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Contract Research

Helfgott Research Institute receives many requests from nutriceutical, herbal medicine, probiotic and medical device companies to conduct research on their products. Our investigators are skilled at testing natural medicine products used in clinical practice and are passionate about contributing to the evidence base for natural medicine. We adhere to the principle “first, do no harm” and will not conduct research on products that we deem to be unsafe. Additionally, we do not conduct animal studies.

We specialize in clinical trials and our investigators have been trained in natural and integrative medicine research design. We understand the challenges that are unique to natural products and integrative medicine, and we are prepared to overcome those barriers. With extensive experience in conducting successful natural medicine projects, we are prepared to offer companies a highly qualified and responsive research team to develop a clinical study that can be used to market their product and fulfill FDA requirements.

The cost of conducting professional clinical research is high. Planning for a research project requires planning a budget that will meet the individual needs of the company. While we cannot predict the how much a given project will cost until we develop a study design with the company, the following estimates are provided as general guides.

Cost Estimates

IRB Review

  • Approximate cost: $5,000
  • Time frame: 2-3 months
  • Required for all studies involving human subjects

Literature Review

  • Approximate cost: $20,000
  • Time frame: 4-6 months
  • Comprehensive database search for current and past relevant research literature
  • The final product is an annotated abstract or a literature review for publication in a journal or magazine

Pilot Study

  • Approximate cost: $70,000
  • Time frame: 6-12 months
  • Part-time project coordinator
  • Study design (10 participants or less)
  • Protocol documents
  • IRB submission and review
  • Study intervention
  • Data collection
  • Data management
  • Does not include laboratory testing or data analysis

Clinical Trial

  • Approximate cost: $120,000 – $200,000 per year
  • Investigative team
  • Study design (minimum number of study participants to achieve statistical significance)
  • Protocol documents
  • IRB submission and review
  • Advertising
  • Study intervention
  • Laboratory testing (varies)
  • Data collection
  • Data management
  • Data analysis (biostatistician)
  • Final manuscript for publication