What is a clinical trial?

A clinical trial in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes, obtaining evidence on the safety and efficacy of the product of concern. And particularly, performing trials evaluating the effect of interventions using functional food on volunteers of sub-optimal health is a strength of ours.

Why is obtaining scientific evidence so important?

Scientific evidence can be used to clear out ambiguity. Obtaining scientific and objective evidence is the answer to all ambiguity pertaining safety and efficacy of your product. Any company can make any form of statement relating to the safety and efficacy about their product, but without scientific evidence to back up such statement, its validity and accuracy are questionable.
For example, a claim about the effectiveness of a dietary supplement from a friend, a relative or even a physician is nothing more than an opinion without evidence.

Types of trials we perform

• Type of trial

  • ・Safety(Long-term / Over-dose)
  • ・Efficacy
  • ・Dose-finding
  • ・Bio-equivalence

• Blinding

  • ・Open-label
  • ・Single-blind
  • ・Double-blind

• Group

  • ・Single-group
  • ・Multiple-group

• Design

  • ・Before-after trial
  • ・Randomized Controlled Trial (RCT)
  • ・Cross-over trial

We, ORTHOMEDICO, support our clients in obtaining evidence through the following:

• 1.Writing protocol
• 2.Participant recruitment and management
• 3.Scheduling management
• 4.Data Management
• 5.Data Analysis
• 6.Making presentation and publication

The Process of Acquiring Evidence

The steps for evidence acquisition include:

1. 1.Preclinical studies

   Preclinical studies are performed to verify the safety and efficacy of food in vitro and in vivo.

2. 2.Dose-ranging study

   Dose-ranging studies are conducted to determine the most effective dose through consumption of food by participants at different quantities.

3. 3.Safety evaluation studies

   ①Safety evaluation study via multiplied dose consumption

   In this study, participants are instructed to consume the test food at a quantity which is 3 to 5 times of the usual quantity for a specified period of time. Adverse events are recorded to assess safety.

   ②Safety evaluation study via long-term consumption

   In this study, participants will consume the test food at the usual quantity for a long period of time (>3 months). Adverse events are recorded to assess safety.

4. 4.Efficacy study

   Efficacy studies are conducted to verify the effectiveness of the functional foods on human

Outline of Clinical Trial Service

We, ORTHOMEDICO, support our clients throughout the entire process from establishing a protocol to making a presentation at a conference.

Clinical Trial in Humans

About 1 month

Preparation and Institutional
Review Board

1. Trial material and protocol writing
2. Participant information preparation
3. IRB evaluation
4. Ordering of test product

About 1 to 6 month

Trial Conduction

1. Participant recruitment
2. Briefing session and screening
3. Start and monitoring of trial

About 1 month

Data analysis & Reporting

1. Data management and statistical analysis
2. Report writing

Result presentation and article publication

Under the “foods with functional claims” system of Japan, food products with scientifically proven health claims labelled on their packaging can be sold as long as the food provider takes full accountability. However, before introducing such product into the market, in regards to the safety and efficacy information, required documentation must be prepared, information must be presented in a specified format and a notification has to be sent to the Secretary General of the Consumer Affairs Agency (CAA) of Japan.

When evaluating and explaining the functionality of a food product, there are 2 possible scientific methods. The first method is to use the result of a clinical trial where the food in its final product form was studied. The other method is to conduct a Systematic Review by gathering literatures and assessing the product comprehensively while following a set of established rules. As we, ORTHOMEDICO Inc., have experience in both methods, anyone regardless of their experience in the field can rest assured and leave it all to us.

Features of this service:

• ・Back you up on legal proceedings for administration purpose
• ・Support in obtaining scientific evidence which suits best to the requirement stipulated by the foods with functional claims system of Japan
• ・Writing protocols for Systematic Review and, qualitative and quantitative evaluations on data obtained from studies
• ・Formulated search statement, literature review, appraisal to the contents of literature and legal support.
  We provide support and execute on behalf of our client everything from clinical study to submission of notification to CAA and any other related tasks after acceptance

In ORTHOMEDICO Inc., a self-run website known as “GO106.jp” is used to recruit participants for clinical studies. In order to enhance the evaluation of safety and efficacy of food products, and improve the quality of studies, it is of paramount importance only the most suitable test participants are chosen for each respective study.
By providing free events such as health checks, bone mineral density assessments, and blood sugar tests, we are able to constantly update our database and hence have a full picture of the participants registered in our system. This enables us to find the most suitable group of candidates for each individual clinical study.

Number of registrations to our system has increased year by year. Presently, no less than 50,000 candidates have already registered to the system!!

Thumbnail examples of our recruitment advertisement

When developing a new product, a great variety of factors from the dietary preferences to the lifestyles of consumers, together with their health conditions and nutritional statuses must not be overlooked. Due to the regular participation of individuals who are registered to our Go106.jp participant recruiting system in studies related to health products and cosmetics, many of them have become highly health- and beauty-conscious. Through the appraisals and criticism by these keen-eyed individuals, many of our clients’ products which are under development have been further refined.
We, ORTHOMEDICO, provide the very platform for companies to obtain first-hand consumer opinions through means of surveys and opinion sharing sessions. This information, we believe, can be used to further promote the development and marketing of your products.
In addition, being one of our important strengths, the analytical skill in data science we have acquired over the years of conduction of clinical studies enables us to deliver results viewed from multiple-perspectives.

Highlights from a product opinion session (Fragrance preference survey)

We offer support to activities that aim to deepen and broaden one’s knowledge on the basis of medicine and nutritional science. Specifically, we do so by holding study groups and research seminars, and building bridges between businesses and clinical medical practitioners and those between businesses and academia. Presently, a large number of researchers and clinicians have been registered to our system. Specialists in their respective field are also invited regularly to make presentations in study groups. For food companies, this not only boosts the consumers’ confidence on their product, but also serves as a great public relation activity.

Symposiums organized by ORTHOMEDICO