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:
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.
This process includes but is not limited to the following:
Imagys’ rigorous quality control process ensures the image data received from the sites will be of the highest quality by enabling thorough and precise image data management and analysis. We accept DICOM or manufacturer specific formats.
Upon image upload the quality is controlled and any substandard image quality or violations of the imaging protocol are detected and refused. The end result is quality measurement data, delivered on time and within budget, all helping you to achieve statistical power of your study.
This process includes, but is not limited to the following:
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 Medical Device (MD) certified IIA class (new requirement as of 1 January 2010).
The Imagys medical imaging solutions for clinical trials allow you to protect important corporate assets by creating a long-term library of image data and to-date software. All imaging data is archived in the industry standard DICOM format and enables immediate access to images and trial data for potential use in future research, marketing and training.
Imagys offers storage of your image and results data, and the software used during the trial and also for a period of 15 years following the trial end date; guaranteeing piece of mind that the platform and imaging data generated can be presented “as used” during the clinical trial.
Imagys provides a sophisticated, integrated image repository and document management system which is fully customizable to your protocol. 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.
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.
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. To find out more about how we can help you call 00 33 2 40 92 26 13 or send us an email contact@imagys.com
