Ophthalmology Studies

PPD has developed a specialized clinical operations and therapeutic focus on ophthalmology studies with experienced project teams dedicated to all ophthalmic programs. Our ophthalmology staff has extensive expertise, global experience in multiple therapeutic areas and regulatory expertise for multinational submission and expeditious agency review. In addition, PPD has an international network of experienced investigative sites for efficient subject enrollment.

Ophthalmology services include:

International program design and management
Clinical project management
Subject and investigator site recruitment
Clinical monitoring
Data management
Statistical analysis
Medical writing
Dossier preparation and submission

Global Clinical Trial Experience

PPD has expertise in ophthalmic clinical research in the following areas:

Conjunctivitis
Glaucoma
Keratitis
Macular edema
Age-related mcular degeneration (AMD) and associated syndromes
Viral- and chlamydiae-related diseases, such as cytomegalovirus retinitis
Dry eye
Lens opacification

Innovative Technologies

PPD has experience with therapeutic-specific vendors such as:

Reading centers

Fluorescin angiography (digital or film)
Fundus photography
OCT
Endothelial cell counts
Certification centers (Wilmer, EMMES)

Chart vendors

ETDRS
Snellen
LEA
Pelli-Robson

Electronic Data Capture

PPD has experience with many electronic data capture technologies, such as those from:

Oracle®
DATATRAK
PhaseForward
CB Technologies/ViPs
eTrials
IVR systems

Regulatory Expertise

PPD understands international regulatory requirements and is experienced in simultaneous submissions in multiple countries and languages. PPD regulatory affairs professionals position your documents for expeditious review.