Micron

Investigator-Initiated Clinical Trials

Micron is actively engaged in investigator-initiated clinical trials and clinical research, and has experience in all fields of pharmaceuticals, medical devices, and regenerative medicine. We can support a wide range of activities from monitoring and planning of clinical trials to report preparation.

  • Consultation for Clinical Trials
  • Preparation of various documents (Protocols, etc.)
  • Clinical Trial Notifications Preparation Support
  • Monitoring
  • Patient Registration Center
  • DM/Stastic Analysis
  • Case Study Meeting
  • Preparation of Clinical Study
    Report (Investigator-Initiated Trials)
  • Paper Writing (Clinical Research)
Monitoring by Imaging CRAs

Clinical Trial Consultations

Clinical trial consultation support

For investigator-initiated clinical trials, Micron support applications for clinical trial consultations, preparation of required documents, attendance at clinical trial consultations, and response to inquiries.

Evaluation method consultations

When using imaging to evaluate the efficacy and safety in clinical trials, Clinical Development Support Department collaborate with our Imaging Service Department to provide comprehensive support from the proposal of evaluation methods to interpretation meetings (Result report of imaging evaluation).

Preparation of various documents (Protocols, etc.)

A variety of documents will be prepared, including protocol, IB, sample Case Report Form, and ICFs. In addition, Micron can prepare procedural manuals and manuals such as those for the preparation and revision of investigational products/investigational equipment management procedures and Case Report Forms.

Clinical Trial Notifications Preparation Support

Micron can prepare Clinical Trial Notifications for investigator-initiated clinical trials and submit them to PMDA（Pharmaceuticals and Medical Devices Agency）. When there is a change in the items to be reported, a notification of change is made and submitted, and when the clinical trial is completed, a notification of completion is made and submitted.

Monitoring

Micron has experience with many types of monitoring.Click here for details of the monitoring.

Patient Registration Center

Register by fax or by using the patient registration system (Interactive Web Response System). Patients are registered after confirming that they meet the inclusion criteria specified in the protocol and do not meet the exclusion criteria.

DM(Data management)/Statistical Analysis

Working with a dedicated CRO, Micron provide full support from preparation of Case Report Form to analysis report preparation.

Case Study Meeting

Documents preparation

We have compiled information on cases that need to be handled at case study meetings to facilitate smooth case review meetings.

Provision of venue

Micron can be used as a venue for the case study meeting.

Preparation of minutes

We will prepare the minutes of the discussion at the case study meeting.

Preparation of Clinical Study Report (Investigator-Initiated Trials)

Micron will prepare the final report. Micron has produced Clinical Study Reports in clinical trials of medical drugs and medical devices.

Paper Writing (Clinical Research)

Micron can provide papers based on the results obtained from clinical research.

CONTACT ARCHIVEMENT

Monitoring by Imaging CRA™

  • Feasilibility for Imaging Sites,
    Modalities
  • 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.

SERVICES

Micron, with Imaging CRA ™ and Japan's largest medical imaging analysis team, has accumulated the know-how to utilize medical imaging at the endpoint of clinical trials and supporting various clinical trials by closely communicating with domestic and foreign KOL or experts. We are promoting the systematization and develpment of medical image analysis software, including the expanding of capabilities, and recommending optimal clinical trials as a pioneering Imaging CRO.