Imaging Core Lab for Clinical Trials

ISO Certified Medical Imaging Core Lab Services
for Phase I-IV Clinical Trials and Class I,II, III Medical Device Trials

Overview

Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001, ISO 13485 and ISO 22301 certified and GAMP® 5 compliant medical imaging core lab.

As a full-service medical imaging core lab, we provide comprehensive services is support of Phase I-IV Clinical Trials and Class I,II, III Medical Device Trials.

More specifically we provide comprehensive medical imaging core lab services including overall leadership, project management, imaging charter development, image acquisition protocols, imaging site qualification training and management, patient scan transfer and quality control. We also provide complete image review by our 70 full time board-certified fellowship trained radiologists.

At Intrinsic, we have the team, the technology and the therapeutic expertise to manage your entire medical imaging trial. Our team of board-certified radiologists have decades of experience in all therapeutic areas and all imaging modalities.

Imaging Core Lab Services

  • Study Management
  • Imaging Charter Development
  • Image Acquision Protocol
  • Imaging Site Qualification
  • Imaging Site Training
  • Patient Scan Acquisition
  • Patient Scan Processing
  • Patient Scan Quality Control
  • Query Management
  • Radiologist Review
  • Data Management
Intrinsic imaging is ISO 9001 / 13485 / 22301 Certified
iso_square

ISO Certified Medical Imaging Core Lab

While all companies state they are committed to quality, only Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the industry.

Our quality management system is FDA audited, ISO 9001, ISO 13485 and ISO 22301 certified and GAMP® 5 compliant.

Most noteworthy to our Sponsors, Intrinsic Imaging ISO certified quality management systems enables us to conduct trials with unmatched operational excellence to ensure on time quality results.

ISO Certified Quality Management System

Our FDA audited, ISO 9001, ISO 13485 and ISO 22301 certified and GAMP 5 compliant quality management systems are testaments of our ongoing commitment to providing quality medical imaging core lab services.

In addition to our team, technology and therapeutic expertise, our ISO certified quality management system also provides Sponsors with high confidence in Intrinsic Imaging’s abilities as a leading medical imaging core lab.

Intrinsic Imaging Core Lab Services by the Numbers

0
Full time Board Certified Fellowship Trained Radiologists
0
Imaging Sites
0
ISO Certifications
0
Patient Timepoints Reviewed Annually