At the TCC, we provide full safety management and reporting services for all types of clinical studies. These include:
- recording and notifying appropriate bodies of serious adverse events and suspected unexpected serious adverse reactions.
- creating and maintaining adverse event databases.
- receiving notices of and recording adverse events.
- coding of adverse events.
- notifying the investigator of adverse events.
- reporting to ethics committees and regulatory agencies.
- writing adverse event reports.
- and review by a clinical monitor.
Hence, we can help you to meet all applicable regulations about the safety of human subjects enrolled in clinical studies.