Ora

Overview

Ora Clinical is a global full-service firm specializing in ophthalmic drug and device development, with over 50 years of experience. The company has supported more than 85 product approvals and conducted over 3,000 clinical projects. Headquartered in Andover, Massachusetts, the organization operates worldwide, with teams across North and South America, Europe, Asia, and Australia.

The company offers comprehensive support throughout all phases of ophthalmic product development, including preclinical and clinical development, regulatory consulting, and clinical trial management using advanced tools for efficient data capture and compliance. Ora Clinical has a strong focus on patient and site engagement, particularly in large retinal trials, and has developed proprietary tools such as the Ora EyeCup™, a mobile research platform for high-resolution imaging and AI analysis. Its expertise covers various therapeutic areas within ophthalmology, such as cornea and ocular surface, retina and macular diseases, glaucoma, and inflammatory conditions.

Basic Information

Contact Details

• Phone: +1 978-685-8900
• Website: oraclinical.com
• LinkedIn: linkedin.com/company/ora-llc

Key Focus Areas & Initiatives

• Allergy
• Antiinfective
• Glaucoma
• Retina
• Medical devices
• Drug delivery
• Dry eye
• Antiinflammatory
• Pharmaceutical manufacturing
• Consulting
• Product approvals
• Clinical research services
• Regulatory pathway planning
• Ophthalmic surgical device trials
• Patient-specific endpoints
• Clinical endpoints
• Data integrity
• Regulatory support
• Regulatory consulting
• Ophthalmic drug delivery systems
• Under-served patient populations
• Regulatory approvals
• Global ophthalmic trial network
• Ophthalmic product pipeline
• Retinal disease progression markers
• Pharmaceuticals
• Ophthalmic imaging
• Medical imaging
• Ophthalmic innovation
• Imaging endpoints
• Clinical project management
• Biostatistics
• Ophthalmology
• Regulatory filings
• Clinical monitoring technology
• Clinical data analysis
• Clinical trial design
• AI platforms
• Product development
• Clinical success rate
• Clinical trials
• Clinical research
• Retinal imaging endpoints
• Clinical trial recruitment
• Clinical trial remote monitoring
• Ophthalmic device safety testing
• Clinical operations
• Research lifecycle
• Clinical trial reporting
• Regulatory submissions
• Drug development
• Medical device development
• MIGS device trials
• Diagnostic imaging
• Ocular surface disease models
• Drug and device approval
• Clinical trial efficiency
• Clinical trial optimization
• Global clinical sites
• Clinical data management
• Biotechnology
• Ophthalmic clinical data management
• Regulatory strategy
• Ophthalmic research
• Biometrics
• Retinal disease biomarkers
• Visual acuity testing platforms
• Medical device trials
• Biostatistics services
• Data analytics
• AI in ophthalmic diagnostics
• Trial site management
• Healthcare
• Regulatory compliance
• Patient engagement
• B2B
• Ophthalmic device regulatory pathway
• Global regulatory compliance
• Ophthalmic diagnostics
• Retinal disease progression tracking
• Clinical trial automation
• Regulatory strategy support
• Advanced ophthalmic imaging
• Medical device regulation
• Ocular inflammation studies
• Dry eye biomarker development
• Innovative clinical endpoints
• Ocular surface disease endpoints
• Ophthalmic CRO
• AI-driven image analysis
• Clinical development
• AI diagnostics
• Research and development in the physical, engineering, and life sciences
• Endpoint development
• Clinical protocol development
• Ocular surface
• Patient-centric trial design
• Clinical monitoring
• Product registration
• Regulatory affairs
• Ophthalmic imaging technology development
• Ophthalmic therapeutics
• Patient data collection
• Regulatory strategy for ophthalmic devices
• Clinical trial execution
• Regulatory pathway
• Medical innovation
• Clinical trial technology
• Clinical trial logistics
• Patient recruitment
• Clinical success
• Ophthalmology expertise
• Clinical trial innovation
• Retina disease clinical trials
• Site network
• Precision medicine in ophthalmology
• Data solutions
• Clinical trial endpoint innovation
• Clinical trial partnerships
• Clinical trial patient stratification
• Ophthalmic biomarker validation
• Regulatory approval process
• CRO
• Refractive
• Blepharitis
• Drug approvals
• Clinical expertise
• Data biostatistics
• Safety monitoring
• Site solutions
• Endpoint technologies
• Clinical tools
• AI-driven analysis
• Ophthalmic innovations
• Trial design
• Therapeutic areas
• Patient populations
• Research technology
• FDA submissions
• Market applications
• Visual navigation
• Controlled adverse environment
• Mobile clinical platform
• Ocular imaging
• Disease treatment
• Biopharmaceuticals
• Nonclinical program
• Collaborative studies
• Evidence-based
• Healthcare solutions
• Biometric data
• Clinical trial management
• Personalized treatment
• Research methodology
• Novel therapies
• Patient compliance
• Real-time data capture
• Hospital & health care
• Medical
• Health care
• Health, wellness & fitness

Technologies Used

• Akamai Connected Cloud (formerly Linode)
• Dyn Managed DNS
• Google Tag Manager
• Gravity Forms
• Greenhouse.io
• Microsoft Excel
• Microsoft Office 365
• Mobile Friendly
• OnCore CTMS
• Outlook
• Proactis Rego
• Rackspace MailGun
• Remote
• Salesforce
• Shutterstock
• Slack
• Typekit
• Veeva Vault eTMF
• Vimeo
• WP Engine
• WordPress.org

Affiliated Organizations & Regional Branches