Rho has conducted over 50 ophthalmology clinical trials with more than 600 sites and 10,000 subjects. These studies cover the full range of drug development and include multi-protocol programs with several of the premier ophthalmology companies in the market as well as tailored CRO clinical trial services for virtual biotech and start-up companies. We have performed CDISC conversions and supported NDA submissions for ophthalmology products. Our experts have extensive experience interacting with FDA including the Center for Drug Evaluation and Research (CDER) Division of Transplant and Ophthalmology Products (DTOP).
Why choose Rho?
- Strong relationships with ophthalmic sites and investigators reduce study start-up time and ensure enrollment targets and timelines are met.
- Strong network of experts meets the needs of sub-specialization within ophthalmology including cornea, retina, glaucoma, and AMD/back of the eye specialists.
- Existing relationships with central reading centers that perform optical coherence tomography (OCT), fluorescein angiography, corneal and conjunctival staining, pachymetry, and gonioscopy.
- Familiarity with vision assessments and therapeutic specific training for clinical staff at the start-up of each trial ensures high-quality site monitoring. We also have experience using targeted SDV in ophthalmology trials.
- Experience with novel and sophisticated analysis methods to resolve challenges presented by the innovation and complex data typical to the field of ophthalmology and ophthalmology clinical trials.
- Statistical expertise creates an approach to protocol design and analysis that allows sponsors to use their data more wisely, such as increasing the power of existing results by using a repeated measure model.
- Use of EDC results in improved data quality.
- Our outstanding rate of customer retention (>90%) is a reflection of the high-quality work we do and the positive customer experience we create.
- Extensive expertise in marketing applications, statistical analyses, and submission data standards such as CDISC, leads to protocol development and study design that keep the end goal in mind.
Rho has ophthalmology experience in numerous indications including:
- Dry eye
- Glaucoma/ocular hypertension
- Vision and contact lens
- Ocular surface disease
- Vitreoretinal disease (including AMD)
Rho's CRO Services
- Integrated product development
- Clinical operations and monitoring
- Project management
- Medical monitoring
- Product safety and pharmacovigilance
- Biostatistics and statistical programming
- Clinical data management
- Regulatory operations
- Data standards and CDISC
- Regulatory and medical writing
- Quality assurance