Imaging Core Lab Services

WCG Intrinsic Imaging is a full-service medical imaging core lab providing comprehensive services to pharmaceutical, biotechnology and medical device companies in support of drug, medical device and artificial intelligence (AI) clinical trials.

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WCG Intrinsic Imaging Core Lab Services

WCG Intrinsic Imaging is a full-service medical imaging core lab providing comprehensive services to pharmaceutical, biotechnology and medical device companies in support of drug, medical device and artificial intelligence (AI) clinical trials.

We are also the world leader in conducting Artificial Intelligence (AI) / Computer Assisted Detection (CAD) clinical trials.

With our team of more than 500 board-certified and fellowship-trained physicians, WCG Intrinsic Imaging’s team has sub-specialization in all therapeutic areas, including, Oncology, Cardiology, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology.

500+ Board-Certified Fellowship Trained Physicians
5 ISO Quality Management System Certifications
Expertise in all therapeutic areas, indications and modalities

WCG Intrinsic Imaging: Imaging Core Lab Services in support of Clinical Trials

At WCG Intrinsic Imaging, we have the team, therapeutic expertise, technology and ISO certified quality management systems, to provide imaging core lab services to all pharmaceutical, biotechnology and medical device companies worldwide.

Imaging Core Lab Services

At WCG Intrinsic Imaging, we provide comprehensive medical imaging core lab services including overall leadership, study management, site management, imaging charter development, image acquisition protocol development and image transfer, case review and assessment and data management.

Study Management

At WCG Intrinsic Imaging, our teams specialize in providing imaging core lab services in support of Phase I-IV Clinical Trials and Class I, II and III Medical Device Trials.

Our Project Managers are experts in study management and have proven records of managing international clinical trials across all therapeutic areas and indications.

We manage all aspects of the imaging portion of the clinical trial and ensure to guide it towards success.

Site Management

At WCG Intrinsic Imaging, our teams specialize in managing international imaging sites participating in Phase I-IV Clinical Trials and Class I, II and III Medical Device Trials.

We currently support over 4,000 imaging sites in 75 countries, and we have extensive experience in qualifying and training imaging sites participating in clinical trials.

For each clinical trial, WCG Intrinsic Imaging manages all imaging sites and ensures that all sites are qualified, trained, and able to acquire and submit images as per the image acquisition protocol.

At WCG Intrinsic Imaging, we ensure quality. We monitor all sites throughout the entire trial and quality control each and every timepoint immediately upon receipt to ensure the best possible imaging throughout the entire clinical trial.

Imaging Charter

At WCG Intrinsic Imaging, our team of more than 500 board-certified and fellowship-trained physicians, are experts in all therapeutic areas.

Our team has expertise in Oncology, Cardiology, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology and their indications, allows us to develop a sophisticated and optimized Imaging Charter with the appropriate review criteria.

At WCG Intrinsic Imaging, we ensure all of our reviewers are experienced, appropriately trained and have the expertise needed to ensure quality assessments of even the most complex of indications.

Image Acquisition Protocol

At WCG Intrinsic Imaging, we recognize it is essential to ensure the correct acquisition of each patient’s imaging timepoint.

Our ISO certified processes ensure that the processing of patient images received from sites is meticulously planned, implemented and monitored for success.

Whether the images received are in support of a drug, medical device, or artificial intelligence (AI) clinical trial, our team has the expertise and experience to ensure quality and compliance of every patient scan.

Case Review

At WCG Intrinsic Imaging, our team consists of more 500 full time and consulting board-certified, fellowship-trained physicians and key opinion leaders (KOLs) with sub-specialization in all therapeutic areas.

Using our ISO certified process, we ensure to plan, implement and monitor case reviews meticulously to ensure success. All of our reviewers are experienced, appropriately trained and have the expertise needed to ensure quality assessments of even the most complex of indications.

Whether the review is in support of a Phase I-IV clinical trial or in support of a Class I, II or III trial to study a medical device, WCG Intrinsic Imaging physicians have the expertise and experience to provide comprehensive services to pharmaceutical, biotechnology and medical device companies worldwide.

Data Management

At WCG Intrinsic Imaging, our technology allows us to provide robust data management and accommodate even the most specialized clinical and medical device trials.

Our data management team ensures that the case report, database and data exports are designed and configured optimally to ensure the data is acquired, validated, stored, protected, and processed as expected to ensure the accessibility, reliability, and timeliness of the data.

In addition to having one of the most comprehensive and sophisticated quality management systems, and leading the industry with 5 ISO certifications, WCG Intrinsic Imaging’s data management team  also complies Good Automated Manufacturing Practice (GAMP®5).

Who We Serve

500+

Board-Certified Fellowship Trained Physicians

Pharmaceutical/Biotechnology

At WCG Intrinsic Imaging, our team consists of more than 500 board-certified, fellowship-trained physicians and key opinion leaders (KOLs) with sub-specialization in all therapeutic areas.

Our therapeutic expertise includes, but is not limited to:

Oncology
Cardiology
Central Nervous System
Gastroenterology
Musculoskeletal
Ophthalmology

ISO 13485 certified imaging core lab

Medical Device

WCG’s imaging team has extensive experience in providing imaging core lab services in support of Class I, II and III Medical Device Trials.

WCG Intrinsic Imaging is the only ISO 13485 certified imaging core lab specifically certified to provide quality imaging core lab services for Medical Device clinical trials. Intrinsic Imaging’s medical device certification was granted by the British Standards Institute (BSI), one of the world’s largest certification bodies.

Our fellowship trained physicians are responsible for a broad range of assessments and evaluations of medical devices across the range of therapeutic areas and are experts in protocol design and in the selection and the utilization of imaging modalities that are best oriented towards the placement, assessment and evaluation of various medical devices.

31+

AI trials supported worldwide

Artificial Intelligence Software (AI/CAD)

WCG Intrinsic Imaging is the world leader in conducting multi-case multi-reader studies to evaluate Artificial Intelligence (AI) and Computer Assisted Detection (CAD) systems.

We provide the most efficient means for Sponsors to conduct trials to assess the clinical performance of their AI/CAD software and obtain FDA clearance.

WCG Intrinsic Imaging is selected due to our:

• Extensive experience & expertise in large AI trials
• Multiple successful FDA Inspections with zero 483
• Proven success with multiple FDA medical device clearances
• ISO Certified quality management system
• ISO 13485 certification specifically for medical devices
• Certified by the British Standards Institute
• Routinely manage 6,000-20,000 case reviews

ISO Certified Quality Management System

ISO Certified Imaging Core Lab

WCG Intrinsic Imaging has one of the most comprehensive and sophisticated quality management systems in the industry:

  • Only imaging core lab in the world to hold 5 ISO quality management system certifications specifically for providing imaging core lab services on clinical trials.
  • Inspected by the FDA with Zero 483s.
  • Our quality management system is certified by the British Standards Institute (BSI).

Quality Management System

Unique in the industry, our quality management system is certified to ISO 9001, ISO 13485, ISO 22301, ISO 27001 and ISO 27018. Our certifications are specifically for providing imaging core lab services on clinical trials.

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

Contact WCG Intrinsic Imaging to discuss your trial’s imaging needs

At WCG Intrinsic Imaging, we have the team, therapeutic expertise, technology and ISO certified quality management systems, to provide imaging core lab services to our clients worldwide. Complete the form to get started.