Contract Research Organizations
The drug discovery process is complex and challenging. The clinical stage is resource intensive, demanding and high risk. A fine balance is required to execute this stage correctly.
Clinical Research Organizations (CROs) support drug manufacturers and study sponsors on their road to discover and approve drugs of the future by absorbing some of the clinical stage’s burdens. Data research, project management, tests, trials that are run post approval, pre-clinical and clinical are just some of the activities covered.
This relationship, which is built on trust and skill, can award manufacturers with heightened expertise as well as cost and time efficiencies. These benefits come at the cost of duties such as intensive communication management, confidentiality concerns and regulatory considerations.
Many established Contract Research Organizations have elected to integrate and use the EyeKor platform to manage the imaging and data management elements of their clinical studies. This architecture provides users with a host of benefits. It requires little onsite management and no onsite image storage, enables secure use of the platform by multiple users, is scalable for image and data storage expansion, and provides easy control of access to the system. Upload and download rates have been optimized to ensure that images and other data can be processed and analyzed quickly by users. EyeKor’s EXCELSIOR™ platform received 501 (k) clearance from the U.S. Food and Drug Administration and meets all US and EU standards.
Reading Centers are an integral part of ophthalmic clinical trials. A positive study outcome is always build on strong data derived from the efficient, accurate collection and interpretation of ocular imaging.
Given the diverse array of new and improved imaging technology now available to document and measure biomarkers and treatment efficacy in clinical trials, reading centers are becoming more specialized and many are focusing their expertise on the interpretation and analysis of very specific imaging technology. It is now common practice for clinical trial sponsors to engage the services of multiple reading centers to provide the specialist analysis they require to meet their study endpoints.
EyeKor collaborates with multiple reading centers worldwide and EXCELSIOR™ manages ophthalmic images of virtually any format. It allows image tracking and grading data in real time, and measure progress against the goals set by the trial’s sponsors. EXCELSIOR™’s workflow is easily customized to meet the specific requirements of any reading center. It’s precision and performance have been proven around the world, supporting the collection, storage and analysis of more than 10 million images.
Imaging Technology manufacturers
Imaging of the eye is critical to improving the diagnosis, assessment of severity and progression, and evaluation of management of eye disease. Advances have been rapid, with improvements in hardware, optics and software. The technology and clinical application of ocular imaging techniques of photography, Scheimpflug imaging, scanning laser ophthalmoscopy, scanning laser polarimetry, ultrasonography, optical coherence tomography, confocal scanning microscopy and OCT angiography are transforming ophthalmic imaging.
The incorporation of Adaptive optics, and software, such as noise-reduction algorithms allow imaging down to cellular level and continues to improve our understanding of the disease process and the biological variability of eyes. The incorporation of these novel technologies into clinical trials are often the first steps in the utilization of these technologies into general clinical practices. EyeKor is at the front line in working with the manufactures of these technologies to incorporate these new images seamlessly into our platform.