Ora is a global ophthalmology-focused CRO headquartered in Andover, Massachusetts, providing end-to-end clinical development services for pharmaceutical, biotechnology and medical device companies. Founded in the 1970s, the company has over 45–50 years of experience dedicated exclusively to eye care research.

The company is recognised as a leading specialist in ophthalmic research, having completed more than 3,000 clinical projects and supported over 85 product approvals worldwide. Its exclusive focus on ophthalmology allows it to deliver deep therapeutic expertise across all subspecialties, including retina, glaucoma, cornea and inflammatory eye diseases.

Ora provides integrated services spanning preclinical development, clinical trials and regulatory strategy, helping clients bring ophthalmic drugs, biologics and medical devices from concept through to commercialisation. The company combines scientific expertise, proprietary methodologies and global clinical infrastructure to optimise study design, execution and outcomes.

With a global presence across North America, Europe, Asia and beyond, Ora supports multi-regional clinical trials and provides access to specialised ophthalmology research sites and key opinion leaders worldwide. The organisation works with a broad range of clients, from emerging biotech companies to large multinational pharmaceutical firms.

Key products and services

Clinical development services

• Phase I–IV clinical trial design and execution
• Global study start-up, monitoring and project management
• Patient recruitment and site network access

Ophthalmic therapeutic expertise

• Retina and macular diseases
• Glaucoma and optic neuropathies
• Cornea and ocular surface disorders
• Cataract and refractive conditions
• Inflammatory and autoimmune eye diseases

Regulatory and strategic consulting

• Regulatory pathway planning and submissions
• Pre-IND and scientific advisory support
• Global regulatory strategy and compliance

Data, biometrics and analytics

• Biostatistics and data management
• Integrated clinical data solutions
• Real-time analytics and reporting

Medical device and diagnostics support

• Ophthalmic device development and clinical trials
• FDA submissions and regulatory consulting
• Diagnostic and imaging device evaluation

Integrated drug and device development

• Preclinical models and translational research
• Clinical endpoint development and validation
• End-to-end support from discovery to post-market

By combining deep ophthalmology expertise with global clinical capabilities and integrated development services, Ora positions itself as a specialist CRO partner for eye care innovation. Its exclusive focus on ophthalmic research, strong track record of regulatory approvals and global trial execution capabilities enable pharmaceutical and biotechnology companies to efficiently advance therapies that improve vision and patient outcomes worldwide.