Study Protocol Development

Our Services

OIRRC delivers end-to-end support for ophthalmic clinical trials, including protocol development, site management, imaging, eligibility review, data analysis, and regulatory compliance. Our team ensures high-quality data, fast turnaround, and seamless collaboration from start to finish.

Study Protocol Development

We collaborate with investigators and sponsors to develop study protocols that meet scientific objectives while adhering to regulatory requirements and ethical standards. Our team ensures that protocols are meticulously designed to optimize study outcomes and minimize risks to participants.

Site Selection and Management

We assist in identifying and selecting clinical trial sites with the expertise and infrastructure necessary to conduct eye care research effectively. Our team provides ongoing support to study sites, including training, monitoring, and troubleshooting, to ensure protocol adherence and data quality.

Certification

OIRRC provides certification services for photographers and equipment. We ensure daily data capture by qualified staff and devices, providing clear and consistent results. Our goal is to deliver the most complete data set, enabling our clients and their statistics teams to achieve optimal analytics. Benefit from our expedited services with quick turnaround times.

Eligibility

We offer comprehensive eligibility services to ensure inclusion/exclusion criteria are met per protocol for each subject. Our experienced team can provide these assessments in expedited fashion, even while subjects are on-site for real-time randomization, if necessary.

Image Acquisition and Analysis

We develop comprehensive imaging manuals for a wide range of ophthalmic devices and modalities, including anterior and posterior optical coherence tomography, color fundus photography, autofluorescence, visual fields, microperimetry, anterior segment photography, electroretinography, wide angle imaging, specular microscopy, slit lamp photography, adaptive optics, and fluorescein angiography. Our team provides expert image analysis using standard and/or custom protocols, enhanced by in-house AI capabilities. These tools support the evaluation of novel endpoints and enable the delivery of precise, timely, and insight-driven imaging assessments to support clinical research objectives.

See capabilities of modalities from the various devices available on the market below.

Data Collection and Management

We implement robust data collection and management systems to capture, store, and analyze study data accurately and securely. Our team utilizes electronic data capture (EDC) platforms and standardized data collection forms to streamline data entry and ensure data integrity throughout the study duration.

Quality Control

We adhere to rigorous quality control measures to ensure the reliability and accuracy of imaging data generated during clinical trials. Our comprehensive Quality Control (QC) processes include equipment calibration, image standardization, and meticulous review of image quality to maintain the highest standards of data integrity. Again, benefit from our expedited services with quick turnaround times.

Regulatory Compliance

We are committed to maintaining compliance with regulatory requirements governing clinical trials. Our team stays up-to-date with regulatory guidelines and ensures that imaging procedures and data management practices adhere to regulatory standards set forth by agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency). In addition, we maintain full compliance with HIPAA, GDPR, and SOC 2 standards to ensure the highest levels of data security, privacy, and integrity.

Statistical Analysis Support

We provide tailored statistical support to help uncover insights into clinical endpoints and treatment effects. Our team ensures that relevant biomarkers are thoroughly evaluated from multiple analytical perspectives, enabling a deeper understanding of study outcomes and enhancing the value of collected data.

Collaborative Partnerships

We view our clients as partners and collaborate closely with them throughout the duration of the clinical trial. Our project managers provide personalized support and facilitate seamless communication to ensure that imaging objectives are met efficiently and effectively. In addition, we maintain strong partnerships across the industry, including with leading imaging manufacturers and vendors, allowing us to stay aligned with evolving technologies and best practices. See list of vendors and manufacturers we work with below.

Our Services