Industry Provider Profiles
Company Type Services
Imagepace offers a seamless set of services to connect imaging
requirements with other clinical components of the study. The
centralized core lab manages standard, as well as innovative,
imaging modalities, including MRI, CT, PET, X-ray, ultrasound, and
In cardiology, Imagepace is the global leader in the use of
carotid intima-media thickness (cIMT) as a measure of
atherosclerosis progression in clinical trials. These services
include central reading of images, a network of imaging sites, and
a coordinated data management system.
Led by a team of cardiology specialists, Imagepace has refined
the technology and processes of carotid intima-media thickness
(cIMT) imaging. cIMT is emerging as the key validated method of
directly measuring atherosclerosis progression.
With a network of imaging sites, Imagepace utilizes standardized
training and processes to conduct clinical trials with a cIMT
endpoint. Centralized reading is provided at one of three
facilities, located in the US, Europe, and China. At all Imagepace
centers, images are read by Image Analysts who have been formally
trained. They use identical hardware and software and follow
identical standard operating procedures (SOPs).
Imagepace uses state-of-the-art validated technologies that meet
21 CFR Part 11 criteria and adhere to U.S. and international
Imagepace handles the entire image collection process
- Study design and image protocol development
- Provision or coordination of standardized equipment
- Site selection and evaluation of on-site equipment
- Maintenance oversight and reporting, including analysis of
impact on data validity
- QA/QC, including site and equipment audits
- Study-specific training and certification of site staff
- Certified centralized reading services
- Database integration
- Regulatory submission preparation
- Seamless integration with other study-related services such as
IVRS, Web-based reporting, and study management
ImageTrak stores and manages the data from all imaging and
reading centers. This powerful, proprietary software program
integrates image tracking, quantitative and qualitative analysis,
and data management.
Whatever the study, ImageTrak readily handles the images and
data -- even analog images from previous studies that were not
created in a digital format. Analysis can be performed for
inclusion/exclusion criteria assessment, on an ongoing basis
throughout the study, and as a batch analysis as subjects complete
the study. All analyses can be performed in a blinded fashion based
on study-specific requirements.
Technician feedback and reporting are built in, so imaging
centers can quickly identify and correct any potential issues.
ImageTrak also provides timely status reports so sponsors can track
the progress of the study.
The Imagepace team brings vast clinical trial experience to the
disciplined management of imaging services.
International thought leaders and experts in the use of cIMT as
a surrogate endpoint, John Kastelein MD (Europe) and Daniel
O'Leary MD (North America) are integral members of the
Imagepace management team.
Imagepace is a vital part of the Medpace group of companies.
Medpace is a global, research-based drug development company led by
top therapeutic and regulatory experts who are driven to further
the advancement of pharmaceutical agents for use in cardiology,
metabolism, and oncology. Medpace has assembled the industry's
most experienced and therapeutically focused team to execute at all
levels of the company's operations, providing complete and
seamless drug development services.
With clinical trial experience in 40 countries, Medpace has the
global reach and capability to conduct studies and navigate
regulatory requirements worldwide. The Medpace approach creates
therapeutically focused project teams and increases the quality of
every service we offer.
Medpace Group of Companies:
- Medpace CRO: Phases IIb, III, IV clinical
- Medpace Clinical Pharmacology Unit (Medpace
CPU): Phases I, IIa clinical development
- Medpace Reference Laboratories (MRL):
Centralized laboratory specializing in cardiovascular and metabolic
- Imagepace: Imaging core laboratory providing
centralized image management, and reading for pharmaceutical and
For more information about Imagepace, please contact Salvatore
Zabbatino at 513-366-3266 or at
For an exciting career move, visit
www.imagepace.com and review
our open positions in our career section.
Patricia E. Cole
4620 Wesley Avenue
Cincinnati, OH 45212
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