Company Profile
ORA Clinical Research and Development is a full service contract research organization based in North Andover, MA, which was founded by Dr. Mark B. Abelson, MD, and is committed to the research and development of medical devices and drugs for the ophthalmic and topical pharmaceutical industry. Specializing in the field of ophthalmology, ORA has gathered the top professionals and researchers in this field over the past 30 years. Combining a unique, dynamic, and dedicated group of research professionals known for their ability to produce quality results in a timely and cost effective manner, ORA has become a leader in its field.
Dr. Abelson and ORA have developed an internationally renowned reputation for their core expertise in clinical-regulatory strategy, clinical model, study design, and execution specifically for ophthalmic products. ORA has extensive experience in the areas of allergy, dry eye, glaucoma, and anti-infective and anti-inflammatory ophthalmic treatments. ORA has since taken its knowledge and expertise into similar fields, which has grown the business exponentially. Through extensive research in the areas of allergy and dry eye, ORA has been able to identify similarities in the function of the eye, skin, and nose. This research has allowed ORA to expand its areas of research while keeping the level of knowledge and expertise at the same level study sponsors expect.
While most CROs offer a multitude of research fields, ORA continues to stay a leader within specific fields so that it can offer its clients a level of expertise that is unmatched. With a core expertise in clinical regulatory strategy and model development, the research groups at ORA are constantly building and improving upon current methods and models with a high level of expertise and creativity. The controlled clinical models developed by ORA for evaluating anti-allergics, the Conjunctival Allergen Challenge Model (CAC), and for evaluating dry eye, the Controlled Adverse Environment (CAE), are the standard accepted models in the field, and are recognized by the US Food and Drug Administration, Europe, and Japan for the evaluation of new drugs. The ability to develop and implement these new methods and models is directly attributed to the fact that research does not end at FDA approval. Through marketing comparison studies and continuous research on research, ORA is constantly improving upon methods and models that are already considered the benchmark.
Having worked with some of the largest pharmaceutical companies in the world, ORA has provided research and development for a majority of ophthalmic products. ORA has also aided many smaller/startup companies, which do not have the resources of a large corporation, develop their products with the same timelines and level of service that large clients receive. ORA’s ability to act as a virtual R&D unit for both startup and established clients through its knowledge of the market and relationships with manufacturing facilities allows for a complete start to finish offering, which includes assisting clients in business planning, pipeline development, product marketing, licensing, and venture capital interfacing.
ORA is comprised of a staff of over 50 fulltime research professionals. Each project draws from a cross functional team with specific expertise in clinical and regulatory design, marketing, medical writing, and business development.