Accelerating Complex Ophthalmology Clinical Trials with Specialized Expertise
With continuing innovations and advances in ophthalmology drug development, ophthalmology clinical trials are becoming increasingly complex. These trials require a clinical research organization (CRO) partner with innovative patient enrollment capabilities, strategic study design and execution, and cell, gene and RNA based therapy experience.
Accelerate your path to approval with guidance from our team of ophthalmology-focused medical, operational, and regulatory experts. Our extensive experience, world-class expertise, and consistent track record of success ensure the flexibility to adapt to the unique needs of each ophthalmology trial, overcome complex challenges, and keep trials on time and on budget.
Making the Complex Seamless® in Global Ophthalmology Clinical Trials
Drive the successful execution of ophthalmology clinical trials through a partner with strong communication, coupled with early planning and experience collaborating with global regulatory authorities. Sponsors from emerging biotechs to global pharmaceutical companies have trusted Medpace for over 30 years to lead their ophthalmology development across a wide range of indications, including but not limited to Age-Related Macular Degeneration, Inherited Retinal Disease, Cataracts, Glaucoma, Cornea, Diabetic Macular Edema, and Natural History Studies.
Ophthalmology CRO Capabilities
Our medical, operations, and regulatory 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 to help keep trials running efficiently and according to protocol.
- Providing comprehensive support via our dedicated global regulatory submissions and global regulatory affairs teams
- Extensive experience partnering with the Sponsor’s choice of vendor for ophthalmology imaging to support each trial’s unique needs
- CAP-accredited central laboratory services for safety testing, PK/PD, biomarkers, and genomic testing; ensure the perfect harmonization of global data through wholly-owned and purpose-built laboratories with state-of-the-art infrastructure
Gene Therapy Research in Ophthalmology Clinical Trials
Executing ophthalmology gene therapy clinical trials is complex due to challenges including study procedures and assessments, site training, and sample storage. Our expertise and lessons learned in gene therapy ophthalmology clinical trials allow us to provide guidance to help Sponsors successfully navigate common complexities. Ensure successful patient recruitment and retention, effective investigator training, and reduce trial risks through our in-depth experience in gene therapy research across multiple therapeutic areas with both subretinal and intravitreal delivery.
Proactive Patient Recruitment & Retention
The success of clinical trials is wholly dependent on the success of sites and the engagement of patients. Our proprietary IntelliPACE® feasibility strategy is informed by a multitude of internal and external sources to provide a highly customized, informed recruitment strategy for each study. Accelerate patient enrollment with strategic guidance from our dedicated, in-house patient recruitment and retention teams who are experienced in recruiting complex patient populations including pediatrics, geriatrics, and rare ocular diseases.
Strong, Long-Term Relationships
Medpace has built strong, long-term relationships with investigators, experienced sites, networks, and key opinion leaders specializing in ophthalmologic indications. The long-standing relationships combined with our experience help facilitate strategic site selection, start-up, and recruitment efforts translating into the successful and timely recruitment, conduct, and delivery of a study.
Ophthalmology Clinical Trial Experts
Our cross-functional, therapeutically trained teams include ophthalmology-specialized clinical trial managers and program coordinators that provide knowledgeable training to sites and operational leadership. In-house, board-certified ophthalmologists and gene therapy specialists add an additional layer of medical and scientific expertise and are embedded within the project team throughout the lifecycle of your trial. They provide leadership, consulting with Sponsors, along with training project teams and investigative sites to ensure our operational strategy is firmly aligned with your scientific and medical objectives.
“I see my role as an extension of the Sponsor and am available to guide and support them, especially for some smaller biotechs that often don’t have internal ophthalmologists on their teams.”Zaiba Malik, MD
Medical Director, Medpace