Study Management Expertise
EyeKor specializes in providing masked, independent, central reading services in support of ophthalmology clinical trials, from Phase I to post-marketing. We manage all imaging components of the clinical trial to ensure the guidance necessary for success. EyeKor’s project management team supports sponsors, CROs, and sites with status reporting and communication at all stages of the study. The assignment of two project managers for each study - a primary PM as a the main point of contact and sponsor resource, as well as a secondary PM to provide backup support - ensures continuity and aims for an exceptional client experience.
Study Management Platforms
The EXCELSIOR™ platform is utilized on a daily basis for trial organization and management. Progress is tracked in EXCELSIOR™ to manage all facets of each study, including site status, image transfer and receipt, image quality control and processing, independent reviewer assessments and centralized reporting. Contact between EyeKor, the sponsor and the sites is facilitated through FreshDesk, a cloud-based customer support system. An email to firstname.lastname@example.org creates a traceable ticket that EyeKor Support Team responds to within 24 hours of receipt.
Project Management Services
EyeKor’s role in the management of study imaging components specifically includes:
- Management of all phases of the study, from start-up to maintenance and close-out
- Management all imaging sites' personnel and equipment
- Ensuring study-related activities occur per specified timelines
- Creating and distributing study-specific documents
- Hosting study team teleconferences
- Presenting and training at investigator meetings
- Organizing EyeKor study team training
- Scheduling reviewers to complete study reads as needed
- Providing status reports to sponsors on a regular basis
- Escalating site image quality concerns and ensuring appropriate action plans are implemented
- Ensuring proactive adherence to applicable SOPs, including completion of required internal documentation and expedient action on internal and external audit findings.