PMI has been the CRO of choice for more than a hundred ophthalmic device (implantable, surgical and diagnostic), biotechnology and pharmaceutical clinical research projects for clients ranging from industry leaders to early-stage companies and private practitioners. The projects we have managed range from single site studies involving less than 100 subjects followed for one week to large, multi-center projects involving several hundred subject eyes followed for several years. The project objectives also vary – from assessing the feasibility of clinical development programs to performing the pivotal study of safety and effectiveness in support of a pre-market FDA approval submission to providing data that can be used to support corporate marketing objectives.

Efficient Management for Ophthalmic Research Projects
We maintain an extensive network of research ophthalmologists and opinion leaders who are specialists in cornea, retina, glaucoma and general ophthalmology. These resources provide expert guidance and advice on ophthalmic clinical program development. Our network of study sites, located throughout the U.S. and Canada, is hospital-, clinic- and private practice-based and can provide early phase through pivotal/Phase III and post-market studies. Our involvement typically includes overall project management, clinical site management and monitoring, data management, biostatistics, and medical writing support for surgical and medical therapies associated with:

• Age-related macular degeneration
• Cataract, including removal and intraocular lens replacement
• Diabetic retinopathy
• Dry eye
• Glaucoma
• Intravitreal hemorrhage
• Macular edema
• Ophthalmic wound healing
• Proliferative retinopathy
• Refractive disorders, including myopia, hyperopia and presbyopia
• Seasonal allergic conjunctivitis

Procedural Familiarity and Program Efficiencies
At PMI, we understand that ophthalmic study design and implementation requirements may be quite different from studies in other medical specialties. Our staff is familiar with the terminology, exams and instrumentation used in ophthalmology practices, and, just as important, we are aware of the nuances associated with ophthalmic patient recruitment and follow-up. Our ISO-certified systems include plans, procedures and templates that can be readily customized for ophthalmic projects. These assets allow us to rapidly develop comprehensive project plans and quickly assemble skilled, highly-rated project teams to partner with our clients for optimal success. And because of our depth of experience, trials tend to have better patient recruitment results and to run on-time and within budget.

Our ophthalmic clinical program capabilities include:

• Regulatory strategy consultation: Helping clients understand and manage regulatory procedures and requirements to facilitate achievement of product approval objectives
• Pre-clinical drug formulation and testing: Providing innovative technology and techniques in pre-clinical ocular formulation of test substances for administration in animals
• Ophthalmic therapy-specific clinical consultation: supplying specialty-specific expertise to facilitate the development or implementation of study protocols
• Primary and secondary market research: Providing accurate and timely information regarding the ophthalmic surgical marketplace
• Study feasibility assessments (North America, Europe and India): Understanding the issues that may affect study performance (appropriate study sites, patient recruitment, etc.)
• Regulatory submissions (North America, Europe and India): – IDE, IND, 510(k), PMA, NDA, country-specific (non-US) product approval dossiers
• Early phase/safety studies (North America, Europe and India)
• Product registration studies (North America, Europe and India)
• Ophthalmic exam training and certification: Visual acuity and refraction certifications, staining techniques, tear break-up time assessment, etc.
• Quality system implementation: Understanding and implementing methods and controls for product design, manufacture, packaging and labeling
• Economic strategy and reimbursement: Consulting in the area of Medicare/private pay insurance reimbursement as well value-based technology and strategic market positioning
• Product distribution (U.S. only)

For more details regarding our clinical expertise, please review our Ophthalmology Project Summary (PDF) or Contact Us to discuss your specific project.