Imaging partnership boosts trial efficiency	February 2009

By Colette Pilkus

Many challenges face companies who manage and deliver clinical trial imaging data to clients. Contract research organizations must collect and standardize the images acquired across sites throughout the world, anonymizing the images while ensuring a trail to prove the source, and centrally evaluating each image according to the project criteria in a compliant manner. The launch of a new partnership between CRO Bio-Imaging Technologies Inc. and AG Mednet, a global diagnostic imaging network, may help simplify the contracting and implementation process for clients to a single line item, while Bio-Imaging manages all of the details.

AG Mednet's clinical trials imaging network is specifically designed for investigator sites and trial managers. At the site, a Web-enabled agent guides trial managers through a process to send the image studies and data directly to the imaging core lab. The process usually takes minutes, compared with previously used methods that have taken hours or days.

AG Mednet’s extensive network is designed to route diagnostic images for the most advanced studies, ranging from small computed tomography and magnetic resonance imaging to larger computer tomography angiography, magnetic resonance angiography, and intravascular ultrasound images.

"This partnership enables faster transmission of images to Bio-Imaging's imaging core lab, and the network's advanced de-identification capabilities will expedite analysis, increase data quality, and ultimately, reduce the time it takes to conduct clinical trials," says Abraham Gutman, president and CEO, AG Mednet (agmednet.com).

To transfer images, investigator sites only need Internet access, while a desktop agent provides investigators with simple access to the imaging network. A workflow tool quickly imports image studies, de-identifies them, completes transmittal forms with validation of protocol-specific requirements, and sends the image studies directly to the appropriate trial repository.

"Moving images electronically rather than with a courier is a key enabler; the real benefits result from our collaboration to deploy and support the service for optimal results," says Mark Weinstein, president and CEO, Bio-Imaging Technologies (bioimaging.com). "When the sites send the clinical images faster, and the processes to manage them take full advantage of the technology, the result is improved speed and a reduction in errors associated with manual steps. Bio-Imaging’s partnership with AG Mednet puts all the technology and service pieces together to ensure results."

According to Mr. Gutman, the partnership extends Bio-Imaging’s offerings by giving the company tools to assist in validating data entry and capabilities to de-identify images, resulting in a reduction of the number of queries sent back to sites. Electronic submissions will reduce the overhead involved in extracting images from CD and eliminate transmittal-form data entry, translating into higher quality data, enhanced site compliance, and faster trial timelines.

Mr. Gutman believes that more pharmaceutical companies are adopting newer methods in clinical trial image delivery to reduce unnecessary queries and increase data accuracy, while also enhancing the ability to record and monitor time points free of errors.

"There is an active effort on the part of sponsors to increase data quality and site compliance, as well as to enhance site monitoring related to image submission in a manner that adds no burden to investigator sites while integrating with the processes of their core lab partners," Mr Gutman says. "Additionally, as the desire to perform eligibility interpretations increases, the need for real time delivery of images is paramount."