Clinical Development (Sponsor) – Medical Devices –

Micron is actively involved in clinical trials of medical devices. Unlike pharmaceuticals, medical devices vary in form and performance, Therefore, it is necessary for the sponsors themselves to decide how to evaluate efficacy and safety according to the type of medical device they are developing. We propose an image evaluation method (PET, MRI, etc.) that has recently been adopted as a method for evaluating the efficacy and safety of clinical trials.

  • Consultation for Clinical Trials
  • Creation Support for Documents (Ex: Protocol)

  • Monitoring
  • IWRS (Interactive Web Response System)
  • DM/Statistic Analysis

  • Case Study Meeting
  • Creation for Case Study Report

Monitoring by Imaging CRAs

Consultation for Clinical Trials

Clinical Trial Proposals

We propose methods for evaluating the performance and risk of medical devices. When an evaluation using images is appropriate, we cooperate with the Image Analysis Division to provide comprehensive support from proposal of evaluation methods to interpretation meetings (Report of image evaluation).

PMDA Consultation Support

We support applications for clinical trial consultations, preparation of necessary documents, participation in clinical trial consultations, and response to inquiries.

SOP Creation Support

Sponsors conducting clinical trials must prepare SOPs for trial-related work and clarify their roles and work procedures. At Micron, we review the client’s internal organization, and propose an SOP meeting the internal procedures.

GCP Training

Sponsors conducting clinical trials must sponsor and manage clinical trials in compliance with GCP. Micron conducts GCP training for clients conducting clinical trials for the first time.

Monitoring by Imaging CRA™

  • Feasibility 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.

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