Azelix understands the importance of medical monitoring throughout a clinical trial. Our medical monitors are highly experienced professionals with diverse backgrounds in medical and academic institutions, and have the expertise to apply their practical knowledge and experiences to clinical trials.

Based on your area/indication of interest, we will assign a medical monitor that is therapeutically focused and understands the goals and objectives of your clinical development program. Our medical monitors are involved as early as the pre-IND stage to provide you with the expertise you may need as you navigate and plan your  overall drug development strategy. This would include protocol design such as defining inclusion and exclusion criteria and providing other safety-related input to ensure a well-balanced protocol from the regulatory, operational, and patient safety perspectives. At the time of study conduct, our medical monitoring team will be available 24 hours a day, 7 days a week to oversee the safety of trial subjects.

Azelix’s medical monitoring services include:

  • Medical consultation to optimize your clinical development plan and study design, review safety information and reporting, clinical study reports, and regulatory submissions
  • Medical point of contact responsible for ensuring product safety and regulatory interactions (if needed)
  • Serving in a leadership role to support investigator sites by providing therapeutic/study specific trainings, answering protocol-related questions, participating in dose-escalation decisions, and advising on medical emergencies