Scope of Work
What we do, and what we do not
Working principally on ginseng, red ginseng, medicinal plants and functional foods, we cover the whole path from design to publication. What follows sets out both the range of that work and its limits.
Human trials for functional ingredient approval
We design and conduct human trials aimed at approval of a health functional food ingredient. This includes:
- Selection of a primary efficacy endpoint appropriate to the target function, with supporting rationale
- Power analysis and sample size calculation based on prior data
- Bias-control design — randomisation, double blinding, placebo control
- Inclusion and exclusion criteria, dose and duration, visit schedule
- IRB support — protocol, information sheet and consent form, case report forms, recruitment notices
- Conduct and monitoring, adverse event collection and reporting
- Statistical analysis according to the pre-specified plan
- A study report in a form usable as part of an approval dossier
Exploratory and confirmatory trials
We design and document exploratory and confirmatory clinical trials.
- Protocol design — hypothesis, endpoint hierarchy, study duration, interim analysis plan
- Statistical analysis plan (SAP) — analysis populations, missing data, multiplicity, sensitivity analyses
- Randomisation scheme and allocation concealment procedures
- Clinical study report (CSR)
- Where regulatory submission is the aim, documents structured to the required format
For trials of medicinal products, the qualifications of the investigator, the study site and the approval requirements are set separately by law. The institute performs the design, statistical and documentation work; site requirements are reviewed together at the consultation stage.
Animal, cell and compositional work (partner facilities)
Studies requiring specialist facilities are contracted to partner organisations; the institute handles design, interpretation and documentation.
- Animal studies — model selection, group structure, dose setting, interpretation
- Cell studies — in vitro designs to establish the mechanism of action
- Compositional analysis — HPLC quantification of marker compounds, batch uniformity
- Building the chain of evidence before a human trial — composition, cell, animal, human
Publication, reports and grant proposals
- SCIE submission — English manuscript, journal selection, submission, peer review response, resubmission
- Re-analysis and publication of data you already hold
- Research reports — internal corporate reports, final project reports
- Grant proposals — research plans for government and corporate funding
- Review of prior work — systematic literature review and grading of evidence
Citations and references follow APA 7th edition, and claims that cannot be substantiated are not included.
Principal materials
Ginseng and red ginseng
White, red, black and fermented red ginseng, ginseng extracts and ginsenoside-enriched preparations.
Medicinal plants
Single and combined extracts of plants with a history of traditional use.
Functional food ingredients
Health functional food ingredients, their combinations, and functional materials in food form.
What we do not do
The institute is not a medical institution. We do not provide consultation, prescription, or the diagnosis and treatment of disease, and we do not give medical advice or treatment recommendations to individual patients.
- We do not fix a conclusion in advance that a product prevents or treats disease and then assemble data to match it.
- We do not use wording in reports or papers that goes beyond what was observed, or that would fall foul of labelling and advertising review standards.
- We do not collect data from human subjects without IRB approval.
- We do not change the analysis plan in a favourable direction after seeing the data.