Industry Provider Profiles
Imagepace

• Imaging services for seamless clinical studies
• A new approval path for cardiovascular compounds: cIMT
• The complete answer to imaging
• ImageTrak ensures data is valid, timely and accessible
• Experts in an emerging field
• Medpace Group of Companies
• For More Information
• Contact Company

Imaging services for seamless clinical studies

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 DEXA .

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.

A new approval path for cardiovascular compounds: cIMT

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 regulatory requirements.

The complete answer to imaging

Imagepace handles the entire image collection process including:

• Study design and image protocol development
• Provision or coordination of standardized equipment
• Site selection and evaluation of on-site equipment applicability
• 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 ensures data is valid, timely and accessible

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.

Experts in an emerging field

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.

Medpace Group of Companies

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 development
• Medpace Clinical Pharmacology Unit (Medpace CPU): Phases I, IIa clinical development
• Medpace Reference Laboratories (MRL): Centralized laboratory specializing in cardiovascular and metabolic studies
• Imagepace: Imaging core laboratory providing centralized image management, and reading for pharmaceutical and biotechnology companies

For More Information

For more information about Imagepace, please contact Salvatore Zabbatino at 513-366-3266 or at info@imagepace.com.

For an exciting career move, visit www.imagepace.com and review our open positions in our career section.

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