RadPharm offers a proven, completely validated imaging process – from study start up and charter development to site and image management to post submission data archiving. When you partner with RadPharm, you can be confident that the medical imaging portion of your clinical trial is wholly GCP, ICH and 21 CFR compliant.
From project onset, our experienced project team works with you to develop and implement a streamlined process based on your study protocol and grounded in open communication. Our imaging process is performed in a stringent QC environment and includes:
Study initiation and start-up
- Charter development
- Protocol review
- Study manuals and documentation
- Investigator meeting attendance and training
Site initiation and management
- Site qualification
- Initiation / re-initiation
- Site visit(s)
- Technical support, training and supplies
Image acquisition and management
- Site management
- Digital image acquisition
- Internet media transfer
- Digitization of film, if necessary
- DICOM image conversion
- De-identification
- Image quality assessment
- Active and post-study storage
Data management
- Ubiquitous Oracle Clinical platform
- 21 CFR Part 11 compliance
- Database design and setup
- Data entry, review and resolution
- Data exports
Shorten your timelines and save associated costs by employing an efficient, proven process only RadPharm can deliver. Call us today to discuss at 609-936-2600 or contact us. |
