Advances in cell and gene therapies and biologics, supported by specialized ophthalmology CROs, are bringing hope to the millions worldwide who are afflicted by ophthalmic diseases that limit vision and can cause blindness. Innovators in drug development are exploring novel therapies to treat these diseases, and the number of ophthalmology clinical trials involving ocular disorders are expanding rapidly. These studies offer new opportunities for treatment to those willing and able to participate. Understanding how to recruit and engage them and then, crucially, incorporating appropriate participation considerations for those with vision impairment, are fundamental to Parexel’s patient-focused approach. Easing the patient burden through concierge services, caregiver support, and accessible informational materials, for example, are essential elements of our strategy.
Parexel has long been a leader in development of cell and gene therapies for retinal disease
We maintain strong partnerships with patient advocacy groups, including the Foundation Fighting Blindness, which consulted with our team in establishing Parexel’s Inherited Retinal Disease Patient Advisory Council. We have learned from patients that many optometrists and ophthalmologists are unfamiliar with these diseases and unaware of clinical trials. One of our primary objectives is to align with key opinion leaders (KOLs) to help amplify the message and thereby ensure that people diagnosed with a retinal disease have a clear next step. KOLs in our network include ophthalmic specialists from some of the world’s preeminent research institutes and medical centers.
Parexel’s commitment to ophthalmology and clinical research for eye diseases has attracted an outstanding team of 10 board-certified ophthalmologists, as well as an alliance of investigators and KOLs, who are devoted to finding treatments for these debilitating conditions. They work in collaboration with our centers of excellence in cell and gene therapies and rare disease, along with biostatisticians, clinical operations and regulatory experts, and site alliance teams.
Our experience spans every phase of the development lifecycle, encompassing novel treatments targeting the more common indications such as wet age-related macular degeneration (wet AMD), geographic atrophy (GA), diabetic macular edema (DME), diabetic retinopathy (DR), retinal vein occlusion (RVO), retinopathy of prematurity (ROP); rare inherited diseases such as retinitis pigmentosa (RP), achromatopsia, cone rod dystrophies (CRD); orbit and inflammatory conditions such as thyroid eye disease and uveitis; anterior segment conditions such as keratitis, corneal neovascularization, and glaucoma. Additionally, our expertise in gene therapy for ocular diseases positions us at the forefront of developing cutting-edge treatments aimed at restoring vision and preventing disease progression.
In the past five years, we have conducted 138 ophthalmology projects, including 63 full-service clinical projects, 42 full clinical trials for retinal disease, with more than 9,800 enrolled patients across over 730 sites in more than 55 countries globally. Parexel has supported the clinical development of five retina products that have achieved market approvals in four different indications, including one for a rare inherited disease.
Global leadership and expertise
Our global ophthalmology team is spearheaded by Dr. Bharti Arya, a highly experienced board-certified ophthalmologist with over 12 years in academic medical practice and a proven track record of supporting regulatory approvals for retinal conditions. Her team includes 9 board-certified ophthalmologists across the globe, providing a comprehensive and diverse perspective on ophthalmology research, who are supported by a large team of ophthalmology-experienced clinical operations staff and strategic feasibility and solutions consultants. As an ophthalmology CRO, we are dedicated to advancing clinical research and delivering innovative solutions for ophthalmic drug development.
Working with us
At Parexel our core value starts with Patients First. We know a successful trial depends on mapping the RIGHT studies to the RIGHT sites to ensure the RIGHT patients are recruited. Parexel’s Site Alliance program enables us to predict the successful delivery of our clinical trials, and ultimately getting the RIGHT treatments to patients who need them most.
Through our Site Alliance relationships, we have achieved:
- Early feedback on study designs
- In-depth knowledge of sites’ experience, facilities, resources and patient populations
- Open and transparent communications
- Efficient budget/contract negotiations and payments
If you are interested in conducting Ophthalmology trials with Parexel, please create your center/investigator profile utilizing the following link: Parexel Center / Investigator Registration
Our experts
Frequently asked questions
An ophthalmology CRO is a specialized company that provides clinical research services specifically focused on eye-related studies and trials. These organizations offer expertise in designing, managing, and conducting clinical trials for ophthalmic drugs, devices, and treatments. They work closely with pharmaceutical companies, biotechnology firms, and medical device manufacturers to develop and test new therapies for various eye conditions such as glaucoma, macular degeneration, diabetic retinopathy, and other vision-related disorders.
An ophthalmology CRO supports eye care research by providing specialized expertise and resources throughout the entire clinical trial process. These organizations offer comprehensive services that include protocol development, site selection and management, patient recruitment, data management, and regulatory compliance. They leverage their in-depth knowledge of ophthalmic conditions and treatments to design studies that effectively evaluate new therapies, drugs, or medical devices. Additionally, ophthalmology CROs often have access to advanced imaging technologies and diagnostic equipment specific to eye care, ensuring accurate and reliable data collection.
Furthermore, these CROs play a crucial role in accelerating the development of new eye care treatments by streamlining the research process. They maintain extensive networks of ophthalmologists, research centers, and patient populations, which allows for faster and more efficient trial execution. Ophthalmology CROs also stay up-to-date with the latest regulatory requirements and industry standards, helping sponsors navigate complex approval processes. By managing the logistical and operational aspects of clinical trials, these organizations enable researchers and pharmaceutical companies to focus on the scientific aspects of their studies, ultimately contributing to advancements in eye care and potentially improving outcomes for patients with various ocular conditions.
Ophthalmology CROs typically focus on a wide range of ophthalmic conditions that affect different parts of the eye and visual system. Some of the most common areas of research include wet age-related macular degeneration (wet AMD), geographic atrophy (GA), diabetic macular edema (DME), diabetic retinopathy (DR), retinal vein occlusion (RVO), retinopathy of prematurity (ROP); rare inherited diseases such as retinitis pigmentosa (RP), achromatopsia, cone rod dystrophies (CRD); orbit and inflammatory conditions such as thyroid eye disease and uveitis; anterior segment conditions such as keratitis, corneal neovascularization, and glaucoma. They may be involved in research on less common but serious conditions like uveitis, ocular tumors, and various inherited retinal diseases.
Beyond these specific conditions, ophthalmology CROs often engage in studies related to novel drug delivery systems for eye medications, gene therapies for inherited eye disorders, and innovative surgical techniques. They may also focus on emerging areas such as the use of artificial intelligence in diagnosing eye conditions, the development of advanced intraocular lenses, and the creation of new imaging technologies for early detection of eye diseases. The scope of their work can extend to pediatric ophthalmology, neuro-ophthalmology, and the ocular manifestations of systemic diseases, reflecting the diverse and complex nature of eye care research.
An ophthalmology CRO ensures regulatory compliance in clinical trials through a multifaceted approach. They start by maintaining a thorough understanding of current regulatory requirements from agencies like the FDA, EMA, and other relevant international bodies. The CRO implements robust quality management systems and standard operating procedures (SOPs) that align with Good Clinical Practice (GCP) guidelines. They provide comprehensive training to staff and investigators on regulatory requirements and ethical conduct. Throughout the trial, the CRO conducts regular internal audits and monitors trial sites to ensure adherence to the protocol and regulatory standards. They meticulously manage and document all trial-related activities, maintaining detailed records for potential regulatory inspections. The CRO also stays vigilant about adverse event reporting and ensures timely submission of required documents to regulatory authorities. By leveraging their expertise in ophthalmic research and regulatory affairs, they help sponsors navigate complex regulatory pathways, prepare for regulatory submissions, and respond effectively to any queries from regulatory bodies, thereby safeguarding the integrity and compliance of the clinical trial.