With the increased number of players involved in international clinical trials and the growing amount of imaging data being shared, Keosys has developed an advanced workflow management tool to share this data quickly within the complex regulatory framework. Keosys’ end-to-end proprietary technology platform, Imagys, allows for:
Keosys relies on its proprietary Imagys platform to manage every step of the clinical trials process from image acquisition at an investigator sites to data submission to the regulatory authorities. Our products allow all stakeholders to stay connected and informed throughout the trial on a global scale.
The imaging process starts at investigator sites, with medical images being uploaded by local users. Keosys provides training to each site and a login for Imagys (our secured web based platform for uploading these images) before any image can be uploaded. The software then performs an automated series of customizable quality control checks to ensure that correct images are being uploaded, which leads to greater operational efficiencies and increased quality.
As privacy concerns and requirements increase worldwide, Keosys is at the forefront of protecting patient imaging data and ensuring that no personal information leaves the hospital site. Our platform manages this process through an automated de-identification process developed internally by Keosys’ technology scientists. This process is in full compliance with both GDPR and HIPAA regulations.
The upload of DICOM images (across any modality) is a crucial part of the process, and Keosys aims to provide users with the fastest possible upload speed possible. This step is controlled by our Imagys Connector tool, which allows uploads to take place without monopolizing computer memory or needing supervision. This tool frees up time for users and leads to greater efficiencies.
Keosys works with sponsors across the world and has data centers in all major continents to ensure that our data is available in real time. These data centers are fully compliant with existing regulations and have successfully supported both FDA and EMA applications. We also comply with EU GDPR data hosting requirements and can support data in the location most suitable for each sponsor. We are able to support multiple data formats and integration with most EDC systems.
Once the imaging data has been transferred to our data centers, we perform a manual quality control check to ensure images are suitable to be read by radiologists and also comply with our Image Acquisition guidelines (which we write specifically for each study). Trained technicians review the images and either accept or reject them based on those guidelines. We also include a query management tool with the software to allow communication between sites and quality controllers.
We provide all physicians reading for a given trial with training on our Read System and the protocol itself before they start reading sessions. Our Read System is seamlessly integrated with our Imagys platform, reducing manual human entries and increasing data quality traceability. Our software is compatible with all commonly used reading criteria, including RECIST, iRECIST, mRECIST, CHESON, RANO, PCWG3 and more.