Why Imaging Core Lab and Imaging CRO come to existence

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