities at all. To tackle such issues and instill confidence in our clients, Vedic Lifesciences offers a unique Client – CRO model for all Claim Substantiation Human Studies – ACElerator.

Under ACElerator, we share the project responsibilities with you and train your in- house team in areas like site selections, monitoring, data management and data capture. We would support with clinical study documentation, statistical analysis and report writing. With your trained team we will generate reliable human data for your products at a substantially reduced cost. This data can be presented or published in a high impact factor, peer reviewed journal. An additional benefit of this program is the creation of in-house research capabilities in your companies for future clinical trials.

Nutra/Dietary supplement/Traditional Medicine companies looking to increase their brand value or expanding their product line in new geographies without significant R&D investments can make optimum use of Vedic Lifesciences’ new ACElerator model.

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Industry News

The health care industry is a critical com­ponent of economies worldwide. As economic meltdown begins drug/supplement companies are trending towards shelving early-stage projects and working on late phase development. In a shaky economy, demand from clients is slack. As these companies move to rationalize their pipelines, CRO's are competing for fewer projects and RnD dollars while trying to achieve the same scale as in years past. A slump in early phase development is not bad news. Contract research organizations begin to engage in preferred partnership and strategic alliances to combat the Big R – ‘Recession’

Vedic Screen Sites in Malaysia for Future Studies

Nutraceutical companies no longer wish to restrict themselves to domestic markets. Multi-national clinical trials help such companies to test foreign markets as well as reduce R&D costs. To meet this objective Vedic Lifesciences has started expanding its operational reach to different parts of the globe, starting with South East Asia. Identifying potential sites for future studies in Malaysia has commenced. Talks have been initiated with General/Family Physicians, Endocrinologists, Cardiologists, Orthopedics, Urologists, etc. across various hospitals in Malaysia. These sites have a huge patient database as well as good experience in the conduct of clinical studies which would help western companies enter a lucrative USD 1.2 Billion Malaysian Nutraceutical market.

Market News

EFSA rejects Wheat Lipid-Dehydration Health Claim

The European Food Safety Authority (EFSA) has rejected a proprietary science-backed health claim that sought to link reduced skin dehydration with ‘Wheat Polar Lipid Extract.’

http://www.nutraingredients.com/Regulation/EFSA-rejects-wheat-lipid-dehydration-health-claim

Ongoing Clinical Trials at Vedic

Health Condition - DIABETES MELLITUS
Sponsor Location - GERMANY
Study - OPEN LABEL EXPLORATORY (PILOT) ADD-ON STUDY IN  NIDDM PATIENTS
Status - COMPLETED THE CLINICAL PHASE, DATA MANAGEMENT ONGOING. RECRUITING PATIENTS

Health Condition - CHRONIC RHINITIS
Sponsor Location - INDIA
Study - RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY IN PATIENTS WITH CHRONIC OR RECURRENT, NON-INFECTIVE NASAL CONGESTION WITH-OR-WITHOUT RHINORRHEA
Status - COMPLETED RECRUITMENT

Health Condition - GOUT
Sponsor Location - INDIA
Study - A RANDOMIZED DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE EFFICACY OF A HERBAL SUPPLEMENT IN NORMALIZING THE SERUM URIC ACID CONCENTRATION IN SUBJECTS WITH HYPERURICEMIA.
Status - STUDY STARTUP PHASE

Health Condition - SEMEN CHARACTERISTICS
Sponsor Location - CANADA
Study - A DOUBLE BLIND, RANDOMIZED PLACEBO CONTROLLED PARALLEL MULTI CENTRIC STUDY TO ASSESS THE EFFECT OF DIETARY SUPPLEMENT ON SEMEN CHARACTERISTICS OF HYPOSPERMIC AND NORMOSPERMIC MEN.
Status - COMPLETED THE CLINICAL PHASE, DATA MANAGEMENT ONGOING

Testimonial

“Vedic understands the intricacies of Clinical Research to ably introduce an element of innovation in the Study Design. A team of dynamic and trained personnel, who are passionate about their work and commitment to customer service. They successfully have met our project timelines”

DM Contact Management, Canada