Ophthalmology

Identifying and enrolling patients with specific eye conditions can be difficult, particularly when the symptoms are mild or the condition is rare. Ensuring long-term participation is essential but challenging.

iNGENū CRO addresses this pain point with Targeted Recruitment Strategies

iNGENū utilises a combination of advanced patient databases, partnerships with ophthalmology clinics, and engagement with patient advocacy groups to identify and enroll suitable candidates efficiently. We prioritise patient-centric trial designs to enhance recruitment and retention.

Ophthalmic studies often require advanced imaging techniques such as Optical Coherence Tomography (OCT), fundus photography, and fluorescein angiography. Consistency and accuracy in these diagnostics are critical.

iNGENū addresses this pain point with State-of-the-Art Imaging

We partner with leading ophthalmology centers equipped with the latest imaging technologies. Our trials incorporate standardised imaging protocols and training for site staff to ensure consistent data collection across all sites.

Many ophthalmic conditions rely on subjective patient-reported outcomes (PROs) and visual acuity measures, which can introduce variability in data collection and interpretation.

iNGENū addresses this pain point with Objective and Subjective Outcomes

We design trials that incorporate both objective measures (e.g., imaging biomarkers, visual function tests) and validated subjective outcomes. Our statisticians are adept at analyzing complex data sets to account for variability in patient-reported outcomes.

Ophthalmology trials often involve complex regulatory pathways, particularly when dealing with innovative treatments such as gene therapy, biologics, or medical devices.

iNGENū addresses this pain point with Regulatory Expertise

iNGENū's regulatory affairs team is well-versed in the specific requirements for ophthalmology trials. We provide comprehensive support, from IND/IDE submissions to navigating the approval processes for innovative treatments.

Given the sensitivity of the eye and the potential for adverse events, particularly in surgical interventions or invasive procedures, vigilant safety monitoring is crucial.

iNGENū addresses this pain point with Robust Safety Monitoring

Our safety protocols include continuous monitoring, real-time data analysis, and a dedicated safety board to oversee the well-being of participants. We also emphasise clear communication with all stakeholders to manage risks effectively.