Drug Trials
Imaging serves several roles in a drug trial. It can confirm eligibility, quantify disease burden and document response to treatment or the risks that accompany it. The value of that evidence rests on how well the endpoint is defined, how examinations are performed and whether assessments remain consistent from one participant, site and visit to the next.
Intrinsic Imaging provides core lab services for pharmaceutical and biotechnology trials from Phase I through Phase IV. Subspecialty physician interpretation, study-specific acquisition standards, central review and data management are planned together around the indication and the protocol’s evidence requirements, starting with the imaging charter and carrying through to final data delivery.
From the Clinical Question to the Imaging Assessment
Intrinsic Imaging works with sponsors to translate the protocol into an imaging charter that defines modalities, acquisition parameters, assessment criteria and review procedures. Site qualification and training establish how examinations should be performed, while centralized image collection and quality control address completeness and technical suitability before an examination advances to review.
Subspecialty physicians are selected for the indication, modality and assessment methodology, then qualified and trained for the study. Blinded independent central review, quantitative analysis and charter-defined adjudication preserve the intended read design. Imaging data reconciliation and controlled transfer connect the delivered results to the underlying assessments, giving sponsors a traceable record of the imaging endpoint.
Therapeutic Expertise and Imaging Methodology
The sources of imaging variability differ by disease, modality and endpoint. Intrinsic Imaging's therapeutic divisions bring clinical expertise to those distinctions, pairing indication-specific interpretation with the acquisition and review controls needed for longitudinal assessment. The following areas describe the principal imaging methods and clinical applications supported by each division.
Explore the therapeutic area overviewIntrinsic Imaging supports cardiovascular safety and efficacy assessments through central review of echocardiography, cardiac MRI, CT angiography and other cardiac imaging. Quantitative thoracic imaging, including high-resolution CT, extends that expertise to pulmonary and cardiopulmonary trials.
The division addresses functional, vascular and structural measures in indications such as heart failure, coronary disease and interstitial lung disease. Study-specific acquisition and measurement conventions support comparison across sites and longitudinal visits.
Intrinsic Imaging's neuroradiology expertise supports studies of neurodegenerative, inflammatory, cerebrovascular and other brain and spine disorders. Structural and functional MRI, CT, perfusion, diffusion and molecular imaging provide different approaches to assessing anatomy, lesion burden and disease-related biomarkers.
The review methodology is selected for the indication and the protocol, including trials in Alzheimer's disease, multiple sclerosis, Parkinson's disease and stroke. Consistent acquisition and interpretation are particularly important when the assessment depends on subtle changes over time.
Intrinsic Imaging combines gastrointestinal imaging and independent endoscopic review for studies evaluating disease activity and therapeutic response. CT, MRI, endoscopy and quantitative imaging support gastrointestinal, hepatobiliary and related abdominal indications.
The division also supports metabolic and renal endpoints, including DXA and MRI body-composition assessments in obesity studies and total kidney volume in polycystic kidney disease. Acquisition requirements and assessment methods are defined around the specific measure rather than a single approach to all abdominal imaging.
Intrinsic Imaging supports musculoskeletal trials with radiography, MRI, CT, quantitative CT and DXA, applying established and study-specific assessment methods. Imaging measures include joint-space width, cartilage thickness and volume, bone mineral density, inflammation and structural progression.
These methods support studies in osteoarthritis, rheumatoid arthritis, osteoporosis and other disorders of bone, joints, muscle and connective tissue. Standardized positioning, acquisition and scoring address the variability that can otherwise obscure small longitudinal changes.
Intrinsic Imaging provides blinded independent central review for oncology and immuno-oncology trials involving solid tumors and hematologic malignancies. Tumor assessments follow the protocol's specified response criteria, with expertise in RECIST 1.1, iRECIST, mRECIST, Lugano, Cheson and other indication-specific methods.
Reader training, longitudinal lesion assessment and adjudication are organized around the study's read design. Quantitative analysis and controlled imaging data delivery support the evaluation of safety and efficacy endpoints across phases of clinical development.
Intrinsic Imaging's ophthalmology specialists provide centralized review of retinal and ocular imaging, including optical coherence tomography, fundus photography and fluorescein angiography. These assessments support studies of retinal, macular and optic nerve disease, including diabetic retinopathy and age-related macular degeneration.
Ophthalmic programs can combine structural imaging with separately assessed visual function. Study-specific equipment qualification, acquisition requirements and reader preparation establish how each measure will be obtained and interpreted across visits.
Medical Device and AI/CAD Clinical Studies
Intrinsic Imaging also supports medical device and AI/CAD studies, which have distinct objectives and evidence requirements from drug trials. These programs draw on the same clinical specialties while using review designs appropriate to the medical device's intended use and the study's validation objectives.
Intrinsic Imaging provides independent imaging assessment for Class I, II and III medical device studies. Protocol-specific acquisition, central review and traceable imaging data support the evaluation of safety and performance and the preparation of imaging evidence for regulatory submissions.
Explore medical device studiesIntrinsic Imaging conducts clinical validation studies of AI and computer-aided detection or diagnosis software, including multi-reader multi-case designs. Study-specific case selection, reference standards and reader comparisons are developed around the software's intended clinical use and assessment objectives.
Explore AI/CAD clinical validation