Here is a table comparing side-by-side the “clinical trial imaging” with the routine “clinical service imaging” practiced every day at hospitals. This shows why a new service sector is needed in addition to the current stakeholders of drug development (among them are sponsor, CRO, investigator and regulatory authority) aiming at bridging up all the parties and communicating among all from imaging aspects, namely imaging core lab or imaging CRO.
Clinical Trial Imaging | Clinical Service Imaging Practiced at Hospitals | |
Source of Practice | Pharmaceutical Company and CRO – the Biotech Sector | Hospital and Insurance Provider – the HealthCare Sector |
Territory/Venue | Global | Local/Regional |
Timeliness | Not as Urgent | Urgent |
Reading Mode | Strictly Blinded Read | Open Informed Read |
Imaging Protocol | Standardized Acquisition and Contrast Injection Protocol | Flexible Acquisition and Contrast Injection Protocol |
FDA Requirement | 21 CFR-Part 11 | 501(k) Clearance |
Regulation | Highly Regulated | Regulated |
Post-Processing Software | Trial by Trial, Pay per Click Preferred | Closely Associated with Scanner and Vendor |
IT Interfacing | Clinical Trial Management System/Database | PACS/RIS/HIS |
Trial Centered | Patient Centered |
Contact us for more information about our Imaging Core Lab service: info@twan-biotech.com