Medical Affairs & Clinical Research

By: Cincero  09-12-2011
Keywords: Patient Safety

Patient safety is the foundation of a successful trial. For this reason your patients’ safety and overall health is our highest priority. Each client is provided with a qualified Medical Monitor and a Medical Safety Associate (MSA).

The Medical Monitor will provide a medical review of specific patient data to determine possible safety issues of the indication, trends in adverse events, and overall review of patient safety.

Case Report Form (CRF) Safety Review:

The Medical Monitor will review selected CRFs specified by clients to ensure overall patient safety, trends and concerns. If necessary, the Medical Monitor or the MSA will follow up with site issues and will generate appropriate reports to clients.

The Cincero MSA will contact the sites to ensure completeness and accuracy of all relevant Serious Adverse Events (SAE) information. We also assume responsibility for the preparation of a subject narrative for every SAE report.

24 hrs hot line services:

Both the Cincero Medical Monitor and the MSA are available 24 hours for safety management through our hotline service.

Keywords: Patient Safety