Ora

Ora supports drug development for ocular diseases with consulting as well as compound synthesis, formulation development, analytical testing, and manufacturing services.

As the world leader in ophthalmic clinical trials, Ora provides a complete range of development services, including preclinical models, clinical research and development, regulatory strategy, statistics and data management, medical writing, and marketing and advertising services. We bring together the world’s most extensive and experienced network of ophthalmic experts, investment partners, and industry-leading companies in order to bring new drugs, drug delivery systems, and medical devices to market. Over the past 30 years, Ora has earned 34 regulation product approvals for our clients. Today, our validated, industry standard models and established methodologies continue to generate accurate and reliable data, paving the way for future regulatory approvals both in the US and around the world.

We also specialize in ophthalmic pre-clinical and clinical regulatory strategy and guidance with the FDA and international regulatory agencies. We work across all ophthalmic indications, in both drugs and devices, and conduct research in North America, Europe, Asia, and South America.

Our clinical study project management services include:

• Protocol writing
• Site start-up
• Site management
• Vendor management
• Clinical monitoring
• Medical monitoring
• Data management
• Biostatistics
• Medical writing

Our preclinical development services include:

• Study design
• Study execution
• CMC