BRANY offers study monitoring services to investigators conducting investigator-initiated clinical trials. Not only is monitoring required by the NIH, the FDA and other national/international best practice models (e.g., Good Clinical Practice), it is also needed to ensure the safety of all subjects involved in clinical investigations.
The obligation of monitoring falls to the investigator in investigator-initiated trials. Our Study Monitoring Service helps investigators meet their trial monitoring obligations, providing independent oversight of the trial (for the life of the trial) and verifying that the trial is in compliance with the currently approved protocol and applicable regulatory requirements.
Study monitoring activities conducted by our service include:
- Study start-up meetings
- Regular monitoring visits (on-site and remotely) to review study materials (regulatory files, consent forms, case report forms, drug/device accountability logs, etc)
- Close-out visits
BRANY’S monitoring team includes clinical research professionals all with over ten years research experience. These professionals are well versed in the regulations governing research including:
International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guidelines