We can provide monitoring services for Sponsor-Investigator and Investigator-Initiated Multi-Center trials to oversee the progress of a clinical trial to ensure that the rights and well-being of human subjects are protected; the study is conducted, recorded and reported in accordance with the protocol, standard operating procedures, Good Clinical Practice and applicable regulatory requirement(s). (GCP 1.38)
Our staff is well trained to ensure the highest quality review of data and effective interaction with study sites. We can conduct on-site monitoring or remote-monitoring visits throughout the conduct of the trial to oversee data collection, verify informed consent was obtained and appropriately documented, eligibility confirmation, review source documentation and case report forms, ensure regulatory compliance, investigational product accountability if applicable, and assist with data query resolution.
Cost/Fee: Sponsor-Investigator will be billed for travel expenses and hours spent on monitoring preparation, actual time of monitoring and preparing follow up communications.
NIH rates will apply.
For more information
Michelle Jenkerson RN, BS, RRT, CCRC
Associate Director of Clinical Research