For Sponsors and CROs

• Motivated by deep respect for the scientific value of clinical research and the ethical management of our clinical patients.
• Fully developed Standard Operating Procedures including QA audit tools and procedures for FDA compliance
• Ongoing review of clinical trial regulations and system adaptation
• Prompt turn-around of regulatory documents, contracts, and budgets 
• Strong subject recruitment plans as demonstrated by solid enrollment results
• Accurate trial performance in a timely manner with data integrity

• Our highly qualified research team has extensive experience in clinical research with exemplary community reputation.    
• Our Investigators have a total of 25 years of clinical research experience.
• Optometrist, Ophthalmologists with retina and cornea specializations.
• Our clinical staff has over 60 years of cumulative clinical research experience, including pharmaceutical R&D drug development, CRO, and audit experience. Certified Phlebotomist on staff.
• We have worked with large and small pharmaceutical companies and with university research centers, as well as many CROs. Our success begins with the selection of projects. 
• We will not commit to a study unless we feel certain we can successfully meet or exceed enrollment.
• We pride ourselves in having been a top enroller for all our completed clinical trials.
• All our investigators and clinical staff are extensively knowledgeable, trained and experienced with FDA requirements, GCP, and ICH guidelines.

We conduct ophthalmic research studies for pediatrics, adolescents, adults, and geriatrics. Areas of research include glaucoma/ocular hypertension, adenoviral, bacterial, and allergic conjunctivitis, blepharitis, keratoconjunctivitis sicca (dry eye),  meibomian gland dysfunction (MGD) , myopia control, presbyopia, astigmatism, and devices such as contact lenses. 

Our research population includes rural, urban and suburban patients ranging from infants to the elderly. The greater Raleigh area also offers a diverse ethnic population. We recognize the success of every clinical trial hinges on the success of the recruiting strategies for identifying qualified and compliant patients. We have access to thousands of patient records allowing rapid retrieval of patient data based on diagnosis or other inclusion/exclusion criteria. We also have a referral network of optometrist and ophthalmologists, as well as sub- investigators who refer qualified patients.

Lisa Faison, MPH, Sr. Clinical Research Associate, Lexitas Pharmaceuticals:

“I am a senior clinical research associate with over 15 years of monitoring experience. For the last year, I have had the pleasure to work as a monitor for Oculus Research on a dry eye study. In working with the site, they have shown excellent documentation practices, adherence to the protocol and timely responses to all inquiries. The site staff are well trained and very organized. In addition, Dr. Aune has shown her direct oversight of the study with her progress notes and personally conducting most of the study assessments. The site exceeded their enrollment goal and provided the study with quality subjects and data. I highly recommend the Oculus Research group for future ophthalmology research studies.”