Medical Monitoring

Ora has in-house ophthalmologists with more than a decade of experience in academic universities and big pharma who serve as medical monitors and take an active role in every clinical trial.

Ora’s medical monitors have the safety of subjects as their primary responsibility. Medical monitors are available 24/7 to respond to any safety-related questions.

Activities of Ora’s Medical Monitors:

  • Reviews in an ongoing manner all adverse event (AE) listings
  • Maintains awareness of AE/Safety issues in other ongoing clinical trials with similar products, when possible
  • Responds to questions about patient eligibility
  • Reviews AEs and discusses any relationship or abnormal findings
  • Reviews coding reports for accuracy
  • Oversees dose escalation stopping rules and dose-limiting toxicity (DLTs)
  • Serious AE (SAE) Reporting
    • Upon immediate notification of an SAE report, the medical monitor reviews the report for completeness and queries the investigator for additional information as needed
    • Ora’s Safety Management Plans always include the flow chart for SAE communication
  • Reviews safety reports
  • Reviews final clinical study reports

Ora has a very clearly marked path for the transparent management of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) in US and international trials.

Pharmacovigilance

If safety reporting is what is required for your approved product, we offer this service in association with our sister company, SDC.

Read more on our Regulatory and Medical Writing and Submissions team.

Regulatory Development and Submissions