Drug Safety
At Jubilant Clinsys Inc., patient safety is our number one priority. The Clinsys’ Global Safety Team has Phase I – IV drug and device safety experience. The team of drug safety specialists offers the following services as part of our full clinical trial management. Individual services can also be contracted.
- Creation of the Safety Management Plan
- Serious Adverse Event (SAE) and Unanticipated Adverse Device Effects (UADE) management and reporting
- Adverse event and clinical endpoint management and processing
- Safety reporting (MedWatch and CIOMS)
- Safety database management and reconciliation
- Full pharmacovigilance services