Company Profile
For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 30 NDA approvals within the category. In fact, we have been directly involved in the development of over one-third of the world’s currently marketed ophthalmic pharmaceutical products.
Ora stands apart from all other research groups in that we have conducted over 1,200 clinical trials and consulting projects within the ophthalmology category. This deep knowledge and expertise has made Ora the preferred ophthalmic drug development partner for many of the top ophthalmic pharmaceutical companies in the world. Our unwavering mission is to apply our core scientific knowledge, regulatory expertise, and clinical excellence to give every drug its best chance to succeed.
Ora functions as a virtual R&D unit that has helped countless pharmaceutical companies develop new ophthalmic products from molecule to marketplace. Over the past three decades, we have provided turnkey operations for ophthalmic start-ups, mid-sized companies, publicly traded companies, and large multinationals.
Our reputation has been built upon a solid foundation of scientific rigor and research excellence. Since our founding, we have developed a series of proprietary clinical models that have consistently generated accurate and reliable data to support regulatory approvals, both in the US and around the world.
We design, execute, and innovate the most efficient ophthalmic clinical development programs in the industry. We dedicate considerable resources towards internal research and development to advance ophthalmic clinical research design, including model innovation and evolution, endpoint development and evaluation, and clinical trial processes and management strategies.
We have earned a reputation for pioneering new clinical pathways, developing and applying new technology and creating significant value for our clients. We have extensive drug development experience in the areas of dry eye, allergy, glaucoma, anti-infective, anti-inflammatory and retinal ophthalmic treatments. Over the past 5 years, we have also leveraged our scientific and management expertise into the areas of dermatology and otolaryngology.
Our team of over 100 full-time, ophthalmic-focused research professionals provides turnkey development services that include: business planning, clinical development planning, pre-clinical screening, toxicology management, CMC consulting, clinical trial performance, including site management, monitoring, data management and analysis through SDC (our sister company), overall clinical-regulatory strategy, regulatory filings, and marketing support. We also maintain strategic relationships with toxicology laboratories, formulators, manufacturing facilities, and other collaborators and consultants.
Our operational excellence, aggressive project management and close involvement of our senior staff ensure that we are able to deliver accurate results, on time and within budget for every study that we lead.