OUR SERVICES
Core Imaging Lab Support for Clinical Trials
At OIRRC, we specialize in providing end-to-end imaging lab and research support for ocular health clinical trials. Partnering with pharmaceutical companies, CROs, and academic institutions, we ensure the highest quality data collection and analysis to drive successful trial outcomes.
- 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. Additionally, we are capable of completing certifications within a three-day turnaround time.
- Imaging Protocol Development: We work hand-in-hand with trial sponsors to develop imaging protocols tailored to the specific needs of each clinical trial. Our expertise ensures standardized and optimized imaging for accurate and consistent data collection.
- 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: Using state-of-the-art imaging technology, we ensure precise and detailed image acquisition across various 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 skilled technicians and image analysts meticulously process and analyze imaging data to provide valuable insights into disease progression and treatment efficacy. We develop custom algorithms to assess novel endpoints, enhancing our ability to deliver comprehensive and tailored analytical solutions. With industry-leading turnaround times, we can confirm the status of subjects at any time point you see fit.
- 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 and Assurance: We adhere to rigorous quality control and assurance measures to ensure the reliability and accuracy of imaging data generated during clinical trials. Our comprehensive Quality Control (QC)/Quality Assurance (QA) 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: OIRRC is 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).
- Collaborative Partnership: 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.