{"schemaVersion":1,"profileUrl":"https://nowen.ai/agents/oraclinical-com","markdownUrl":"https://nowen.ai/agents/oraclinical-com.md","jsonUrl":"https://nowen.ai/agents/oraclinical-com.json","name":"Ora","legalName":"Ora LLC","website":"https://oraclinical.com","industry":"Contract Research Organizations","deliveryModel":"services","status":{"trust":"unclaimed","text":"Unclaimed: compiled by Nowen from public sources, not reviewed by the company"},"updatedAt":"2026-11-12T18:22:42.830Z","summary":"Ora is an ophthalmology-focused clinical research organization supporting the development of eye treatments and medical devices through specialized research and clinical trial services.","description":"Ora is an ophthalmology-focused clinical research organization that supports innovators developing treatments and medical devices for eye conditions. It provides end-to-end clinical development capabilities, including trial design and execution, regulatory strategy, data and biostatistics, safety oversight, patient recruitment, and access to research sites. Its specialized teams support programs across development phases and therapeutic areas, with a focus on rigorous research and helping clients advance ophthalmic innovations toward approval.","mission":"Advancing ophthalmic product development.","directory":{"industryName":"Contract Research Organizations","agentCount":4,"indexable":false,"hubUrl":"https://nowen.ai/industry/contract-research-organizations"},"aiReaderFamilies":[],"products":[{"name":"Ophthalmic clinical development services","anchor":"product-ophthalmic-clinical-development-services","type":"Service","url":"https://oraclinical.com/clinical-success/","summary":"Advance ophthalmic programs with specialized clinical, operational, regulatory, data, and endpoint support from development through approval.","description":"Ora provides ophthalmic clinical research and product development services across development phases and therapeutic areas. Support includes trial design and execution, global site solutions, clinical tools and processes, safety and monitoring, regulatory strategy, data management and biostatistics, medical device development, and endpoint and technology development. Ora’s endpoint portfolio includes the Controlled Adverse Environment (CAE®), Conjunctival Allergen Challenge (Ora-CAC®), Allergen BioCube®, IVAD, Ocular Protection Index 2.0, EyeCup™, Visual Navigation Course (Ora-VNC™), and Lissamine Green staining. Ora reports experience across more than 35 ophthalmic indications, more than 3,000 programs, and over 90 product approvals.","pricing":{},"features":[{"name":"Clinical trial design and execution","value":"Design And Execute Ophthalmic Trials","valueDescription":"Shape protocols, recruitment, enrollment, and execution with ophthalmology-focused planning and operational support."},{"name":"Ophthalmic therapeutic expertise","value":"Apply Specialized Ophthalmology Expertise","valueDescription":"Work with teams experienced across ophthalmic indications and pharmaceutical and medical device development."},{"name":"Integrated trial management systems","value":"Unify Clinical Trial Management","valueDescription":"Bring trial management capabilities and data systems together, including CTMS, study start-up, monitoring, site payments, eTMF, EDC, and IRT."},{"name":"Safety and medical monitoring","value":"Provide Continuous Safety Oversight","valueDescription":"Apply ophthalmologist-led monitoring and strategic guidance, including adverse event review, eligibility assessment, safety reporting, and dose and toxicity oversight."},{"name":"Regulatory strategy and agency engagement","value":"Guide Regulatory Strategy And Engagement","valueDescription":"Prepare for regulatory discussions and align study designs and development plans with agency considerations."},{"name":"Data management and EDC services","value":"Manage Clinical Data End To End","valueDescription":"Support study data from collection design through database validation, cleaning, reconciliation, lock, and archival, with EDC implementation and support."},{"name":"Endpoint and technology development","value":"Improve Endpoint Precision","valueDescription":"Develop and refine ophthalmic endpoints to assess therapeutic impact, reduce data variability, and support efficient study designs."},{"name":"Clinical development lifecycle support","value":"Advance Programs Across Development Phases","valueDescription":"Access development support from program planning and study design through clinical research and regulatory submissions."},{"name":"Global site network and study operations","value":"Coordinate Trials Across Global Markets","valueDescription":"Access a global research-site network and local operational support for study feasibility, enrollment, monitoring, and data collection."},{"name":"Patient recruitment and retention","value":"Recruit And Retain Patients","valueDescription":"Support candidate screening, enrollment forecasting, scheduling, and personalized outreach to help align suitable participants with study protocols."},{"name":"Clinical master data and workflow automation","value":"Centralize Data And Automate Workflows","valueDescription":"Unify study information and documentation, reduce manual processes, and help identify site issues proactively."},{"name":"Clinical site monitoring","value":"Protect Safety And Data Integrity","valueDescription":"Support site performance, protocol adherence, subject safety, and reliable data while adapting monitoring to local requirements."},{"name":"Regulatory writing and meeting preparation","value":"Prepare Regulatory Documents And Meetings","valueDescription":"Organize development materials and prepare clear documentation and program input for agency discussions."},{"name":"Medical device regulatory support","value":"Navigate Device Regulatory Pathways","valueDescription":"Access regulatory consulting and clinical research support for ophthalmic device submissions and marketing applications."},{"name":"Biostatistical design, analysis, and reporting","value":"Analyze And Report Trial Data","valueDescription":"Apply statistical expertise to trial planning, analysis, validation, and reporting across development."},{"name":"Integrated clinical data reporting","value":"Consolidate Clinical Data Reporting","valueDescription":"Bring reporting together across clinical systems and centralize data to reduce redundant entry and support consistent sources of truth."},{"name":"Controlled Adverse Environment model","value":"Standardize Dry Eye Challenges","valueDescription":"Control environmental factors to support consistent assessment of dry eye treatment effects; CAE® is accepted as a primary endpoint for Phase 2 and 3 U.S. studies."},{"name":"Conjunctival Allergen Challenge model","value":"Evaluate Ocular Allergy Treatments","valueDescription":"Use controlled allergen exposure and adaptable study designs to assess anti-allergic treatments with validated severity scales."},{"name":"Allergen BioCube exposure model","value":"Control And Monitor Allergen Exposure","valueDescription":"Simulate pollen exposure with measured allergen release and real-time monitoring to support clinical evaluation of allergic rhinitis and conjunctivitis treatments."},{"name":"IVAD visual function assessment","value":"Measure Visual Function Objectively","valueDescription":"Assess visual function and therapeutic effects on ocular surface degradation using an endpoint validated by Ora as a secondary endpoint across three regions."},{"name":"EyeCup mobile data capture","value":"Capture Ocular Data Across Settings","valueDescription":"Collect images and timestamped patient data beyond the clinic, supporting broader data capture, customizable metrics, and reduced variability."},{"name":"Visual Navigation Course assessment","value":"Assess Functional Vision And Mobility","valueDescription":"Evaluate visual function and mobility with an adaptable course; the endpoint is FDA-accepted as a primary endpoint in the United States."},{"name":"Site coordination and technical support","value":"Support Sites With Study Activities","valueDescription":"Provide sites with coordinator, technical, and data-entry support for study visits, recruitment, procedures, enrollment, and study databases."},{"name":"Clinical intelligence and expert input","value":"Inform Decisions With Expert Insight","valueDescription":"Use ophthalmology perspectives to evaluate development decisions, pressure-test assumptions, and refine program strategy."},{"name":"Regulatory planning and risk mitigation","value":"Identify And Mitigate Regulatory Risks","valueDescription":"Consider key study and development requirements early and address potential risks that could affect plans or submissions."},{"name":"Statistical regulatory deliverables","value":"Prepare Statistical Regulatory Deliverables","valueDescription":"Support regulatory discussions and submissions with statistical consulting, data standards deliverables, and clinical study report review."},{"name":"Ocular Protection Index 2.0 system","value":"Assess Tear Film And Surface Protection","valueDescription":"Combine quantitative and qualitative tear film measures to assess instability and ocular surface protection."},{"name":"Lissamine Green staining assessment","value":"Assess Conjunctival Health","valueDescription":"Use staining to evaluate conjunctival health and support consistent assessment across visits."},{"name":"Clinical endpoint evidence and adaptability","value":"Tailor Clinical Assessments To Programs","valueDescription":"Select and adapt ophthalmic assessment methods to study objectives, therapy characteristics, and patient populations."},{"name":"Clinical technology training and compliance","value":"Equip Sites And Support Compliance","valueDescription":"Provide sites with training and round-the-clock helpdesk support while using processes designed to meet applicable guidelines and regulations."}]}],"audiences":[],"segments":[],"faq":[],"comparisons":[],"sources":[{"url":"https://oraclinical.com","text":"Ora"},{"url":"https://oraclinical.com/clinical-success/","text":"Ophthalmic clinical development services"}]}