NCT Potential Client Questionnaire

Private and Confidential Questionnaire.

Full name:
Company name:
Product or service:
Website URL:
E-Mailing address:
Phone number:

1. Please provide budget guidance for us: does this product, or is it expected to, generate sales of (a) less than $100,000 per year; (b) more than "a" but less than $500,000 per year; (c) more than "b" but less than 1,000,000 per year or (d) more than $1,000,000. Expenses of studies of different power can differ by severalfold and we need to be able to advise you on your possible range of services. This information will be held in strict confidence.


2. What type of product is are you considering? Is it one whose benefits should be expected quickly, or slowly? Is it to prevent certain harms, or is it to produce positive benefits? Is it useful for all ages and both sexes equally, or primarily or exclusively for only a certain subset of the population?


3. If your product is designed to produce benefits or reduce harms, are those benefits or harms easily direclty measurable directly? How is that measurement done? If not, are there surrogate measurements available which gives us reason to believe might be good predictors of these benefits or harms?


4. Do you believe that these directly measured benefits or reduction in harms, or surrogate measurements, can be stated directly in the advertising of the product in ways that will not put the product into a more stringent regulatory category? Our services may help you determine this issue.


5. What is your time line to have these results?


6. Do you believe that a double blind study woudl be possible using your product? Some products may reveal their presence in ways that make it futile to attempt blinding, or which make blinding more of a challenge. If your product is such a substance or technology, do you have any ideas on how blinding could be accomplished?


7. Do you intend to submit the study for publication or to a regulatory body once it is completed?? If so, certain requirements should be anticipated in the study design which could be avoided if the study were not desiged for regulatory or publication dissemination.


8. 8. Have you done prior studies on this product? What type and what were the results? What customer feedback and ancedotal information do you have?


9. Have you filed any structure and function claims notices about these products? Please list claims language and indicate whether FDA responded to the notice; and if so, what was stated?


10. What claims do you hope to be able to make after the study is concluded?


11. Have you done, or are you aware of, any prior clinical trials on this product or its major ingredients? Please give citations or details.


12. Have you been noticed by the FDA or other agency about any deficiencies, labeling irregularities or other problems with this product? Please specify.


13. Trademarks of products to be studied with brief description of each. Are any trademarks registered?


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