Ophthalmic Clinical Research

Experienced CRO for Ophthalmology Clinical Research

Our core expertise at iuvo has been as CRO of choice for hundreds of ophthalmic device (implantable, surgical and diagnostic), biotechnology and pharmaceutical clinical research projects. We have supported clients ranging from industry leaders to early-stage companies, serial entrepreneurs and private practitioners.

We have managed hundreds of ophthalmic clinical research projects ranging from single-site studies involving less than 100 subjects followed for one week to large, multi-center projects involving hundreds of subject eyes followed over the course of several years.

iuvo maintains an extensive network of research ophthalmologists and opinion leaders across several ophthalmic specialties, including: cornea, retina, glaucoma and general ophthalmology. These resources help provide our clients with expert guidance and advice on ophthalmic clinical program development. In addition, our network of study sites, located throughout the U.S. and Canada in hospitals, clinics and private practices, can provide early phase through pivotal/Phase III and post-market studies.

Within ophthalmology, our involvement typically includes overall project management, protocol development, 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

At iuvo, we understand that ophthalmic study design and implementation requirements may be quite different from studies in other medical specialties. Our staff is keenly 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 quickly develop project plans and assemble skilled, expert project teams to partner with our clients to ensure successful study outcomes. And because of our depth of experience – specifically in ophthalmology – trials tend to have better patient recruitment results and to run on-time and within budget.

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 surgery 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)

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