株式会社オルトメディコ

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Human Clinical Trial
Services

Human Clinical Trial Services

The track record of clinical
trials is proof of trust

ORTHOMEDICO leverages its
extensive experience in managing
human clinical trials (clinical trials) to propose the optimal clinical trial for each client.

The differences between us and others!
Clinical Trials by ORTHOMEDICO

Reliable and proven track record!
We have conducted 27.8% of all food clinical trials by food CROs!

In 2024, there were 270 trials conducted by food CROs.

※The term “food CRO” here refers to trial-conducting organizations classified according to ORTHOMEDICO’s proprietary criteria.

The number of published food clinical trials by food CROs
The number of publications from January 1 to December 31, 2024 (n=270)

Items Overviews
Sources of data UMIN Clinical Trials Registry (UMIN-CTR)
The date in which data was acquired January 16, 2025
Extraction procedures
  • 1. Trials published in UMIN-CTR as of January 16, 2025 (n=79,181)
  • 2. Trials that have become available to the public between January 1, 2005 and December 31, 2024 (n=79,008)
  • 3. Trials in which “Intervention” is selected as the type of trial (n=52,006)
  • 4. Trials that contain at least one “Food” as a type of intervention (n=7,571)
    * Trials that involve food intervention only (n=7,070)
  • 5. Trials that have become available to the public between January 1, 2024 and December 31, 2024 (n=643)
    * Trials that involve food intervention only (n=599)
Cleaning
  • 1. Classifying responsible organizations into the following categories: food CROs (defined as companies that is categorized as “service industries” that undertake food intervention trials), medical institutions, academia, government agencies/public corporations/organizations, for-profit companies (manufacturers, trading companies, retailers, finance, services, software/telecommunications, media), and others. (*)
  • 2. Classifying primary outcomes for trials involving only food intervention into 66 categories according to ORTHOMEDICO’s proprietary classification method. (*)
    *Please contact us for details on our classification method.

We also provide support beyond human clinical trials! We provide total support for your product development!

Developing an assessment tool for pre-disease areas!

Intuitive measurement with Rock-Paper-Scissors!
Developing the optimal assessment tool using big data and the expertise!

The flow of human clinical trials (clinical trials)

ORTHOMEDICO handles all procedures required for clinical trials—reducing the burden on your team.

Document Preparation:

the process for the Ethics Committee [approximately one month]

  • Preparation of protocols and presentation materials

  • Document preparation

  • Application to the Ethics Committee

  • Delivery of test products

Don’t worry about what documents you need to prepare. We prepare the necessary protocol in compliance with various guidelines for your product, as well as the materials needed to obtain informed consent from monitors (participants). We will then submit the application to the Ethics Committee on your behalf.

Recruitment & Implementation

Process for conducting trials [Approx. one month to six months]

  • Participants recruitment

  • Pre-study briefing

  • Screening tests

  • Main trials

Once approval is granted by the Ethics Committee, we begin recruiting monitors and start the study. It is often the hardest task to recruit participants, but ORTHOMEDICO has the know-how and experience, as we operate our own monitor registration website. This ensures a smooth study execution.

Analysis reports

Process for preparing reports [Approx. one month to six months]

  • Monitoring

  • Data management

  • Statistical analysis

  • Writing a report

We input, check, and analyze valuable test result data, summarize the study findings and discussion, and write a report. Our all-in-one system, which handles everything up to this stage, significantly accelerates the speed of your company’s product development.

Regarding human clinical trials (clinical trials)
Contact us here

Human Clinical Trial Services

We enhance efficiency through analytical consulting. Statistical Analysis Services

We have launched a contract service specializing in data management and statistical analysis. We handle a wide range of services, from practical operations to consulting work such as developing analysis plans.

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Leave the finish of your research to us Comprehensive Manuscript Preparation Services

We handle all aspects required for academic paper submission: ① Journal selection, ② Manuscript writing, ③ Submission procedures, ④ Reviewer response support, and ⑤ Post-acceptance procedures.

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Human Clinical Trials (Clinical Trials) and Various Support services

Please feel free to contact us with any inquiries.