Site Initiation Visits For Clinical Trials: Ocular Endpoint Planning For Sponsors And CROs

The Site Initiation Visit (SIV) is a critical milestone in clinical research, ensuring that investigators and staff are prepared to uphold Protocol integrity and Good Clinical Practice (GCP). For trials involving ocular endpoints, the SIV requires specialized planning due to the technical complexity of assessments like BCVA, OCT, and IOP. These endpoints are highly sensitive to environmental variability and equipment calibration, making standardized training and device validation essential for data reliability.

Key considerations for a successful ocular SIV include establishing inter-rater reliability (IRR) to reduce subjective bias and ensuring seamless integration between clinical sites and specialty vendors. Effective planning addresses common challenges such as extensive training timelines and the coordination of mobile or decentralized services. By prioritizing clear role definition and technical readiness during the SIV, sponsors and CROs can mitigate protocol deviations, enhance enrollment efficiency, and improve participant retention. Leveraging expert partners like 20/20 Onsite further streamlines this process by providing certified technicians, calibrated ophthalmic equipment, and audit-ready documentation, ensuring consistent execution across diverse research environments.