Natural and Nutrient Product Clinical Trials --
Supporting the Welllness Industry

New Services from NCT:

[1] EU Cosmetic Product Information File (Dossier) with new Slide Presentation and Webinar:
Click Here.

[2] Institutional Review Board (IRB) Services for Clinical Trials: Click Here.

[3] Without Adequate Clinical Trials, your Company may not be in Business in Two Years... Start your Clinical Trials NOW!

Interview with Dr Jay Udani - CEO, Medicus Research By Stephen Daniells, 27-Oct-2010:

"At the ... SupplySide West show in Las Vegas, Dr Udani, also an associate clinical professor at UCLA, explained that companies can no longer piggy-back on the science of others, and must undertake clinical trials now. 'In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today,' said Dr Udani."

New FDA and FTC regulations make your job harder than ever... Recent changes mean that your Nutrient or Natural Product company MUST expeditiously complete Clinic Tests, Studies and Trials:

  • To demonstrate product safety
  • To substantiate product claims
  • To determine "typical results" for Testimonial Ads
  • To meet batch testing requrements.

  • These changes also mean you must not:
  • Make claims you cannot substantiate
  • Use Testimonials without disclosing "typical results"

What can you do to tell your customers that your Nutrient or Natural Product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...

With these restrictive regulations in place, what CAN you tell your customers to let them know that your product is helpful, effective and important for them to use?

With our decades of experience in regulatory, clinical and scientific practice, NCT's principals can answer that question for you!




Natural Solutions Center, Volcan, Panama

Introduction


NCT, the Nutrient and Natural Clinical Trials program, a unit of the Natural Solutions Center, was established to bring our special expertise to natural product clinical studies, tests and trials. The Natural Solutions Center in Volcan, Panama is now OPEN and therefore NCT is open for business! See the Grand Opening Videos: http://www.healthfreedomusa.org/?p=6069

From NutraIngredients-USA: "Dr Jay Udani... gave us his 5 secrets for clinical trials success... At the ... SupplySide West show in Las Vegas, Dr Udani ... an associate clinical professor at UCLA explained that companies ... must undertake clinical trials now."

To see this important 5 minute interview, Click Here.


Natural Solutions Foundation (NSF), founded in 2004, is an international NGO (Non Governmental Organization) focused on discovering, documenting, developing, demonstrating and disseminating natural solutions. We are active and registered in several countries and a not for profit 501(c)(3) tax exempt organization in the United States.

Since its founding the Natural Solutions Foundation has pursued a vigorous program on many fronts, including the development of an advanced healthcare clinic in the beautiful, bountiful, temperate Highlands of Chiriqui Province, Panama.

The NCT program is headed by Rima E. Laibow MD, with the collaboration of Robert M. Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff. To review the Vitae of the three Co-Directors: Click Here.

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FDA Guidance

In its recent Guidance for Industry: Substantiation for Dietary Supplement Claims, the FDA tells us its views regarding clinical studies, trials and tests.

"What is the Substantiation Standard?

"The FTC standard of competent and reliable scientific evidence has been defined in FTC case law as "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."

"Although there is no pre-established formula as to how many or what type of studies are needed to substantiate a claim... [FDA] like the FTC, will consider what the accepted norms are in the relevant research fields and consult experts from various disciplines. If there is an existing standard for substantiation developed by a government agency or other authoritative body, we may accord some deference to that standard.

"In determining whether the substantiation standard has been met with competent and reliable scientific evidence, we recommend that firms consider the following issues in their assessment:

1. The meaning of the claim(s) being made;
2. The relationship of the evidence to the claim;
3. The quality of the evidence; and
4. The totality of the evidence."

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NCT - Nutrient and Natural
Clinical Trials Program

State-of-the-art clinical trials, tests and studies...
www.NutrientClnicalTrials.com - www.NaturalClinicalTrials.com

This joint venture of the Natural Solutions community in Panama is pleased to be able to make available to private companies our advanced clinical study program, designed to meet FDA and FTC requirements. All nutrient and natural product companies need affordable, competent and expert clinical trial services. United States and European natural product companies have long been among the most innovative in the world. However, today they are faced with rapidly increasing regulations and costs. Among the most important of these are testing and clincial study costs.

In the United States these are specially associated with the Current Good Manufacturing Procedures (CGMPs) required under FDA regulations and the revisions in the Testimonial Rule by the FTC which, as a practical matter, mandates clinical trials if companies want to use testimonials in advertising, since, under the 2009 rule, it is no longer sufficient to disclose to potential customers that testimonial "results are not typical..." In addition, companies must be able to determine "typical results" -- only possible if proper tests and clinical studies or trials are conducted in a controlled environment. And that is exaclty what Natural Clincal Trials is set up to do for you.

The NCT Clinical Trials Program is located off-shore at the Advanced Healthcare Clinic in lovely Volcan, Panama under the direct personal supervision of Dr. Laibow.
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Becoming an NCT Client

There are three simple steps to you NCT Clinical Trial.

1. Complete the Private and Confidential Potential Client Online Questionnaire, Click Here.

2. Review & Approve NCT's Client Proposal.

3. Refine your Claims Message through consultation with our scientists and advisors and approve the Clinical Trials Protocol for which you will provide the test samples (your products) and, where needed, placebos.

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How Soon Will My NCT
Clinical Trial Be Completed?

In general, clients take between 4 and 6 weeks to complete the first three steps.

NCT will require between 2 and 4 weeks to schedule and begin your Clinical Trial.

The nature of the claims to be evaluated will determine the time required and number of participants.

Clinical trials may include several dozen participants and may take between 6 and 8 weeks to complete, including before-and-after biological marker testing individualized for your Clinical Trial Protocol.

To recap: start here: Online Quesstionnaire

  • Fill out the no obligation, free Client Questionnaire.

  • There is no charge for this step and no obligation.

  • Once you complete the Client Questionnaire you will receive your NCT Initial Clinical Trial Proposal.

  • The Final Clinical Trial Report, authorized & signed by our team of Directors, will be in your hands in 4 to 6 weeks after completion of the Clinical Trial Study.


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Site Use Disclosures and Disclaimers

Private discussion only . . . The within is a confidential, private expressive association transmittal, submitted without prejudice and with full reservation of rights. Not intended to diagnose, prescribe for, treat or claim to cure, mitigate or prevent disease conditions.

For our complete disclosures and disclaimers see: Site Use Statement. Index

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