ESTERN MEDICAL CRO Life Sciences: A LEADING FORCE IN OPHTHALMOLOGY CLINICAL RESEARCH TRIAL PROJECTS
Explore the forefront of ophthalmic research with ESTERN Medical CRO Life Sciences, the preferred choice for clinical trials in ophthalmic medical devices (implantable, surgical, and diagnostic) and pharmaceuticals. We serve diverse Sponsors, ranging from industry leaders to early and mid-stage and global companies across the US & Latin America.
Diverse Project Portfolio
ESTERN Medical has successfully managed a spectrum of projects, from single-site Phase I and II studies with fewer than 100 subjects, followed for one week, to large Phase III multi-center initiatives involving several hundred subjects. Our project objectives span from assessing the feasibility of clinical development programs to conducting pivotal studies for safety and effectiveness, supporting pre-market US FDA & EMEA approval submissions, and generating data for corporate marketing objectives.
Efficient Management for Ophthalmic Research
Navigating the intricacies of ophthalmic research demands an extensive network of specialists. ESTERN Medical maintains a robust network of research ophthalmologists and Key Opinion Leaders (KOLs) in Latin America, covering cornea, retina, glaucoma, and various ophthalmology diseases. This network, dispersed across the US & Latin America Mexico, Colombia, Peru, Chile, and Argentina in hospitals, clinics, and private practices, facilitates early-phase through pivotal/Phase II & III and post-market studies.
Clinical Trial Expertise in Ophthalmology
Our involvement encompasses regulatory management, clinical site management, monitoring, and medical writing support for surgical and medical therapies. Key areas of expertise include:
- Age-related macular degeneration
- Cataract, including removal and intraocular lens replacement
- Diabetic retinopathy
- Dry eye
- Glaucoma
- Intravitreal hemorrhage
- Macular edema
- Ophthalmic wound healing
- Proliferative retinopathy
- Refractive disorders (myopia, hyperopia, presbyopia)
- Seasonal allergic conjunctivitis
Procedural Familiarity and Program Efficiencies
ESTERN Medical CRO recognizes the unique demands of ophthalmic study design. Our organization is well-versed in the terminology, exams, and instrumentation used in ophthalmology practices. We understand the intricacies of patient recruitment and follow-up, ensuring trials are executed with precision.
Ophthalmic Clinical Program Capabilities
Our capabilities include regulatory strategy consultation, therapy-specific clinical consultation, study feasibility assessments, regulatory submissions, early-phase/safety studies, and product registration studies in the US & Latin America.
Pharmaceutical Products and Medical Devices Expertise
ESTERN Medical CRO’s experience extends to pharmaceutical and medical device projects, including studies related to:
- Drug-eluting implants for Diabetic Macular Edema
- Posterior segment drug delivery systems for persistent macular edema
- Injectable solutions for prevention of recurrence of Proliferative Vitreoretinopathy
- Ocular tolerance of eye drops for mild to moderate dry eye syndrome
- Comparative studies of ophthalmic emulsions and artificial tears for Keratoconjunctivitis Sicca
Ongoing Commitment to Excellence
Choose ESTERN Medical CRO Life Sciences for your ophthalmology clinical projects, benefitting from our proven track record, efficient project execution, and dedicated team committed to advancing research in the field.
