Medical Imaging Process
RadPharm offers a proven, validated imaging process – from study start up and charter development to site qualification/ initiation and image management to post submission data archiving. When you partner with RadPharm, you are assured the medical imaging portion of your clinical trial is managed by medical and scientific experts, utilizing advanced technology.
From project onset, our experienced project team works with you to develop and implement a streamlined process based on your study protocol, driven by a comprehensive communication plan. Stringent quality and security standards are applied, guaranteeing GCP, ICH and 21 CFR part 11 compliance.
RadPharm offers the flexibility to meet your aggressive timelines and deliverables in a quality environment.
Study Start up, Site Initiation and Support
 RadPharm’s commitment to delivering the highest quality service is assured long before an image arrives at our door. 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 in combination with a study specific communication, data management and quality assurance plan.
- Assist with protocol development
- Develop Image Review Charter
- Provide study manuals and documentation
- Attend Investigator meetings and training
- Qualify sites
- Initiate / re-initiate sites
- Provide training, supplies and 24/7 technical support
- Site manual
Image Acquisition and Tracking
- Collect digital media via secure internet transfer system
- Digitize images
- DICOM image conversion
- Perform de-identification of image data
- Image Quality Assessment (IQA)
- Archive actively and post study
- Real-time project reporting via a secure 24/7 Sponsor eRoom web portal with customized reports
Image Quality Assessment (IQA)
Every image we receive is blinded, appropriately labeled and logged into our robust Work Flow Management System. An Image Quality Assessment
(IQA) is performed for protocol compliance and interpretability. The image is
stored in our digital image repository en-route to image interpretation.
RadPharm has developed a proven process. From protocol design through regulatory submission, each facet of our imaging process is handled in a stringent, quality controlled environment.
Independent Review
 RadPharm strongly believes that only board-certified physicians should be responsible for the interpretation of radiographic images. Our on-site staff of radiologists and oncologists are experienced in the rigors of clinical trial conduct. We will select a team of sub-specialty trained, board-certified radiologists and train them in all aspects of a protocol. Each radiologist is arbitrarily assigned a set of subjects for image interpretation and the same radiologist will read all time points for an individual subject from baseline until completion.
Data Management
 Oracle Clinical 4.5.1 (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
- 21 CFR part 11 compliant
Image Storing & Archiving
- Concordant with Agency requirements
- GCP, ICH and CFR 21 guideline compliant
- Comprehensive digital audit trail
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