Why Imaging Core Lab and Imaging CRO come to existence

//Why Imaging Core Lab and Imaging CRO come to existence
Why Imaging Core Lab and Imaging CRO come to existence2014-05-14T10:50:45+08:00

clinical-imaging

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 ImagingClinical Service Imaging Practiced at Hospitals
Source of PracticePharmaceutical Company and CRO – the Biotech SectorHospital and Insurance Provider – the HealthCare Sector
Territory/VenueGlobalLocal/Regional
TimelinessNot as UrgentUrgent
Reading ModeStrictly Blinded ReadOpen Informed Read
Imaging ProtocolStandardized Acquisition and Contrast Injection ProtocolFlexible Acquisition and Contrast Injection Protocol
FDA Requirement21 CFR-Part 11501(k) Clearance
RegulationHighly RegulatedRegulated
Post-Processing SoftwareTrial by Trial, Pay per Click PreferredClosely Associated with Scanner and Vendor
IT InterfacingClinical Trial Management System/DatabasePACS/RIS/HIS
Trial CenteredPatient Centered

Contact us for more information about our Imaging Core Lab service: info@twan-biotech.com