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.
Our team has provided imaging CRO services
on more than 200 Oncology clinical trials across indications including:
- Cutaneous T-cell Lymphoma
- Hepatocellular Carcinoma
- Non-Hodgkin's Lymphoma
- Multiple Myeloma
- Non-small cell lung carcinoma
- Renal Cell Carcinoma
- Resected solitary bone metastasis
- Solid tumor
- Squamous Cell Carcinoma
Evaluation criteriaWe have extensive experience with studies involving the following types of evaluation criteria: - RECIST 1.0, RECIST 1.1 - Cheson 1999, 2007 - RANO - Macdonald - DWI-MRI - Tumor volume - PET SUV, PET-CT - Immune-related response criteria (irRC) - Lugano classification
- FDG-PET quantitative and semi-quantitative assessments
- Quantitative Metabolic Rates
Examples of Oncology Studies
In the table below are examples of the types of Oncology studies we have performed:
Read TeamOur 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.
Study designOur 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 trainingThrough 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 sub-specialty-trained board-certified radiologists from the Harvard Hospital System, or with other radiologists of the sponsor's choice.
Web-based technology platformOur 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 experienceWe 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.
To learn more about our Oncology services, please contact us.