Enhancing Phase 1 Clinical Trials with Point-of-Need Ocular Safety Assessments

Syneos Health, a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success, encountered an obstacle during a Phase 1 study. As part of ocular safety assessments in Phase 1 clinical trials, the study protocol required monitoring for potential ocular side effects, adverse events, and changes in visual acuity and retinal health. However, the clinic lacked the specialized ophthalmic equipment and personnel needed to conduct comprehensive eye exams, including slit-lamp evaluations and intraocular pressure (IOP) measurements, required to meet safety assessment standards and good clinical practice.

To address this specific need, 20/20 Onsite deployed the Mobile Clinical Suite (MCS) at the Syneos Health Miami Phase 1 Unit to support ocular safety assessments in Phase 1 clinical trials. This customized exam room, complete with advanced ophthalmic equipment and experienced staff, enabled comprehensive eye exams, including visual acuity, slit-lamp, and retinal evaluations, without patients needing to travel off-site. The MCS facilitated convenient participation, maintained data integrity, and ensured compliance with Phase 1 clinical trial protocols and good clinical practice standards.

• Slit-lamp Examination
• Retinal Imaging
• Direct/indirect Ophthalmoscopy
• Visual Field
• Near Vision J Reading

Syneos Health avoided significant investment in equipment and staffing while gaining access to specialized resources, and the study became more cost-effective for the sponsor as well.

Onsite ophthalmic safety assessments ensured patients received high-quality care within the familiar clinic environment while seamlessly integrating into the clinic workflow, supporting protocol compliance and consistent safety monitoring.

Our MCS provided the missing link necessary to execute Phase 1 ocular safety assessments within this clinical trial. The collaboration also opened new doors for Syneos Health, whose team previously faced challenges coordinating off-site ophthalmic evaluations.

Building on this success, Syneos Health and 20/20 Onsite are collaborating on additional Phase 1 trials, further demonstrating the adaptability and impact of the MCS across diverse clinical research settings.

Visit our website or contact us today to schedule a consultation and explore how our point-of-need solutions can support your clinical research.