- Sponsors must be assured that clinical trials are conducted in compliance with good clinical practices so that risks to humans are minimized, rights of human subjects are protected, and data collected are reliable. Our goal is to focus on conducting clinical data audits. Such audits can detect problems while there is still time to correct them.
- Some of the common findings include source document issues, poor compliance with procedures and study medication, missing endpoints, inconsistent reporting of adverse events and training and site personnel issues. Even good study monitoring is insufficient to detect and resolve all potentially serious issues. Some problems are obscure even to an experienced monitor.
- CTI wants to help sponsors manage risk by conducting clinical site audits and re-monitoring, if necessary. We provide this re-assurance throughout the trial with experienced, senior level clinical auditors. The audit plan will be customized for each study with the sponsor's input. In addition, we will conduct GCP audits and auditing of Trial Master
File for North America and European sponsors.
For more information,
email CTI or call 858-342-8059.
