Monitoring

Ora’s globally based 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 in all ophthalmology clinical development phases.

What We Do:

Our CRAs build personable relationships with your sites, working with principal investigators and site staff from study start-up to close-out in verifying:

  • Compliance with International Council for Harmonization (ICH) and current Good Clinical Practices (cGCP), along with any other applicable domestic or international regulatory requirements
  • Quality and content of source documentation and data entry
    site processes and procedures along with adherence to Standard Operating Procedures (SOPs) and study protocols
  • Appropriate documentation and root-cause analysis of issues and concerns
  • Site audit readiness and maintenance of investigator site files
  • Investigational product records, compliance and accountability (masked and unmasked monitors)
  • Identification of adverse events (AEs) and serious AEs (SAEs)

We offer a flexible team capable of traditional monitoring or risk-based Quality Risk Management monitoring approaches.  Our team is also capable of conducting both on-site and remote monitoring visits.

About our team:

  • Minimum of 5 years of monitoring experience
  • Average of 5.5 years of ophthalmology experience.
  • 70% of the CRAs have been with Ora for > 2 years

Ora’s Monitoring team provides you with the confidence that your studies are executed to the highest standards, both in terms of the excellence of the dataset and the protection of subject safety.

Quality Risk Management

We offer a quality risk management (QRM) monitoring methodology for all trials with a focus on subject safety and data quality through efficient processes determined by risk assessment and mitigation.  Our QRM program is compliant with ICH GCP guidelines and the recommendations of regulatory authorities. Our program has the potential to reduce costly site errors and optimize the efficiency of your trial execution.

Ora’s RBM program consists of 4 core components:

1. Risk Assessment & Management

  • Quality by Design (QbD)
  • Risk Assessment Categorization Tools (RACT)
  • Risk Log
  • Integrated Quality and Risk Management Plan (IQRMP)
  • Critical Data and Processes Identification
  • Risk Management Programs (RMP)

2. Statistical Data Analysis

  • Key Risk Indicators
  • Data Quality Analytics

3. Central Data Review

  • Remote Data Review
  • Safety Data Review

4. Monitoring Visits

  • Source Documentation Verification
  • Site Quality Verification
  • Remote Contacts
  • Off-site Monitoring Activities