“Increasingly, global clinical trials are including multimodality medical imaging procedures such as PET, MRI, CT, and Nuclear Medicine utilizing medical imaging as either primary, secondary, or surrogate endpoints and possibly even biomarkers. Sponsors of diagnostic, therapeutic and medical device clinical trials are in need of greater standardized and centralized image collection and review solutions generating access and reported results within 24 – 48 hours of medical images being submitted for radiology review. The combination and global integration of our clinical, scientific, and core lab expertise of both organizations increases the sponsors ability to meet this need. KEOSYS technologies for WEB image collection, management and analysis associated to eImages’ expertise in clinical trials design, development and management, makes us natural alliance partners.,” says Sylvie Davila, MBA, Director of Business Development, KEOSYS. “The alliance couples both organizations vast experience in conducting and managing eClinical research trials for oncology, cardiology, CNS, infectious disease, musculoskeletal, vascular and other disease states with a medical imaging component along with prior extensive medical imaging CRO experience offering unprecedented solutions for the pharmaceutical, biotechnology, and medical device industry in drug and device development.”
“We are extremely excited to enter this strategic partnership with KEOSYS leveraging the efficiencies from both of our technologies, expertise and solutions offering clinical trial sponsors increased ROIs. The most critical step of any clinical trial is receiving the data, including medical images, in a timely manner. Doing so confirms protocol and regulatory compliance leading to efficient standardized radiology review of the images using perhaps RECIST, Cheson or other criteria along with associated clinical data. KEOSYS and eImage solutions will provide substantial efficiencies of independent radiology review using central, standardized image interpretation methods for various medical imaging endpoints. The implementation of these real-time eClinical trial solutions will provide sponsors and CROs with increased, manageable capabilities for overall project requirements such as subject eligibility using tumor size or ejection fraction results as examples.” John Ceccoli, MBA, President and CEO of eImage, Inc. states. “Significant technology advancements in electronic data collection and transmission along with WEB software development tools have created a whole new platform for eClinical trials. As medical imaging data from PET, MRI, CT, Nuclear Medicine and various other modalities are acquired in electronic format, images can be transmitted rapidly to ONE central location and reviewed locally or remotely by central reviewers (radiologists and/or clinicians) all via WEB technologies. Clinical trial sponsors and CROs will benefit the most resulting in all image and/or clinical data being reviewed using standard criteria, easily archived in common formats such as SAS transport file and available for immediate upload into a clinical database.”
KEOSYS and eImage will utilize and expand upon the use of KEOSYS development partner, Imagys full web platform, implementing the alliance’s common technical platform for image data de-identification, collection, storage and management including eCRF functionality, unrivaled security meeting all global regulatory requirements, and centralized collection, analysis and turn-around of image data and eClinical data.
KEOSYS and eImage will continue to operate in their originally contracted fashions for current sponsors while sharing in business development, operations, clinical, and management activities for all other future functions.
About KEOSYS: KEOSYS, established in 2001, is a Leader in Medical Imaging IT applied to Clinical Research and Medical Diagnosis with nuclear medicine (NM, SPECT/CT & PET/CT) and radiology (CR, CT, MG, US & MRI) fields, providing unmatched central and standardized collection, management, and analysis medical imaging solutions. Our areas of expertise include streamlining clinical workflows by reducing time to study endpoints for radiology and medical imaging trials. Through our innovative technology development, Imagys cloud web platform, we have already contracted with the EORTC and other Europe-based sponsors conducting and managing clinical imaging trials for pharmaceutical, biotech and medical device sponsors, CROs and research institutions. Additionally, KEOSYS has extended their activities in the US Market with a recently signed contract with the Society of Nuclear Medicine Clinical Trials Network (SNM-CTN) providing solutions for the phantom imaging program and biomarker studies. Imagys web solution was developed by telecommunications and imaging experts, who understand how the use of imaging in clinical trials can decrease costs, accelerate timelines and help improve the probability of success. With over 5 years research and development invested in innovative medical imaging solutions for clinical trials, Imagys was launched in November 2009 using advances in internet-based technology and security to simplify and revolutionize the clinical trial process for any volume of images.
For more information at KEOSYS, please contact:
Sylvie DAVILA, PhD/MBA
Business Development Manager
Clinical Project
KEOSYS Medical Imaging
1 Impasse Augustin Fresnel
44815 SAINT HERBLAIN
FRANCE
+33 6 65 57 78 00
+33 2 40 92 26 13
sylvie.davila@keosys.com
www.keosys.com
About eImage, Inc.: eImage, Inc. is a medical imaging core laboratory and e-clinical trials informatics solutions company offering clinical trials management services and products for drug and medical device development, from early Pre-Clinical to Phase I-IV trials with the use of MRI, CT, Nuclear Medicine, PET, Ultrasound, Angiography, and general X-Rays, in the diagnosis and treatment of oncology, cardiovascular, CNS, infectious disease, vascular, musculoskeletal and other diseases. We offer solutions in clinical trials management services and products to pharmaceutical, biotechnology, and academic core laboratories focusing on novel drug and device development strategies for use as biomarkers, in-vivo diagnostic tools, and therapy medicines while leveraging technology in the collection, management, and central analysis of medical imaging and clinical data. eImages’ vast experience in conducting and managing clinical research trials with a medical imaging component include pre-study site qualifications, on-study training and review, developing imaging protocols, manuals, imaging charters, WEB centralized collection, management, and analysis of images, WEB/Remote image review, conducting independent radiology (and clinical) assessments, and reporting interim and final report data to study sponsors and regulatory agencies. eImages’ expertise comes from 24 “hands on” years experience establishing several medical imaging CROs, managing various clinical trials, medical imaging software development and in addition, participates as a member of the Society of Nuclear Medicine Clinical Trials Network (SNM-CTN).
For more information at eImage, Inc., please contact:
John Ceccoli, MBA
President & CEO
eImage, Inc.
650 Sentry Parkway
Suite 1
Blue Bell, PA 19422
phone: 215-715-7683
fax: 866-620-8830
email: jceccoli@eimageinc.com
www.eimageinc.com
