COREDOCS INTERNATIONAL
A DIVISION OF SOLMEDEX, LLC
CoreDocs International is a premier provider of independent, unbiased imaging interpretations during the evaluation of pharmaceutical or medical device research studies. We utilize board certified experts in CT, MRI, angiography, ultrasound and x-ray, as well as clinical staff with extensive experience in all aspects of medical research, to help our clients with the following:
- Reduce inter-observer variability of imaging studies
- Provide an independent measurement of key trial data
- Increase the accuracy and precision of imaging interpretation results
- Provide standardized image acquisition training across all study sites
- Oversee compliance with imaging protocol guidelines
- Provide quality assurance of imaging studies and associated data
Processes and Standard Operating Procedures
- Utilize computer assisted quantitative analysis techniques
- Consistent use of analysis definitions, uniform technician training and variability testing
- Personnel are blinded to treatment regimen and device use
- Ability to receive and process imaging data in the following formats: film, Dicom and videotape
- All imaging data are screened to assure adequate image quality and imaging protocol compliance
- Physicians review all imaging data. A second physician, if necessary corroborates results
- Results are entered on worksheets specifically designed for each study and each imaging modality
Film Tracking and Compliance
- Customized film log databases track the receipt of imaging data and the status of each exam throughout the analysis process
Development of Analysis Definitions
- he Medical Director develops a customized set of analysis definitions for each exam type
- Collaborating physicians are trained on the analysis definitions and are familiar with the specific design of the clinical trial and the treatment
Database Programming
- Customized databases are developed and maintained allowing the sponser access via a web-based interface
- Ability to export databases to study sponsors for data analysis
Advanced Imaging Techniques
- CoreDocs International has extensive experience with advanced imaging techniques for CT, MRI and ultrasound
Additional Services
- Creation of SOPs and case report forms (CRF’s) for unique study designs
- Consultation on study design and image acquisition in order to maximize the power of the study and data capture
