Oncology
Oncology Imaging Expertise
We are the global leaders in providing imaging services for Oncology clinical trials. Our experience includes Phase I-IV trials in Oncology, including registration studies in both the U.S. and Europe.
Experience Across Oncology Indications
- Acute Lymphocytic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Bladder Cancer
- Brain Cancer
- Breast Cancer
- Chronic Lymphocytic Leukemia (CLL)
- Colon Cancer
- Colorectal Cancer (CRC)
- Cutaneous T-cell Lymphoma
- Endometrial Cancer
- Gastric Cancer
- Glioblastoma
- Head and Neck Cancer
- Hepatocellular Carcinoma
- Hodgkin’s Lymphoma
- irRC and Disease Recurrence Criteria
- Interstitial Lung Disease
- Leukemia
- Liver Cancer
- Lymphoma
- Melanoma
- Multiple Myeloma
- Non-Hodgkin’s Lymphoma (NHL)
- Non-Small Cell Lung Cancer (NSCLC)
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Renal Cell Carcinoma (RCC)
- Resected Solitary Bone Metastasis
- Sarcomas
- Small Cell Lung Cancer (SCLC)
- Solid Tumor
- Squamous Cell Carcinoma
- Thyroid Cancer
- Urothelial Cancer
Read Team
Our dedicated team of radiologists, oncologists, technicians, regulatory experts, and project managers is among the most knowledgeable and well-respected in the industry. Our services also include safety monitoring. experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.Reader Training
Through a combination of our expert radiologists and our rigorous training and testing regimen, we are committed to increasing the accuracy and precision of data subject to blinded independent central review. Sponsors have the flexibility of working with our highly-trained in-house radiologists, with subspecialty-trained board-certified radiologists from the Harvard Hospital System, or with other radiologists of the sponsor’s choice.
Evaluation Criteria Expertise
- Cheson 1999, 2007
- DWI-MRI
- FDG-PET quantitative and semi-quantitative assessments
- Immune-related response criteria (irRC)
- iRECIST
- irRECIST
- IWG
- Lugano Classification
- Macdonald
- mRecist
- PCWG2/PCWG3
- Percist
- PET SUV, PET-CT
- Quantitative Metabolic Rates
- RANO
- RECIST 1.0, RECIST 1.1
- Tumor volume
- WHO
Study Design
Our experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.
Web-Based Technology Platform
Our state-of-the-art systems are 21 CRF Part 11 compliant and are used to analyze images from all modalities. The systems can be accessed by radiologists to perform assessments anywhere in the world. Thousands of clinical sites in the U.S., Latin America, Europe, and Asia-Pacific have uploaded imaging data directly into our secure system.
Regulatory Experience
We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division and the European Medicines Agency (EMA). Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards.