Specialized Expertise in Ophthalmology Clinical Research
Medpace’s expertise in ophthalmology studies and consistent track record of success as a full-service CRO ensures the flexibility to adapt to the unique needs of each ophthalmology trial. Our in-house physicians are board-certified medical doctors that are embedded within the project team. This allows our doctors to be fully-involved throughout the study, providing leadership, consulting with Sponsors, training project teams, and the investigative sites to ensure our operational strategy is firmly aligned with the Sponsor’s scientific and medical objectives.
Our experience with global regulatory authorities, coupled with early planning and collaboration with Sponsors, accelerates the path to approval. Our therapeutically trained teams including clinical trial managers and program coordinators provide knowledgeable training to sites and help mitigate challenges.
Our physicians and professional staff understand the complexities of ophthalmology trials from the perspective of the Sponsor, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. We bring these perspectives to each clinical trial that we conduct.
Advanced Therapy Research in Ophthalmology
With recent and promising advances in ophthalmology gene therapy clinical trials, Medpace’s deep experience in advanced therapy research across multiple therapeutic areas, is beneficial for Sponsors. Our cross-specialty experience is key for managing complex ophthalmology trials. The expertise we provide to other therapeutic areas, where endpoint and sub-studies with ophthalmology may exist, is invaluable. Our expertise and lessons learned provide guidance on the complexities often involved in complex research.
Imaging Core Lab
The Medpace imaging core lab is led by a group of board-certified ophthalmologists including retinal specialists, and PhD scientists with backgrounds in medical physics, imaging, and quantitative image analysis. This experienced group has an in-depth understanding of the various ophthalmic techniques available including many modalities and measurement criterion for critical imaging endpoints required for evaluations and provide reliable and reproducible interpretations of ocular images.
The imaging core lab has extensive global experience with trial design, data interpretation and analysis, global study management, and regulatory strategy consultation. Further, the imaging group has long-standing relationships and collaboration with central reading centers with various modalities of ophthalmic imaging. The ability to streamline imaging and data management services into the overall clinical trial provides seamless integration and efficiency while lessening the burden on sites and patients.
Medpace’s central laboratories are experienced in clinical research from discovery and proof of concept through large, long-term global trials. Located in the US, Belgium, China, and Singapore, all are wholly-owned and purpose-built with state-of-the-art infrastructure. Each location has the same testing instrumentation, follow global operating procedures, and utilize a single laboratory information system, ensuring perfect harmonization of global data.
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