06 avr 2010

Imagys, your partner for medical imaging solutions in clinical trials

imagys_logo_130Imagys was founded by telecommunications and imaging experts, and we understand how
the use of imaging in clinical trials can decrease costs, accelerate timelines and help
improve the probability of success.

A division of Keosys, leader in medical imaging and communication systems for nuclear
medicine (NM, SPECT/CT & PET/CT) and radiology (CR, CT, MG & MRI), Imagys draws on extensive technology and expertise from keosys' 30 strong team. 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.
Already contracted with the EORTC and other Europe-based sponsors, Imagys partners with pharmaceutical, biotech and medical device sponsors, CROs and research institutions to streamline your clinical workflows by reducing time to study endpoints.

 

Study Set-Up


Study set-up is one of the most demanding and time-critical components of trial management. Imagys assists your team for a smooth and effective study initiation by designing an imaging protocol and review charter, drawing up communication plans and project-specific instructions, conducting onsite and/or webbased training.

 

Read Methodology Process


Together with your team, Imagys helps you in designing and developing your read methodology, either prior to patient enrollment or in conjunction with the receipt and on-going quality control of the image data.

 

Quality Control


The Imagys image management portal is a 21-CFR part 11, ISO 9001 and ISO 13485 Medical Device compliant solution that consists of intuitive image upload software, a customizable database and a web-portal that centralizes all activity between you, your trial site and an Imagys project manager.

 

Secure and Easy Image


Submission and Archiving Imagys' innovative software allows investigators from multi-centre sites anywhere in the world to upload imaging data, eCRFs and supporting documentation to the data centre requiring only an internet connection and minimum OS requirements (Windows 2000, XP, vista, or Seven). Storage and archiving on a central server certified DM Class IIA (new requirement as of 1 January 2010).

 

Real-time trial visibility via comprehensive web-portal


The Imagys platform is a sophisticated, integrated image repository and document management system which is fully customizable to your protocol and provides a secure, real-time view of trial-specific data from anywhere in the world. The database links all formats of medical images: CT-Scans, MRI, X-rays, Ultra-sound, PET/CT, SPECT/CT, NM and medical photography; eCRFs and supporting documentation.

 

Real-time tracking and stringent audit trails


With Imagys you can be assured that images fully meet your protocol specifications, are
secure and compliant with 21-CFR part 11, ISO 9001 and ISO 13485 Medical Device standards. You can be assured that each stage of the trial which involves Imagys is secure and traceable in real-time offering you a stringent audit trail.

 

Consulting


As your partner in medical imaging solutions for clinical trials we can provide a team of
telecommunications and imaging experts to develop bespoke in-house solutions for your specific trial protocols, in addition to our outsourced solutions.

imagys_workflow

To find out more about how we can help you call 00 33 2 40 92 26 13 or send us an email
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