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Medical Image Process
CoreLab Partners offers a proven, validated imaging process that includes: study start-up, charter development, site qualification/initiation, image management, and post submission data archiving. When you partner with CoreLab Partners, you are assured that medical and scientific experts, utilizing advanced technology, will manage the medical imaging aspect of your clinical trial.
Our experienced project team works with you to develop and implement a streamlined process based on your study protocol. We adhere to quality and security standards that guarantee compliance with GCP, ICH, and 21 CFR part 11. We also offer the professionalism, dedication, and flexibility to meet your aggressive timelines and deliverables in a rigorous, quality-controlled environment.
Study Start-up, Site Initiation, and Support
CoreLab Partners’ commitment to delivering the highest quality service is assured long before we receive your study images. To start, an experienced team of imaging experts, including a board-certified radiologist, performs a systematic technological and medical review of the study protocol. The team develops and defines standards in an independent review charter along with a study specific communication, data management, and quality assurance plan.
- Assist with protocol development
- Develop independent review charter
- Provide study manuals and documentation
- Attend Investigator meetings and training
- Qualify sites
- Initiate and/or re-initiate sites
- Provide training, supplies, and 24/7 technical support
- Develop site manual
Image Acquisition and Tracking
- Collect digital media via secure Internet transfer platform
- Digitize images
- Perform de-identification of image data
- Provide image quality assessment
- Archive during and post study
- Deliver real-time project reports via a secure 24/7 web portal
Image Quality Assessment
Every image we receive is blinded, labeled, and logged into our robust Work Flow Management system. An image quality assessment is performed for protocol compliance and interpretability. The image is then stored in our digital image repository en route to image interpretation.
Independent Review
Because the endpoints of your study may depend on the correct interpretation of medical images, CoreLab Partners employs only board-certified physicians expertly qualified in radiographic image interpretation and the conduct of clinical trials. To reduce variability, each radiologist is assigned to a blinded set of subjects and interprets all images at all time points for an individual subject from baseline until completion.
Data Management and Image Archiving
- Oracle Clinical 4.6 (OC) database platform
- Direct e-transfer to OC database
- Data export in sponsor-specified format
- Database design and setup
- Robust edit checks and derivation procedures
- GCP, ICH, and 21 CFR part 11 compliant
Discover why so many sponsors depend on the imaging expertise of CoreLab Partners - contact us today!
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