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.
Full Service Global Clinical Development
Celerion, a full-service, early clinical CRO, is the leader in accelerating development for Phase I-IIb. Our unique combination of medical expertise, clinical operations experience and scientific excellence, enables you to make timely decisions with expert advice and high-quality data. Our leadership in clinical pharmacology through Proof-of-Concept is focused on helping you translate your science to medicine.
