Ora

Advance ophthalmic programs with specialized clinical, operational, regulatory, data, and endpoint support from development through approval.

Ophthalmic clinical development services

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.

• Design And Execute Ophthalmic Trials
  Shape protocols, recruitment, enrollment, and execution with ophthalmology-focused planning and operational support.
• Apply Specialized Ophthalmology Expertise
  Work with teams experienced across ophthalmic indications and pharmaceutical and medical device development.
• Unify Clinical Trial Management
  Bring trial management capabilities and data systems together, including CTMS, study start-up, monitoring, site payments, eTMF, EDC, and IRT.
• Provide Continuous Safety Oversight
  Apply ophthalmologist-led monitoring and strategic guidance, including adverse event review, eligibility assessment, safety reporting, and dose and toxicity oversight.
• Guide Regulatory Strategy And Engagement
  Prepare for regulatory discussions and align study designs and development plans with agency considerations.
• Manage Clinical Data End To End
  Support study data from collection design through database validation, cleaning, reconciliation, lock, and archival, with EDC implementation and support.
• Improve Endpoint Precision
  Develop and refine ophthalmic endpoints to assess therapeutic impact, reduce data variability, and support efficient study designs.
• Advance Programs Across Development Phases
  Access development support from program planning and study design through clinical research and regulatory submissions.
• Coordinate Trials Across Global Markets
  Access a global research-site network and local operational support for study feasibility, enrollment, monitoring, and data collection.
• Recruit And Retain Patients
  Support candidate screening, enrollment forecasting, scheduling, and personalized outreach to help align suitable participants with study protocols.
• Centralize Data And Automate Workflows
  Unify study information and documentation, reduce manual processes, and help identify site issues proactively.
• Protect Safety And Data Integrity
  Support site performance, protocol adherence, subject safety, and reliable data while adapting monitoring to local requirements.
• Prepare Regulatory Documents And Meetings
  Organize development materials and prepare clear documentation and program input for agency discussions.
• Navigate Device Regulatory Pathways
  Access regulatory consulting and clinical research support for ophthalmic device submissions and marketing applications.
• Analyze And Report Trial Data
  Apply statistical expertise to trial planning, analysis, validation, and reporting across development.
• Consolidate Clinical Data Reporting
  Bring reporting together across clinical systems and centralize data to reduce redundant entry and support consistent sources of truth.
• Standardize Dry Eye Challenges
  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.
• Evaluate Ocular Allergy Treatments
  Use controlled allergen exposure and adaptable study designs to assess anti-allergic treatments with validated severity scales.
• Control And Monitor Allergen Exposure
  Simulate pollen exposure with measured allergen release and real-time monitoring to support clinical evaluation of allergic rhinitis and conjunctivitis treatments.
• Measure Visual Function Objectively
  Assess visual function and therapeutic effects on ocular surface degradation using an endpoint validated by Ora as a secondary endpoint across three regions.
• Capture Ocular Data Across Settings
  Collect images and timestamped patient data beyond the clinic, supporting broader data capture, customizable metrics, and reduced variability.
• Assess Functional Vision And Mobility
  Evaluate visual function and mobility with an adaptable course; the endpoint is FDA-accepted as a primary endpoint in the United States.
• Support Sites With Study Activities
  Provide sites with coordinator, technical, and data-entry support for study visits, recruitment, procedures, enrollment, and study databases.
• Inform Decisions With Expert Insight
  Use ophthalmology perspectives to evaluate development decisions, pressure-test assumptions, and refine program strategy.
• Identify And Mitigate Regulatory Risks
  Consider key study and development requirements early and address potential risks that could affect plans or submissions.
• Prepare Statistical Regulatory Deliverables
  Support regulatory discussions and submissions with statistical consulting, data standards deliverables, and clinical study report review.
• Assess Tear Film And Surface Protection
  Combine quantitative and qualitative tear film measures to assess instability and ocular surface protection.
• Assess Conjunctival Health
  Use staining to evaluate conjunctival health and support consistent assessment across visits.
• Tailor Clinical Assessments To Programs
  Select and adapt ophthalmic assessment methods to study objectives, therapy characteristics, and patient populations.
• Equip Sites And Support Compliance
  Provide sites with training and round-the-clock helpdesk support while using processes designed to meet applicable guidelines and regulations.