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Information for Study Sponsors

Information for
Study Sponsors

The Eye Research Foundation has been successfully conducting clinical trials since 1998.  Founded by Linda Wirta and Dr. Wirta, our mission is to provide a highly responsive clinical site where the latest in eye and cosmetic treatments can be tested with the highest standards of compliance and accuracy.

Our center is staffed by two physicians, and a clinical staff that includes a clinical manager (Linda Wirta) and six certified clinical coordinators who are double-certified as COA’s (Certified Ophthalmic Assistants).  In addition, ancillary staff of Clinical Coordinator assistants, phlebotomists, and clerical/data-entry personnel are available.  We have extensive experience in phase I-IV clinical trials, and have capacity for overnight Phase I and PK studies on site.  Our areas of expertise include glaucoma/ocular hypertension, dry eye, presbyopia, blepharitis, post-cataract, cosmetic indications, healthy-normal studies, Japanese bridging studies, and other ophthalmic products.  We specialize in single-site, Phase I, ophthalmology studies.

9 bed capacity

On-site overnight capabilities – 9 bed capacity

Off-site ASC Access

Off-site ASC access for aqueous humor sampling studies, and our surgical procedure projects

Phase I-IV

Phase I-IV study experience

Fully Engaged PI

Fully engaged PI (Dr. Wirta) and study center director (Linda Wirta)

Phlebotomists

On site phlebotomists

Latest Ophthalmology Equipment

Cirrus OCT, Humphrey VF, Konan endothelial cell camera, DGH ultrasound, Haag-Streit slit lamps, Goldman applanation tonometry, Atlas topography, etc.

Drug Storage

Temperature controlled, monitored and secure drug storage (room temperature, refrigerated, -20, -70)

Blood Sampling

Serial PK blood sampling

Operating Microscope

On-site operating microscope for implant projects

100% Track Record

Track record of 100% of the time meeting or exceeding enrollment targets

CCRC's

Six certified clinical coordinators

Monitoring Rooms

Spacious monitoring rooms/capability for multiple simultaneous monitors

ECG Machines

Two ECG machines

FDA Audit Experience

FDA audit experience, excellent track record with audit performance for pivotal trials