Services

MicroMRI provides contract research services for quantification of changes in bone micro-architecture during drug treatment in clinical trials. Our patented MRI technologies enable examination of the human wrist or ankle in microscopic resolutions, and collecting of quantitative markers of bone quality in addition to bone volume. This facilitates early and sensitive tracking of disease progression and therapy effects in very small groups of patients. Peer reviewed publications show that our technology provides value in clinical trials over and above what is currently available using DXA (Dual Energy X-ray Absorptiometry). This could enable much more cost-efficient trial design, progression and facilitate targeted treatment. This in turn can lead to bringing your compounds to market faster.
MicroMRI provides guidance and assistance in study design modules that relate to our technology, and can also provide support spanning the entire clinical trial process.
Our clinical protocols are developed by Dr. Michael Kleerekoper, an expert clinician and researcher with over 35 years of experience in running large, multi-center clinical trials on behalf of pharma and NIH.
  • We provide training of site personnel for site installations, acquisition, Quality Control and transmission of data.
  • We provide proprietary and validated MR coils for imaging of micro structures.
  • Clinical trials data are analyzed with our proprietary, patented and validated software.
  • Analysis results are delivered to the client in a mutually agreed custom form.
  • Investigators can document trial procedures, readers can process and analyze images and clients can review reports, all from the convenience of their individual work stations.
Quality Assurance
MicroMRI’s internally developed quality control tools and processes are optimal for multi-center trials.
  • Our unique anthropomorphic MRI phantom verifies adequate signal generation.
  • Our immobilization and localization procedures ensure returning to the exact same site, invaluable for longitudinal trials.
  • Our validation protocols, designed to limit variability, have been thoroughly tested, and any inherent errors in measurement are quantified and can be integrated into study design.
  • Our remote diagnosis system handles possible site malfunctions efficiently and effectively. In case a solution cannot be found remotely, an engineer or project manager can be on site within 24 hours to resume trial performance.
  • Quality control checkpoints are established and documented for:
    • All steps of the on-site process, from site installation to data transfer to MicroMRI.
    • In-house data handling
    • Processing of results
    • Handling and archiving of data
    • Reporting to client

Regulatory Compliance

Our HIPAA policy ensures that electronic systems and personnel handle personal information according to HIPAA regulations.
  • Our on-site and post processing software are validated according to FDA regulations and software engineering standards.
  • Our coils are designed and manufactured following cGMPs.
  • Our network of servers, redundant backup systems, audit trail, fire alarms, building security and disaster recovery plan ensure business continuity, security and data integrity in compliance with cGCPs, 21CFR part 11 and HIPAA.
  • All on-site and in-house data handling are done according to FDA regulations.
Trial Centers
The MicroMRI technology, is currently installed in premier medical facilities both domestically and internationally. Representative sites include the University of Pittsburgh, the University of Arizona, the University of Medicine and Dentistry of New Jersey, Brigham and Women’s Hospital, the University of Colorado University of Cincinnati and the Instituto de Investigaciones Metabolicas in Argentina.  MicroMRI is able to install its technology at almost any whole-body MRI scanner (1.5T and above), allowing a pharmaceutical company flexibility to designate the best enrolling trial centers. Additionally, since MicroMRI is an MRI - based technology, no approvals and safety regulations of an ionizing irradiation, such as necessary for DXA or CT would apply.