SAFETY & MEDICAL MONITORING

A higher standard of quality.

From our safety tracking and medical monitoring to our clinical monitors on the ground, Ora’s team works together to uphold the highest quality standards to ensure the success of your trial, leveraging their extensive experience with devices and products across all clinical trial stages.

Medical Oversight from Qualified Ophthalmologists

Medical monitoring for Ora managed clinical trials is conducted by our team of in-house ophthalmologists, ensuring all adverse events, protocol deviations and concomitant medications are reviewed by individuals with a deep understanding of ocular disease. With a commitment to collaboration, our experts attend meetings and provide tailored training as needed for your team. These medical monitoring activities are governed by a mutually agreed upon Medical Monitoring Plan, guaranteeing comprehensive oversight and swift resolution of any challenges.

Clinical Monitoring: Your window to sites, data, and quality for your trial

Our Clinical Research Associates (CRAs) play a vital role in managing relationships with your selected sites, ensuring the efficient execution of clinical trials. Their primary focus lies in prioritizing subject safety, adherence to study protocols, and maintaining data integrity throughout the trial process. As integral members of cross-functional teams, CRAs:

Collaborate closely with various stakeholders to ensure the smooth coordination of trial activities
Offer valuable insights into site performance and the currency of data, contributing to evidence-based decision-making.
Uphold rigorous standards to uphold the integrity of our clinical research efforts.
Bring invaluable local expertise to your clinical trials, seamlessly adapting Ora’s global processes to suit the specific requirements of each country where the trial is conducted

Prioritizing Retention of our Exceptional Team Members

We believe the importance of having the right study team cannot be understated. We are committed to retaining our Clinical Research Associates (CRAs) by prioritizing their growth, development, and communication.

Our comprehensive Ora Academy training programs and monthly monitoring department meetings provide continuous learning opportunities and valuable feedback sessions.
We place a strong emphasis on workload management and uphold our company values by conducting regular 1:1 meetings to assess each CRA’s workload and ensure they are adequately supported.

Our in-house ophthalmologists offer 24/7 safety oversight and strategic guidance

• Ongoing adverse event (AE) review
• Monitoring for safety issues in similar trials
• Patient eligibility assessment
• AE analysis and response

• Safety report evaluation
• Management of dose escalation and toxicity
• SAE reporting and investigation

Take your practice to the next level with Ora.

With turn-key support systems in place, Clinical research gives you the opportunity to grow your practice and make a difference to those who matter most — patients.