A proactive approach to enhance safety risk control
In a time of unprecedented acceleration in clinical development and ever-changing regulatory landscape, Pivotal will keep you in control of your drug safety. Our proactive approach allows us to get ahead of safety problems and maintain trial integrity and a lower risk profile. We use the latest Oracle Argus technology and leverage our near real-time analytics platform to identify safety trends. To enhance risk control.
Our staff are highly skilled medical and safety professionals, fully versed in the regulatory requirements and with deep therapeutic expertise.
Our service offerings:
- Eudravigilance Responsible Persons
- Safety database set-ups
- SAEs/SUSARs management and reportings
- Patient narratives
- Annual Safety Reports
- Development Safety Update Reports
- SAEs reconciliations
- Safety Advisory Boards