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Which part of product development does Vedic Support?

Vedic supports clients for at all stages of the product development cycle from claim to fame: formulation development, animal studies, human volunteer studies and regulatory submissions and whatever be your quality, GMP, innovation and product differentiation need. Call us at any time for an open discussion on how we can help you grow your brand of ingredient or consumer product.

What products Vedic supports?

Food supplements, functional ingredients, dietary supplements, nutraceuticals, herbal products, natural health products, medical foods, traditional medicinal products, Chinese traditional medicines, Ayurvedic products, cosmetics, personal care/ dermatology products, stem cells therapy, medical devices, pharmaceutical and biotech products

What Label Claims Vedic supports?

Vedic helps conduct studies to substantiate structure function claims, risk reduction claims, quality of life claims, mechanism of action claims, dosage claims, target audience claims, and more…. For eg: helps in management of blood sugar levels, lowers the risk of osteoporosis, good for sports people, pre-exercise, post-exercise, general alertness at work, fatigue, etc. Vedic plans and manages research and prepares dossiers for submissions to several agencies outside of the US also.

Is the clinical data generated by Vedic acceptable in my country?

Vedic follows the ICH-GCP guidelines for generating all clinical study data. This is accepted by regulatory authorities across the globe. Vedic has successfully submitted data to Canadian, USA, EU and Far East national regulators.

Do you work/have experience with special population (Viz. pediatric, geriatric etc)?

Yes, Vedic has expertise and past experience in conducting studies on geriatric, pediatric population as well as in women.

Is there a standard patient sample size that is used for particular types of studies?

Sample size calculation is done based on the data available on the product.  In most cases Vedic suggests a minimum of 30 volunteer study to understand the product. The results of this form the basis of designing further studies for the product.

What are the regulatory requirements for conducting a human study?

Regulatory approvals are not required in the US and most other countries for the conduct of a clinical study on a nutraceutical/herbal product if it is not intended for the treatment or cure of a disease. All the studies have to be reviewed and approved by the Institutional Review Board (IRB) or an Independent Ethics Committee (IEC). Also, any clinical study has to be conducted in conformance with the ICH-GCP guidelines which is the Gold Standard for clinical studies and improves the chances of approval by most agencies including the tough EFSA. It is also recommended that the study be registered with a clinical study registry such as Clinicaltrials.gov or Clinical Trial Registry of India (CTRI) with all essential information and timely updates. Such a registry provides a unique registration confirmation number by which the non confidential details of the study and its results can be viewed.

IRB approvals and registration on a clinical trial registry lend credibility to the study and the data emerging finally and greatly enhance the possibility of approvals of papers submitted to high impact factor journals.

What is the lead time for getting a nutraceutical study approved from the regulatory bodies by Vedic?

Approvals from an Independent Ethics Committee / Institutional Review Board are received within 4 to 6 weeks.

What is your study start up time?

The study start up time is approximately 2-3 months depending upon the type and complexity of the protocol. Additional time may be taken for regulatory approvals if required.

Time for completion of studies

The study duration would depend on various factors like type and complexity of study, treatment duration, number of volunteers to be recruited, etc. On an average, studies with 60 subjects and treatment duration of 2 months can be completed in approximately 6-18 months.

Do you support in getting the clinical trials supply manufactured / imported?

Yes, we cater to all manufacturing, packaging and labeling requirements of the client for the clinical study supplies. Vedic has tie ups with contract manufacturers especially for manufacture of small batches required for clinical studies.

Do you support selling products? If so, which countries do you support sales and distribution?

Yes. Vedic can support you through the entire process of registering your product, tie ups with the sales and distribution channels in India and select Asian countries. For more details on this please contact us on: bizdev@vediclifesciences.com

What support would you offer me after the study is completed?

After study completion Vedic support clients with publication of data in international peer reviewed journals, preparation of dossiers for regulatory submissions, launching products in new geographies etc.

Do you offer any support for identification of label claims/types of packaging etc..?

Yes, We can support identifying & formulating label claims as per the regions mentioned in the answer to Q3

Would you be able to proof my label for me?

YES we can. Vedic has validated the labels for US, Canada, Mauritius, South Africa, Croatia, Thailand, Indonesia, Philippines, Kazakhstan and India

How long will it take you to send me a quotation? What kind of information I would need to disclose during the initial phase inorder to get the quotes from you?

  1. We need to understand basic information viz: nature of the product, use, dose, ingredients, objective to conduct this study.
  2. Vedic medical team then works on this information to prepare a robust, feasible study outline for the product.
  3. This is then discussed with the client for their inputs and comments.
  4. Once the Study Outline is agreed the proposals are sent to the clients within 4 working days.
  5. Vedic does not encourage but can provide“ballpark” quotations to clients who want to gauge the feasibility of conducting a clinical trial.

How confidential is my data at Vedic?

At Vedic we understand the importance of protecting the intellectual properties of our clients. Strict measures to maintain confidentiality are taken while capturing, reporting, transporting study and associated data important to our clients. Vedic has a Non Disclosure agreement signed with all employees, investigators and other site personnel.

How do you determine the cost for human studies?

  1. Our studies are priced depending upon a particular tasks we would be responsible for clinical study and the man hours that are required to complete the task.
  2. Vedic believes in leveraging in house expertise with that of the client which makes Vedic more flexible in the “task ownership matrix” thus bringing down costs wherever possible.
  3. A major cost of any human study is investigator grants. Vedic is able to keep this major cost in control by proposing sites in Asia wherever feasible to the study objectives and acceptable to clients. There are mounting reasons why India and China should be considered as potential sites for human studies for time, cost and quality reasons.
  4. Laboratory costs are planned to meet the study objectives and safety and ethical concerns in the study and mostly outsourced to labs in India which offers a huge saving as againsts such tests carried out in N. America.
  5. Another cost factor is the subject compensation which as per Indian guidelines is kept at reasonable levels so that volunteers are not enticed only by the financial motive of participation in studies.

Do you provide any certificate for the study being completed as per ICH-GCP?

  1. Yes. Vedic has an independent Quality Assurance department which assures the compliance to SOPs, GCP and regulatory requirements. This QA department issues a certificate stating that the study was conducted as per ICH-GCP standards. This is also included in the final clinical study report.
  2. Vedic also encourages and arranges for third party audits on the request of the clients.

Do you have in-house audits? Do you share these findings with the sponsor?

Yes. We do have in-house audits conducted by our Quality Assurance Dept. They can be either routine or for – cause audits. The frequency of the audits depends upon the contract with the sponsor, performance of the site and the flow of associated activities. Yes, we do share these findings with the sponsor. Significant findings are reported instantly.

What documents do you provide at the end of a human study?

A complete clinical study report (CSR) as per the ICH-E3 guidelines is provided to the sponsor. This report comprises of study synopsis, detailed study design and plan, treatment description, efficacy and safety variables, primary and secondary endpoints, evaluation scheme, complete study results with tables and graphs, discussions and overall conclusions. Original copies of the case report forms for each volunteer are also sent at the end of the study.

Apart from this regular study updates, site monitoring reports, recruitment reports are sent to the client during the study.

What are the chances of my study being published if I do it with Vedic?

Like any other research project, it is difficult to predict the outcomes of a study and whether it will be published. However, for a product with known health benefits, if the critical suggestions provided by Vedic for study design and management are followed by the client, then the chances for positive outcomes and acceptance by a high impact factor journal are as high as 90%. Vedic understands the significant resources allocated by the client company / team to a research study and also the criticality of such data to the market entry and launch of new products. Vedic team takes on all projects with a strategic long-term view of partnership rather than a one-time contract thus ensuring high success rates and minimizing risks.

What are the chances of a published study being accepted by a regulatory agency?

Again there is no guarantee how a regulatory body will view data which forms part of a published paper. Vedic team ensures high conformance with international human study guidelines even though most respected scientific journals tend to ignore certain small yet critical administrative non-compliance of the study which can sometimes become unexpected roadblocks to product approvals by agencies. So the answer: Vedic studies are planned, conducted and reported keeping in mind journals and regulators alike – always! This differentiates Vedic Lifesciences from many of the study centers that you may talk to for placing your important human study.