Safety management

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.