Clinical Site Monitoring

Our CRAs are strategically located around the globe to provide local monitoring and the confidence that studies are being conducted to the highest standards.

Clinical Trial Monitoring

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:

  • Are always in compliance with International Council for Harmonization (ICH) and current Good Clinical Practices (cGCP)
  • Have source documentation templates that adhere to the highest standards of quality
  • Use processes and procedures for data entry that comply with clinical monitoring plans
  • Have Standard Operating Procedures (SOPs) to provide impeccable consistency, regardless of site location
  • Are always ready for inspections and audits and that the maintenance of investigator site files complies with industry expectations and regulatory standards
  • Have processes that allow for the real-time identification of adverse events (AEs) and serious adverse events (SAEs)

Trust in the expertise of ORA CRAs

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

Risk Based Monitoring

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.

Ora’s RBM Program:

Efficient processes determined by risk assessment and mitigation

  • Quality by Design (QbD)
  • Risk Assessment Categorization Tools (RACT)
  • Risk Log
  • Integrated Quality and Risk Management Plan (IRBMP)
  • Critical Data and Processes Identification
  • Risk Management Programs (RMP)
  • Key Risk Indicators
  • Data Quality Analytics
  • Remote Data Review
  • Safety Data Review
  • Source Documentation Verification
  • Site Quality Verification
  • Remote Contacts
  • Off-site Monitoring Activities

Risk Based Management (RBM): Remarque Systems

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.

System capabilities

  • Signal Driven SDV™ uses triggers established prior to study start, combined with machine-learning capabilities, to make better monitoring decisions
  • Built-in risk assessment and mitigation module
  • System-agnostic data intake can consume data from any source, in any format, without the requirements of a data warehouse
  • Role-based remote monitoring supporting roles for managing site, patient, and protocol level risks
  • Purpose-built integrated workflow solutions designed to scale as needed
  • Intuitive, interactive, role-driven visualizations with complete drill-down capabilities
  • Robust workflow functionality built into every role to easily convert findings to trackable actions
  • Knowledge engine that uses machine learning, combined with classical statistical models, to predict, detect, analyze, and manage risk

Medical Monitoring Services

 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.

  • Ongoing review of all adverse event (AE) listings
  • Maintaining awareness of any AE/safety issues in other ongoing clinical trials with similar products
  • Responding to questions about patient eligibility
  • Reviewing AEs and discusses any relationship or abnormal findings
  • Reviewing coding reports for accuracy
  • Overseeing dose escalation stopping rules and dose-limiting toxicity (DLTs)
  • Transparent serious adverse event (SAE) reporting and follow-up with investigators
  • Investigation of suspected unexpected serious adverse reactions (SUSARs)
  • Safety Management Plans with standard flow chart for SAE communication
  • Reviewing safety reports
  • Reviewing final clinical study reports

Pharmacovigilance

If you need safety reporting for your approved product, we offer pharmacovigilance services in association with our partner company, SDC.