WCG 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.
WCG Imaging is a full-service medical imaging core lab providing comprehensive services to pharmaceutical, biotechnology and medical device companies in support of drug and medical device clinical trials.
With our team of more than 600 board-certified and fellowship-trained physicians, WCG Imaging’s team has sub-specialization in all therapeutic areas, including, Oncology, Cardiology, Central Nervous System, Gastroenterology, Musculoskeletal and Ophthalmology.
Board-Certified Fellowship Trained Physicians
5 ISO Quality Management System Certifications
Expertise in all therapeutic areas, indications and modalities
At WCG 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.
At WCG 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 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 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.
At WCG Imaging, our team of more than 600 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 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 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.
At WCG Imaging, our team consists of more than 600 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 Imaging physicians have the expertise and experience to provide comprehensive services to pharmaceutical, biotechnology and medical device companies worldwide.
At WCG 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 Imaging’s data management team also complies Good Automated Manufacturing Practice (GAMP®5).
The WCG Imaging team has extensive experience in providing imaging core lab services in support of Class I, II and III Medical Device Trials.
WCG Imaging is the only ISO 13485 certified imaging core lab specifically certified to provide quality imaging core lab services for Medical Device clinical trials. WCG 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.
Artificial Intelligence Software (AI/CAD)
WCG 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 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
WCG 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.
Explore Our Therapeutic Expertise
Our Cardiothoracic Imaging Division has extensive experience in Cardiothoracic imaging in support of Phase I-IV Clinical Trials and Medical Device Trials.
Our cardiologists and radiologists are fellowship-trained to provide the highest level of expertise in the evaluation of thoracic and cardiovascular diseases.
Our cardiothoracic team are accomplished researchers and educators and several are internationally-recognized experts in cardiothoracic imaging serving in prominent roles within the Radiological Society of North America (RSNA), American Roentgen Ray Society (ARRS), Society of Thoracic Radiology (STR), Fleischner Society, American Board of Radiology (ABR), and American College of Radiology (ACR).
Cardiothoracic Imaging Expertise
Acute and Chronic Heart Failure
Acute Coronary Syndromes
Carotid Artery Disease
Congestive Heart Failure
Coronary Artery Calcium Scoring
Coronary Artery Disease
Deep Vein Thrombosis
Interstitial Lung Disease
Left Ventricular Dysfunction
Peripheral Vascular Disease
Pulmonary Arterial Hypertension
Sickle Cell Disease
Venous Thromboembolic Disease
Cardiothoracic Modality Expertise
CT, QCT, PET/CT
2D and 3D Echocardiography
MRA, MRI, MRE, Adenosine Stress MRI
Myocardial Strain imaging
Positron emission tomography (PET)
Thoracic Computed Tomography (CT)
Thoracic High Resolution CT (HRCT)
As an Imaging Core Lab, the WCG Imaging team has extensive experience in providing neuroradiology imaging services in support of Phase I-IV Clinical Trials and Medical Device Trials.
Our team of board-certified fellowship trained neuroradiologists specializes in all brain and spine pathology with broad experience and expertise in neuroradiology imaging using MRI, Volumetric MRI, CT, diagnostic and interventional angiographic procedures, as well as PET imaging using novel CNS markers.
Neuroradiology Imaging Expertise
Our neuroradiology team consists of board-certified, fellowship-trained neuroradiologists with expertise in the full spectrum of brain and spine disease processes.
Modality expertise including;
CT & CTA including CT perfusion
Diffusion tensor imaging
MRI & MRA including MR perfusion
Nuclear imaging including FDG PET
Ultrasound including transcranial doppler
Neuroradiology Imaging Indications
Aneurysm and vascular malformations
Parkinson’s including dyskinesia’s
Spinal degenerative diseases
Spinal cord injury
Traumatic Brain Injury
The WCG Imaging team has extensive experience in providing services in support of Phase I-IV Clinical Trials and Medical Device Trials involving gastrointestinal imaging.
Our board-certified gastroenterologists have an in depth understanding of the evaluation, prognosis, progression and treatment of GI related disorders. We also have further expertise and capabilities in interventional treatment techniques.
We are experts in the intervention of intestinal disorders including, but not limited to gastric, small bowel and colonic pathology, physiology and function.
We are able to guide the performance and radiographic interpretation of the entire digestive tract, including the pharynx, esophagus, stomach, duodenum, small intestine, colon and biliary system as well as all accessory organs to the alimentary canal.
Gastrointestinal Imaging Expertise
Our team of board-certified, fellowship-trained body and thorax radiologists review 500,000 body and thorax related images annually that encompass the full endocrine system.
Our radiologists are experienced in imaging of organ specific endocrine disorders as well as multiple endocrine syndromes and neoplasia.
Modality expertise including:
CT including novel techniques
High Resolution CT imaging and low dose techniques
Nuclear imaging with quantitative techniques
Expertise across all Indications
Inflammatory bowel disease
Irritable bowel syndrome (IBS)
Pelvic Inflammatory Disease
Short Bowel Syndrome
Ulcers – Gastric/Duodenal/H. Pylori
Diabetes and Diabetic sequelae
As an Imaging Core Lab, our team has extensive experience in providing services in support of Phase I-IV Clinical Trials and Medical Device Trials involving Musculoskeletal imaging.
Our expertise includes but is not limited to the full complement of joint and spine disease processes, musculoskeletal interventions including pain management and device.
Our multiple modality expertise in musculoskeletal imaging includes, but is not limited to, ultrasound, nuclear imaging, DXA, MR, and CT including novel techniques such as QCT, T2 Cartilage imaging, MARS imaging and kinetic MRI.
Expertise including but not limited to the full complement joint and spine disease processes
Expertise in Musculoskeletal imaging
Multiple modality expertise:
T2 Cartilage imaging
Chronic Lymphocytic Leukemia
CNS/Head and Neck
As an Imaging Core Lab, our team has extensive experience in providing services in support of Phase I-IV Clinical Trials and Medical Device Trials involving Cancer.
Oncology Imaging Expertise
The oncology team includes board-certified, fellowship-trained radiologists focused in oncology. The team’s expertise includes the full spectrum of oncology imaging and assessments for all indications.
Multiple Criteria expertise:
irRECIST & Immuno-Oncology
Multiple modality expertise:
CT including multi-slice
MRI including DCEMRI and Novel techniques,
PET/CT and Nuclear Imaging
Oncology Imaging Indications
Real time spinal motion
Real time spinal kinetics
Spinal muscular atrophy
Our team has experience in providing services in support of Phase I-IV ophthalmology clinical trials.
Our team consists of board-certified ophthalmologists and our expertise includes the full spectrum of ophthalmology imaging and assessments.
Contact WCG Imaging to discuss your trial’s imaging needs
At WCG 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.