Imaging CRO (Core Lab) Services
Our project teams consist of project managers, medical and scientific affairs experts, data managers, radiology technologist and compliance experts with vast experience in both early and late-stage trials. Our Imaging Clinical Trial Management System (iCTMS) and reporting processes enable us to make your job easy by providing the real-time information you need in the format you want. Our services are tailored to match your project’s unique objectives, timelines and budgets while providing the agility needed in a clinical trial partner.
We have a remarkable track record for customer satisfaction; the continued success of our business depends on the success of yours, so we work with you in a climate of collaboration and long-term partnership. We strive to not only meet your needs but exceed your expectations.
96+ Expert Radiologists, Oncologists, Surgeons and Other Specialty Physicians:
Our organization is unique in that we have over 96 physician readers comprised of 40 in-house radiologists, globally recognized expert clinical trial radiologists, oncologists, surgeons and other U.S. based medical specialists and scientists. With our experience in hundreds of successful clinical trials, we know and trust the radiologists and physician-scientists who will contribute critical data to your trial and are proud to stand behind their extensive expertise in their subspecialty disciplines. IE provides the CVs of its proposed expert readers to its sponsors for consideration and approval.
A brief description of just a few of our services is described below:
- Expert Project Managers and a unique Project Team design
- 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
- Setup of electronic TMF and iCTMS
- Creation of Imaging Review Charter in compliance with FDA Guidance
- Imaging site assessment and qualification
- Site Imaging Manual preparation and site training
- Digital imaging transfer setup – global, real-time image transfer and receipt 24/7/365
- Standardization with phantoms
- Reader selection, reader training and training verification
- Data Management Plan, Data Validation Plan, Data Transfer Specifications
- Scan receipt, QC and query resolution (real time)
- We work relentlessly to resolve queries – until they are resolved!
- Expert reads (real time)
- Rapid reads and reporting that meets your specific needs and budget
- Experienced Radiologists
- 96+ in-house and expert board certified and subspecialty trained radiologists and other physician specialists (oncologists, surgeons, etc.)
- Currently performing reads for hundreds of clinical trials
- Excellence in analysis
- State-of-the-art cloud-based analysis software
- Measure, minimize intra- and inter- reader variability and guarantee results
- Excellence in data management
- Real time data monitoring and verification of reads
- Data exports on a scheduled or as-needed basis
Study Closure and Reporting
- TMF maintenance and closure
- Perform routine reconciliation
- Perform all tasks required to clean and lock the imaging database
- Imaging data maintenance and closure
- Maintain image archive and perform routine reconciliation
- Final delivery of TMF and images with viewing software
- Secure cloud-based storage with backup of all data
Imaging Endpoints works closely with sponsors to provide excellent service that is customized to meet their needs. In addition to routine weekly and monthly communications, our Project Managers as well as our Scientific Affairs team and top management quickly return calls, and we provide 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!
Imaging Endpoints works with some of the largest pharmaceutical and biotechnology companies as well as many medium and small companies. Some of our clients have had the opportunity to evaluate our science and services vs. competitive imaging core labs. We are pleased to be able to provide excellent references.