Oxford BioMedica

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Coordinating Center
Emmes U.S.
Project Status
Active
Project Lifespan
07/31/2010
Objective

The studies under this project are designed to optimize the evaluation of both the ocular and overall safety profile, but include a number of ophthalmic investigations targeted at detection of early indications of bioactivity of the therapeutic interventions.

Population

GEM and StarGen: Males and Females 18 years and older. UshStat: Males and Females 6 years and older.

Phase
I
Centers

Johns Hopkins University, Centre Hospitalier National d’Ophthalmologie des Quinze-Vingts, Oregon Health and Science University

Products
AdvantageEDC
GlobalTrace
Services
Data Analysis and Reporting
Meeting Coordination and Support
Protocol Monitoring
Project Management
Regulatory Affairs
Statistical Leadership and Project Management
Training and Certification
Web-based Data Collection and Reporting Systems
Ophthalmology