Clinical Development (Sponsor) – Pharmaceuticals –


Micron’s CRAs are a group of specialists who not only have a thorough knowledge of various guidelines necessary for monitoring, such as basic medicine and pharmacology, and GCP ministerial ordinances, but also have advanced communication skills, management skills, data analysis skills, language skills, and so on, and each CRA has his or her own strengths. In order to conduct high-quality clinical trials on schedule, we are promoting monitoring by making use of a check function across the Group. The Senior CRA performs cross-site performance checks at all facilities and Action Plan (S-TOP: Situation, Target, Option, Plan) checks to achieve case entry goals.






Feasibility Survey

Confirm whether the medical site has sufficient capacity to conduct clinical trials.

Site Selection

The requirements specified in GCP are confirmed with the medical sites and the investigators.

Site Initiation

After the site/investigator’s selection is completed, the protocol is agreed upon with the investigator and a designated document is submitted to the IRB/IEC through the director of the medical institution to review the conduct of the trial. After approval by the IRB, a contract is entered into with the medical institution, and a meeting is held in order to ensure the understanding and consensus of all clinical trial staff at the medical institution.

Interim Monitoring

For the site monitoring phase, CRAs conduct monitoring activities to improve the reliability of the data, such as checking that the clinical trial is conducted in accordance with the protocol.

Site Closure

For Site Closure, CRA will collect the investigational product, confirm the completion procedure at the medical institution, and confirm the status of documents related to the clinical trial are recorded properly.

Micron is a highly flexible CRO based in Tokyo and Osaka. This is why we have achieved results that exceed the expectations of our clients and medical institutions through good communication and project management based on individual CRAs. As an imaging CRO, we are also developing human resources with expertise in PET and other imaging technologies and monitoring techniques, which are expected to be in demand in the future.

Quality Control

  • Review and management of clinical trial documents
  • Review and management of clinical trial data and CRFs
  • Protocol review

Micron’s Quality Control Group is well versed in GCP, other clinical trial guidelines, pharmaceutical regulations, and has a wide range of experience. Our Quality Control Group works with the monitoring staff to provide rigorous quality control of relevant documents and data to ensure the reliability and sufficient service of clinical trials. We are also working to improve knowledge and technology related to quality control through the activities of the Japan Society of Quality Assurance.

At Micron, we will act as a sponsor in Japan on behalf of pharmaceutical companies that have not established a corporation in Japan.

CRO service including ICCC

Monitoring by Imaging CRA

  • Feasibility for Imaging Sites,
  • Meeting for Imaging Protocol for each Department
    (Department of Radiology,
    Clinical Trial Office)
  • Query Correspondence
    Data Lock
  • Close Out

Proposal Results

Clinical Trials with Imaging Compatible Type
Assigned as CRAs who are in charge of sites (Only Imaging CRAs apply)
*We expect studies in which the primary endpoint is imaging for this category.
Clinical Trials with Imaging Function Added Type
Assigned as CRAs who are in charge of sites are located separately (Imaging CRAs and
Non-Imaging CRAs apply)
*We expect studies in which imaging sites are different from the sites where clinical trials are conducted.