Full support from early development through regulatory submission
We can flexibly provide services from partial trial outsourcing to comprehensive support for the entire development process.
We provide comprehensive, one-stop services for all clinical development needs, with experienced project managers collaborating closely with each specialized department. The Imaging CRA® system assigns highly knowledgeable CRAs, enabling smooth collaboration with the imaging department and rapid responses to queries.
Imaging-Based Monitoring for Clinical Trials “Imaging CRA®”
Imaging CRA®
As an imaging CRO, we foster the development of “Imaging CRAs®,” professionals who possess deep expertise in imaging technologies such as PET and advanced monitoring methodologies.
“An Imaging CRA® not only possesses a thorough understanding of medical and pharmaceutical sciences as well as various regulatory guidelines ,but also has specialized expertise in imaging, enabling smooth site start-up.
Furthermore, by leveraging our experience and adopting risk‑based monitoring (RBM) for imaging studies, we proactively identify imaging‑specific risks and ensure clinical trial quality efficiently and effectively.
Clinical studies involving PET have unique characteristics and differ in several important ways from studies that do not involve PET imaging.
Clinical trials utilizing PET require additional monitoring activities beyond those of conventional studies. Micron’s CRAs possess specialized training in imaging for clinical trials, enabling them to provide high‑quality monitoring services.
FAQ
Micron is primarily an imaging-focused CRO, but our services are not limited to clinical trials that use medical imaging. Regardless of whether imaging is involved, we provide flexible support tailored to the specific characteristics of each study.
We were founded as Japan’s first imaging CRO and have led the domestic market in clinical development using molecular imaging techniques that are widely used in Europe and the United States. Through these efforts, we obtained the trademark registration for ‘Imaging CRA®.’ in 2005.
We specialize in study monitoring using imaging technologies, but we also have experience in handling several other types of studies and are fully capable of Supporting them.
Imaging diagnostics are used as objective evaluation metrics in the form of imaging biomarkers, contributing to highly objective clinical data analysis for drug efficacy assessment and clinical trial planning. We also have extensive experience in statistical analysis for Software as a Medical Device (SaMD), including AI‑powered diagnostic imaging applications. We provide consistent statistical support throughout all stages of the clinical development process, from early-phase planning to late-stage analysis.
We provide support for study design and analysis from a statistical perspective. We can be involved from the planning stage, including assistance with study design and sample size calculations.
Micron’s DM supports not only EDC development but also a wide range of data formats, including CSV, SAS data, DICOM, and JSON. We can also handle video and image data and can propose solutions using our in‑house system, IRUM®neo. In addition, we have a proven track record in emerging fields such as SaMD and DTx
We carefully assess and understand each client’s needs and incorporate them into the overall study design while considering relevant regulatory requirements. Based on this, we provide medical writing support with a clear focus on future regulatory submissions. Another strength is our ability to collaborate with related functions, such as statistical analysis, data management, and regulatory affairs, to prepare documentation that ensures consistency throughout the entire study.
We are fully able to assist you. We provide support from the pre‑protocol development phase, helping you consider the overall study design and regulatory requirements to prepare high‑quality documentation. We are also available to assist with specific writing tasks, including drafting or reviewing individual documents. Please feel free to contact us at any time.
We provide support for the preparation and review of a wide range of clinical development documents, including study protocols, protocol synopses, informed consent forms, various standard operating procedures, clinical study reports, and regulatory submission materials.
We are fully able to assist you. We support industry‑sponsored clinical trials, investigator‑initiated trials, and clinical research, from early development through regulatory submission. We can also serve as a Clinical Trial Coordination Office or Research Administrative Office.
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If you are considering clinical development, please feel free to contact us.
Please feel free to contact us
We provide comprehensive, end‑to‑end clinical development support, with imaging at its core.
With more than 20 years of experience, our team of imaging specialists in Japan and around the world tackles the complex challenges of imaging evaluation in pharmaceutical and medical device development. We deliver optimal, project‑specific solutions for each client.