Clinical Development (Sponcer)
- Medical Devices
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.
Confirm whether the medical site has sufficient capacity to conduct clinical trials.
The requirements specified in GCP are confirmed with the medical sites and the investigators.
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.
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.
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.
- 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.
Micron is actively involved in clinical trials of medical devices. In order to utilize Micron’s image analysis technology and monitoring know-how in medical device development, we established a Medical Device Development Support Office in Tohoku University Hospital.
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)
- IWRS (Interactive Web Response System)
- DM/Stastic Analysis
- Case Study Meeting
- Creation for Case Study Report
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.
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™
*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 is here to manage your Imaging Contract Research Organization (iCRO) needs. Micron’s mature imaging processes take the worry out of clinical trials imaging requirements. Micron manages imaging for clinical trials globally, including the Asia Pacific region, with unparalleled cultural and language ingenuity. In the iCRO world, Micron delivers regulatory rigor, a deep global presence, renowned expertise, years of wisdom and training in many therapeutic indications, imaging modalities and assessment criteria. Our top-notch qualified experts have managed the risks in imaging and image-analysis for multi-site global clinical trials for decades.