The primary goal of any clinical trial is the protection and safety of its participants throughout the study. We provide safety and medical monitoring for clinical studies. Our in-house medical experts, all of whom are board-certified physicians, provide the necessary review of safety data to identify potential safety trends throughout a trial. The Baim Institute Safety Officer reviews and processes every safety event, generating a descriptive narrative and completes the necessary regulatory forms (MedWatch, CIOMS), enabling the SAEs to be submitted to the required regulatory authorities. The study’s medical monitor is available to answer general protocol questions and provide guidance to sites clarifying whether particular patients are eligible for the clinical study.
Our Safety & Medical Monitoring team provides: