Our CRAs are strategically located around the globe to provide local monitoring and the confidence that studies are being conducted to the highest standards.
Ora’s global Clinical Research Associates (CRAs) are seasoned professionals dedicated to ensuring the quality and success of your trial. Our clinical monitoring team has extensive device and investigational product experience across all phases of ophthalmology clinical development. We offer traditional monitoring or risk based monitoring (RBM) approaches. Our experienced team conducts both on-site and remote monitoring visits.
Our CRAs build personable relationships with your sites, working with principal investigators and site staff from study start-up to close-out. We work with our sites to ensure that they:
Average of 5 years of monitoring experience
Minimum of 2 years ophthalmology experience
Average of 5.5 years of ophthalmology experience
70% of the CRAs have been with Ora for more than 2 years
Ora’s risk based monitoring (RBM) process helps assess, control, communicate, and review the quality risks to drug products across the product lifecycle. Ora offers an RBM monitoring methodology for all trials focused on patient safety and data quality. Our RBM approach is compliant with ICH-GCP guidelines and regulatory recommendations. Our approach has the potential to reduce costly site errors and optimize trial efficiency.
Efficient processes determined by risk assessment and mitigation
RBM is a comprehensive software application for designing, deploying, and managing risk based monitoring trials. The system uses advanced visualizations, analytics, and machine learning for robust risk prediction, detection, analysis, and management. Ora uses Remarque System’s SaaS Platform for the design, deployment and management of RBM clinical trials.
Ora’s medical monitors provide safety oversight and strategic clinical guidance for all anterior and posterior segment indications – from topical through complex routes of administration, such as sub-retinal injections.
Our team of in-house ophthalmologists bring more than a decade of academic and big pharma experience to their roles as medical monitors for every clinical trial, where patient safety is their primary responsibility. Medical monitors are available 24/7 to respond to any safety-related questions.
If you need safety reporting for your approved product, we offer pharmacovigilance services in association with our partner company, SDC.