Medical Monitoring

Experienced, Comprehensive Medical Monitoring

At the heart of your study is the medicine. With an average of more than 25 years of academic, clinical and industry experience, our medical monitors have deep therapeutic knowledge and clinical experience. We provide both strategic and specific advice to sponsors, the sites and project teams throughout the life of your study.

Prior to the study, we provide:

• Consultation on study design, including, but not limited to, patient selection, endpoint determination, feasibility assessment and site selection
• Collaboration with the sponsor to devise a Medical Monitoring Plan
• Therapeutic area/indication training of project team
• Present at Investigator’s Meeting
• Attendance at scheduled meetings

During and after study conduct:

• Medical review of eligibility
• Review of lab critical values
• 24/7 emergency coverage for safety-related matters
• Ongoing medical support for investigator sites during the study
• Ongoing medical support for Monitors during the study
• Advice to the sites and study associates on protocol-related issues including: questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, follow-up visits due and guidance on prohibited medication
• Assistance in pharmacovigilance activities
• Communication with sponsor and study team as needed
• Provide input on medical topics for Question and Answer Logs and Newsletters, as needed
• Review of subject safety-related data in database(s)

Our medical monitor will develop a comprehensive medical plan, with your approval, that covers such elements as:

• Protocol-related issues
• Provide guidance on prohibited medications
• Questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, and follow-up visit

All of this is executed with full transparency and cooperation with the sponsor, through study meetings, conference calls, etc.

We apply our depth of knowledge and experience to ensure your study is safe and accurate.