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Every Guidance for Sponsors article, case study and press release from Intrinsic Imaging is available here as a PDF. Use the filters to narrow by type and therapeutic area. Nothing is behind a form.
183 downloads
Case study
Pivotal MRMC Study of CAD Software With 14,400 Reviews With and Without CAD
AI/CAD
Case study
Tenth MRMC Trial for CAD, AI and Deep Learning Software
AI/CAD
Case study
Pivotal MRMC Trial of AI Software Detecting Musculoskeletal Pathology
AI/CAD
Case study
Pivotal Device Trial of AI Software for Screening Clinical Images
AI/CAD
Case study
Pivotal MRMC Trial of AI Detection Software With 14,000 Radiology Reviews
AI/CAD
Case study
Five-Year Multicenter Metastatic Colorectal Cancer Trial Across 40 Sites
Oncology
Case study
Four-Year Multinational Phase II Metastatic Breast Cancer Trial Across 60 Sites
Oncology
Case study
Breast Cancer Trial With 3,000 Multimodality Breast Imaging Reviews
Oncology
Case study
Phase II Metastatic Pancreatic Cancer Trial With RECIST and PERCIST
Oncology
Case study
Phase I/II Biologic Trial in Metastatic Colorectal Cancer With Unresectable Liver Metastases
Oncology
Case study
Global Hepatocellular Carcinoma Trial With Dynamic Contrast-Enhanced MRI
Oncology
Case study
International Phase II Non-Hodgkin Lymphoma Trial With PET/CT and PET/MRI
Oncology
Case study
International Phase II Trial in Advanced Squamous Cell Carcinoma
Oncology
Case study
Phase II Glioblastoma Multiforme Trial With Central Neuroradiology Review
Oncology
Case study
Pivotal Phase III Comparison of an Oral Chemotherapeutic Against the Leading Metastatic Breast Cancer Therapy
Oncology
Case study
International Phase III Trial of a Novel Approach to NSCLC Brain Metastases
Oncology
Case study
Global Phase III Oral Chemotherapeutic Trial in Metastatic Breast Cancer
Oncology
Case study
Phase II Immuno-Oncology Trial in NSCLC and SCLC
Oncology
Case study
Phase III NSCLC Brain Metastases Trial With 6,000 Neuroradiology Assessments
Oncology
Case study
GIST Trial With RECIST 1.1 and Choi Criteria
Oncology
Case study
Neurointerventional Endovascular Device Trial
Medical Device
Case study
International Phase III Orthopedic Device Trial With 7,000 Imaging Examinations
Medical Device
Case study
Multi-Center Study of a Novel Vascular Device
Medical Device
Case study
Clinical Study of a Novel Neurointerventional Device
Medical Device
Case study
Four-Year Venous Stent Trial for Symptomatic Venous Outflow Obstruction
Medical Device
Case study
International Trial of a Medical Device for the Treatment of Lung Cancer
Medical Device
Case study
Genitourinary Device Trial With Dynamic Pelvic Floor MRI
Medical Device
Case study
International Phase II Study of a Novel Vascular Device
Medical Device
Case study
Interventional Device Trial for Prevention of Pulmonary Emboli
Medical Device
Case study
Interventional Device Trial for Percutaneous Tumor Ablation
Medical Device
Case study
International Class III Device Trial for Lower Back Pain
Medical Device
Case study
Validation Study of a Gastrointestinal Motility Device With a Radiation-Sparing Protocol
Medical Device
Case study
Phase II Evaluation of a Novel Tumor Imaging Platform
Medical Device
Case study
Cardiovascular Clinical Trial With 1,500 Multimodality Reviews
Cardiovascular & Thoracic
Case study
International Phase III Cystic Fibrosis Trial With Structured Chest CT Scoring
Cardiovascular & Thoracic
Case study
International Phase II Cardiac Safety Trial With Cardiac MRI
Cardiovascular & Thoracic
Case study
Pivotal Multi-Center Acute Ischemic Stroke Trial
Central Nervous System
Case study
International Phase III Severe Traumatic Brain Injury Trial Across 100+ Sites
Central Nervous System
Case study
Five-Year International Phase II Iron Overload Trial With 4,500 MRI Scans
Gastroenterology & Metabolic
Case study
Three-Year International Phase II Trial in Chronic Iron Overload
Gastroenterology & Metabolic
Case study
Global Phase II Arthritis Trial With Quantitative Joint Imaging
Musculoskeletal
Case study
Pivotal Phase II Biologic Trial in a Rare Degenerative Neuromuscular Disorder
Musculoskeletal
Case study
Obesity Trial With DXA Body Composition and MRI Fat Quantification
Gastroenterology & Metabolic
Case study
Imaging Core Lab Support Through NDA Submission and FDA Inspection
Oncology
Case study
Multiple Myeloma Trial With IMWG Imaging Criteria
Oncology
Case study
ARIA Safety Monitoring in an Anti-Amyloid Alzheimer's Trial
Central Nervous System
Case study
Radioligand Therapy Trial With PSMA PET Eligibility and Dosimetry
Oncology
Case study
Idiopathic Pulmonary Fibrosis Trial With Quantitative HRCT
Cardiovascular & Thoracic
Case study
Phase I/IIa Imaging Endpoint Strategy for a Biotech Go/No-Go Decision
Oncology
Case study
Imaging Data Transfer and Query Resolution Integrated With Sponsor EDC
Cardiovascular & Thoracic
Case study
Rare Disease Cardiomyopathy Trial With Echo and Cardiac MRI
Cardiovascular & Thoracic
Case study
ADPKD Trial With Total Kidney Volume MRI
Gastroenterology & Metabolic
Case study
Cervical Disc Replacement IDE Trial With Range-of-Motion Analysis
Medical Device
Guidance for Sponsors
Quantitative Neuroimaging of Alzheimer's Disease
Central Nervous System
Guidance for Sponsors
Traumatic Brain Injury: Medical Imaging in Clinical Trials
Central Nervous System
Guidance for Sponsors
Imaging and Monitoring Tumor Response in Clinical Trials
Oncology
Guidance for Sponsors
Complex Spinal Deformities: Medical Imaging in Clinical Trials
Musculoskeletal
Guidance for Sponsors
Advances in Imaging of Rheumatoid Arthritis
Musculoskeletal
Guidance for Sponsors
Tissue Iron Deposition: MRI Quantitation in Clinical Trials
Cardiovascular & Thoracic
Guidance for Sponsors
Neurological Imaging: Contrast Enhancement in Clinical Trials
Central Nervous System
Guidance for Sponsors
Metastatic Colorectal Cancer and Locoregional Therapies
Oncology
Guidance for Sponsors
WHO, RECIST, EASL, mRECIST and Cheson: Challenges of Evaluating Tumor Response
Oncology
Guidance for Sponsors
Inferior Vena Cava Filters: Medical Imaging in Clinical Trials
Cardiovascular & Thoracic
Guidance for Sponsors
Immunotherapy and Imaging of Metastatic Pancreatic Adenocarcinoma
Oncology
Guidance for Sponsors
Advances in Imaging of Non-Small Cell Lung Cancer (NSCLC)
Oncology
Guidance for Sponsors
Functional Imaging of the Dopamine Pathway
Central Nervous System
Guidance for Sponsors
Temporal Lobe Epilepsy and Volumetric MRI in Clinical Trials
Central Nervous System
Guidance for Sponsors
irRECIST and Immuno-Oncology in Clinical Trials
Oncology
Guidance for Sponsors
Contrast Echocardiographic Imaging in Clinical Trials
Cardiovascular & Thoracic
Guidance for Sponsors
Coronary Artery Calcium Scoring in Clinical Trials
Cardiovascular & Thoracic
Guidance for Sponsors
The Challenge of Quantitative Measurements of Primary Brain Tumors in Clinical Trials
Central Nervous System
Guidance for Sponsors
Medical Imaging of Osteoarthritis of the Knee in Clinical Trials
Musculoskeletal
Guidance for Sponsors
Medical Imaging of Chronic Lymphocytic Leukemia
Oncology
Guidance for Sponsors
Quantitative MRI Imaging in Orthopedic Clinical Trials
Musculoskeletal
Guidance for Sponsors
Magnetic Resonance Elastography: A Quantitative Endpoint for Liver Fibrosis Trials
Gastroenterology & Metabolic
Guidance for Sponsors
Screening Mammography AI: A Continued Market Opportunity
AI/CAD
Guidance for Sponsors
Oncologic Imaging: The Benefits of Diffusion-Weighted MRI
Oncology
Guidance for Sponsors
Imaging Analysis and Operative Treatment of Diaphyseal Fractures
Musculoskeletal
Guidance for Sponsors
Orthopedic Device Assessments: Medical Imaging Challenges in Clinical Trials
Musculoskeletal
Guidance for Sponsors
The Challenges of Reducing Lung Cancer Mortality with Screening
Oncology
Guidance for Sponsors
Computed Tomography Data Acquisition in Clinical Trials
Oncology
Guidance for Sponsors
Advances in High-Field MRI for the Assessment of Arthritis
Musculoskeletal
Guidance for Sponsors
Muscular Dystrophy: Medical Imaging in Clinical Trials
Musculoskeletal
Guidance for Sponsors
Echocardiography: Advantages in Clinical Trials
Cardiovascular & Thoracic
Guidance for Sponsors
Osteoporosis Therapy: Challenges in Monitoring Efficacy in Clinical Trials
Musculoskeletal
Press release
Intrinsic Imaging Announces Acquisition, Accelerating Global Expansion as a Leading Imaging Core Lab
Press release
Intrinsic Imaging Core Lab Announces its Acquisition for $80 Million
Press release
Intrinsic Imaging Undergoes Third FDA Inspection with No 483 Observations
Press release
Intrinsic Imaging Undergoes Extensive FDA BIMO Inspection — Receives Zero 483 Observations
Press release
Intrinsic Imaging Publishes Results of Artificial Intelligence (AI) Pivotal Study in the American Journal of Roentgenology
Press release
ISO Certified Intrinsic Imaging Core Lab Completes Very Large 12,480 Read Pivotal Oncology Clinical Trial in 5 Weeks
Press release
Leading Artificial Intelligence Company Selects Intrinsic Imaging to Conduct Pivotal Clinical Trial to Support FDA Submission
AI/CAD
Press release
Intrinsic Imaging Selected by an Emerging Artificial Intelligence (AI) Company for Pivotal Medical Device Clinical Trial
AI/CAD
Press release
Intrinsic Imaging Selected by Emerging AI Company for Pivotal Medical Device Clinical Trial
AI/CAD
Press release
Intrinsic Imaging Awarded Pivotal Phase II Clinical Trial Focused on Treatment of Degenerative Neuromuscular Disorder
Musculoskeletal
Press release
Intrinsic Imaging Awarded Its Tenth Clinical Trial for Computer Aided Detection (CAD) / Artificial Intelligence (AI) / Deep Learning (DL) Software
AI/CAD
Press release
Intrinsic Imaging Awarded New Clinical Study to Evaluate Innovative Tumor Imaging Platform
Medical Device
Press release
Intrinsic Imaging Awarded a Validation Study for the Development of an Innovative Medical Device to Aid in the Evaluation of Gastrointestinal Motility
Medical Device
Press release
Intrinsic Imaging Awarded Another Pivotal Multiple-Reader Multiple-Case (MRMC) Study to Assess the Clinical Performance of CAD Software
AI/CAD
Press release
Intrinsic Imaging Awarded GIST Clinical Trial for the Treatment of Gastrointestinal Stromal Tumors
Oncology
Press release
Intrinsic Imaging Awarded Phase III Clinical Trial Focused on Brain Metastases of Non-Small Cell Lung Cancer (NSCLC)
Oncology
Press release
Intrinsic Imaging Awarded Phase II Immuno-Oncology Clinical Trial for the Treatment of Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Oncology
Press release
Intrinsic Imaging's Quality Management System Attains ISO 27001 Informational Security Certification
Press release
Intrinsic Imaging Awarded International Clinical Trial to Determine Efficacy of Innovative Class III Medical Device
Medical Device
Press release
Intrinsic Imaging Awarded Large Pivotal Phase III Oncology Trial for Metastatic Breast Cancer
Oncology
Press release
Intrinsic Imaging Awarded International Phase III Trial for Novel Treatment of Non-Small Cell Lung Cancer Brain Metastases
Oncology
Press release
Intrinsic Imaging at ASCO 2016
Press release
Intrinsic Imaging Sponsors Webinar: Medical Imaging — The Advantages of an ISO Certified Quality Management System
Press release
Intrinsic Imaging Awarded International Phase II Trial for Arthritis
Musculoskeletal
Press release
Clinical Trial Sponsors Agree Intrinsic Imaging Core Lab Provides Exceptional Quality
Press release
Todd Joron, Intrinsic Imaging's President and COO, to Speak at Imaging in Clinical Trials, March 29–30 in Philadelphia
Press release
Intrinsic Imaging's ISO Certified Quality Management System to be Featured at the Imaging in Clinical Trials Event
Press release
Intrinsic Imaging Awarded Pivotal Phase III Trial to Assess Novel Oral Chemotherapeutic for Metastatic Breast Cancer
Oncology
Press release
Intrinsic Imaging Awarded Medical Device Trial for Percutaneous Tumor Ablation
Medical Device
Press release
Intrinsic Imaging Awarded Phase II Clinical Trial for Glioblastoma Multiforme
Oncology
Press release
Intrinsic Imaging Awarded Phase II Clinical Trial for Advanced Squamous Cell Carcinoma
Oncology
Press release
Intrinsic Imaging Awarded Interventional Medical Device Trial for Prevention of Pulmonary Emboli
Medical Device
Press release
Intrinsic Imaging Reports Exceptional 2014 Customer Satisfaction Survey Results
Press release
Intrinsic Imaging Expands Its Medical Imaging Consulting Group for Clinical Trials
Press release
Intrinsic Imaging Awarded Phase II Clinical Trial to Assess New Treatment for Non-Hodgkins Lymphoma
Oncology
Press release
Intrinsic Imaging Awarded International Phase II Study for Novel Vascular Medical Device
Medical Device
Press release
Intrinsic Imaging Awarded Genitourinary Medical Device Clinical Trial
Medical Device
Press release
Intrinsic Imaging ISO 13485 Medical Device Certification Leads to Award of Lung Cancer Clinical Trial
Medical Device
Press release
Intrinsic Imaging Awarded Landmark Medical Device Trial for Treatment of Symptomatic Venous Outflow Obstruction
Medical Device
Press release
Intrinsic Imaging Awarded Global Clinical Trial for Hepatocellular Carcinomas
Oncology
Press release
Intrinsic Imaging Obtains ISO 22301:2012 Business Continuity Management System Certification
Press release
Intrinsic Imaging Awarded Clinical Study for Novel Neurointerventional Medical Device
Medical Device
Press release
Intrinsic Imaging Obtains ISO 13485 Medical Device Certification
Press release
Intrinsic Imaging Undergoes Extensive Quality Audit — Receives Zero Observations
Press release
Intrinsic Imaging Core Lab Expertise Contributes to Another FDA Approval
Press release
Intrinsic Imaging Awarded Phase II Clinical Trial for Cardiovascular Disease
Cardiovascular & Thoracic
Press release
Intrinsic Imaging Awarded Multi-Center Study for a Novel Vascular Medical Device
Medical Device
Press release
Intrinsic Imaging Awarded International Phase II Clinical Trial for Chronic Iron Overload
Gastroenterology & Metabolic
Press release
Metastatic Colorectal Cancer (mCRC) Phase I/II Trial Awarded to Intrinsic Imaging
Oncology
Press release
Intrinsic Imaging Awarded Large 5 Year International Phase II Clinical Trial to Treat Iron Overload
Gastroenterology & Metabolic
Press release
Intrinsic Imaging Opens Medical Imaging Office in Greater Boston
Press release
BSI Awards ISO 13485:2003 Quality Certification to Intrinsic Imaging
Press release
Orthopedic Medical Device Phase III Clinical Trial Awarded to Intrinsic Imaging
Medical Device
Press release
Intrinsic Imaging Awarded Large International Phase III Clinical Trial for the Treatment of Severe Traumatic Brain Injury
Central Nervous System
Press release
Intrinsic Imaging Undergoes Extensive FDA Audit – Receives Zero 483 Observations
Press release
Intrinsic Imaging Awarded International Phase III Clinical Trial for Cystic Fibrosis
Cardiovascular & Thoracic
Press release
Intrinsic Imaging Awarded Phase II Trial for Metastatic Pancreatic Cancer
Oncology
Press release
Intrinsic Imaging Core Lab Expertise Contributes to FDA Clearance of Medical Device
Press release
Intrinsic Imaging Implements ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Press release
Intrinsic Imaging Awarded Cardiovascular Clinical Trial
Cardiovascular & Thoracic
Press release
Intrinsic Imaging Awarded Important Clinical Trial for the Evaluation of Breast Disease
Oncology
Press release
Intrinsic Imaging Obtains ISO 9001:2008 Quality Certification by World Leading Certification Body
Press release
Neurointerventional Medical Device Clinical Trial Awarded to Intrinsic Imaging
Medical Device
Press release
Intrinsic Imaging Awarded Multinational Phase II Trial for the Study of Metastatic Breast Cancer
Oncology
Press release
Intrinsic Imaging Joins Metastatic Colorectal Cancer Trial
Oncology
Press release
Intrinsic Imaging Awarded Pivotal Multi-Center Clinical Trial for Acute Ischemic Stroke
Central Nervous System
Press release
Omnicare to Employ Merge Clinical Trial Imaging Application — Featuring Intrinsic Imaging
Press release
Intrinsic Imaging's Quality Management System Attains ISO 9001:2008 Compliance
Press release
Intrinsic Imaging Establishes Global Imaging Center Consortium for Multi-Center Clinical Trials
Press release
Intrinsic Imaging Appoints Leading Vascular and Interventional Radiologist Dr. Amit Mehta as Vice President and Chief Medical Officer
Press release
Intrinsic Imaging Publishes Its Metrics Champion Consortium Imaging Performance Targets
Press release
Intrinsic Imaging and Merge Healthcare Announce Technology Agreement
Press release
Announcing Intrinsic Imaging – Radiology Experts Launch Novel Medical Imaging Core Lab for Clinical Trials
Case study
Rescuing a Global Phase III Solid Tumor Trial
Oncology
Case study
Phase III Immunotherapy RECIST and iRECIST
Oncology
Case study
MRMC Reader Study for AI 510(k) Submission
AI/CAD
Case study
Phase II Alzheimer's Amyloid PET and MRI
Central Nervous System
Case study
IDE Pivotal Transcatheter Valve Trial
Medical Device
Case study
Global Cardiovascular Trial With CCTA and MRI
Cardiovascular & Thoracic
Case study
Phase III Knee Osteoarthritis DMOAD Trial
Musculoskeletal
Case study
Phase IIb Inflammatory Bowel Disease Trial
Gastroenterology & Metabolic
Case study
Geographic Atrophy and Neovascular AMD Trial
Ophthalmology
Case study
Fast-Track Rare Disease Oncology Trial
Oncology
Case study
Mid-Study Transfer of a Phase III MS MRI
Central Nervous System
Case study
Rescuing a Stalled Peripheral Vascular Trial
Medical Device
Case study
Lymphoma Trial Using Lugano Classification
Oncology
Case study
Glioblastoma Trial With RANO Criteria
Oncology
Case study
Metastatic Prostate Cancer With PCWG3 Review
Oncology
Case study
Hepatocellular Carcinoma Trial Using mRECIST
Oncology
Case study
Ground Truth for a Breast Cancer Detection AI
AI/CAD
Case study
Chest CT Lung Nodule MRMC Reader Study
AI/CAD
Case study
Spinal Fusion Device Trial With Fusion Review
Medical Device
Case study
Parkinson's Trial With DaT-SPECT Imaging
Central Nervous System
Case study
Heart Failure Trial Echocardiography Core Lab
Cardiovascular & Thoracic
Case study
Rheumatoid Arthritis Modified Sharp Scoring
Musculoskeletal
Case study
NASH Trial With MRI-PDFF and Liver Stiffness
Gastroenterology & Metabolic
Case study
Diabetic Macular Edema Trial OCT Endpoints
Ophthalmology
Case study
Rapid Pediatric Neuroblastoma Trial Startup
Oncology