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
- Patient Registration Center
- DM/Stastic Analysis
- Case Study Meeting
- Preparation of Clinical Study
Report (Investigator-Initiated Trials)
- Paper Writing (Clinical Research)
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.
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
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.
Monitoring by Imaging CRA™
*We expect studies in which the primary endpoint is imaging for this category.
Non-Imaging CRAs apply)
*We expect studies in which imaging sites are different from the sites where clinical trials are conducted.
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.
Imaging ServicesCentral Review Management and Support / Image Analysis/ Consulting
Clinical DevelopmentMedicine / Medical Equipment / Company-Sponsord Clinical Trials / Monitoring
Investigator-InitiatedInvestigator-Initiated (Clinical) Trials
SupportLaunch and operation support for PET investigational drug manufacturing facilities
Quality AssuranceConsignment Audit / Internal Audit
Products & ServicesDevelopment of imaging biomarker / Image analysis software / NPI