CNDSR
Frequently Asked Questions
A step-by-step overview can be found HERE.
The CNDSR supports companies at most stages of product development/testing, from assay
development, to proof-of-concept animal studies, to full scale human clinical trials.
A list of services can be found HERE.
First, note that a non-disclosure agreement is often signed prior to any discussions
taking place. For the most accurate quote, the CNDSR would need to understand basic
information including the nature of the product to be tested (i.e., proposed use),
outcomes measures to be included, sample size, and timeline. Our team will then consider
this information in developing a study scope of work. This will be discussed with
the company. Once the scope of work is agreed upon, the budget can typically be provided
to the company in less than one week.
Details related to intellectual property are defined within the contract. The company
retains rights to all intellectual property that was owned by the company prior to
project initiation.
Studies conducted in the CNDSR are more affordable than you may think. The cost varies
depending on the nature of the design. Some small-scale pilot (proof of concept) projects
may cost less than $20,000, while more complex human clinical trials may be considerably
more. The main variable influencing project cost is sample size (number of subjects
or animals) and outcome measures included. We encourage companies to contact us to learn how affordable a high quality project can be.
Approval from the IRB or IACUC typically takes between three and eight weeks from
the time of initial protocol submission.
Depending on the type and complexity of the protocol, the study can usually begin
within three to eight weeks of contract execution. This timeline assumes on-time approval
of IRB or IACUC protocols. Experiments that do not involve human subjects or animals
may be started even sooner.
A complete study report is provided to the sponsor, often in the format of a scientific
manuscript. This report is comprised of the study synopsis, detailed study design
and plan, treatment description, efficacy and safety variables as appropriate, outcome
variables, analysis, complete study results with tables and figures, discussion, overall
conclusions, and references.
As an independent third party research group, we do not endorse or sell any nutraceutical
or dietary supplements direct to consumers.
