Core Lab (iCRO) Services
Our imaging core lab’s expertise and services extend from translational to phase III and IV analysis and every step in between. We are imaging experts and have over 40 in-house radiologists that are specially trained in Oncology & Molecular Imaging, Neuroradiology & Spine Imaging, Musculoskeletal Imaging, Cardiac/Thoracic Imaging, Vascular & Interventional Imaging, Breast Imaging and Pediatric Imaging.
IE provides comprehensive imaging core lab services throughout the trial process. We can help with all aspects of trial planning and administration, and our quality management system ensures that all systems, procedures and data are fully compliant with applicable regulations, guidelines and regulatory expectations.
Our organization is unique in that our 40 in-house radiologists are owners of the Company. Radiologists that train and work together produce better results with less variability. As a result, we offer our clients the assurance they need that our specialists are among the best and can deliver the most accurate and reliable reads in the industry. Our radiologists currently perform reads for over 100 clinical trials. We understand the importance of study-specific training, meticulous analysis and the attention to detail that your trial deserves. And we specialize in performing economical real-time reads.
A brief description of just a few of our services is described below:
- Project Management and Reporting – we make your job easy!
- Development and Maintenance of a Master Project Management Plan and Timeline
- Imaging CTMS (iCTMS) for detailed and real-time subject/scan tracking, electronic query resolution and dashboard reporting
- Frequent and effective communication – the facts you need in the format you want
- Unparalleled service and client satisfaction
- Protocol development
- Participation at Kick-off and Investigator Meetings
- Creation of Imaging Review Charter in compliance with FDA Draft Guidance
- Site Imaging Manual preparation
- Electronic Data Capture: eCRF development, database build & validation
- Digital imaging transfer setup – global, real-time image transfer and receipt 24/7/365
- Development, validation, deployment and standardization with phantoms
- Clinical imaging site assessment, qualification and training
Study Conduct Services
- Scan receipt, QC and query resolution (real time)
- We work relentlessly to resolve queries – until they are resolved!
- Quick turnaround radiologist reads
- Rapid reads and reporting that meets your specific needs and budget
- Experienced Radiologists
- 40 in-house, board certified and subspecialty trained radiologists (owners of IE)
- Currently performing reads for over 100 clinical trials
- Excellence in analysis
- State-of-the-art analysis software
- Measure, minimize intra- and inter- reader variability and guarantee results
- Perfectionism in data management
- Efficient, effective and validated EDC
- Data monitoring and 100% QC verification
Study Closure and Reporting
- Data lock/clean and delivery of source data digitally
- Radiology Results Final Report
- Interrogates data and provides data tables, graphs and key images
- Statistical analysis available
- Subset analysis and comprehensive expert interpretation
- The most advanced imaging analysis reports in the industry
- Imaging components of regulatory submissions and support in regulatory meetings
- Imaging Endpoints works closely with you to provide excellent service that is customized to meet your needs. In addition to routine weekly and monthly communications, our Project Managers, as well as our Medical Director and other top Executives, quickly return your calls, and we provide our mobile phone numbers for issues that arise before or after business hours.
- We strive to be readily available to handle your questions and ensure your project needs are always met. We’ve grown our relationship with every client – all clients that started using our services have continued to use us for their subsequent imaging needs.