We provide truly global safety and pharmacovigilance services.

In an ever changing safety, regulatory and development landscape, Pivotal will keep you in control of your drug safety and development programmes ensuring the highest safety levels. From early drug development through post-marketing surveillance we support our clients with their safety monitoring and reporting practices. Our staff are highly skilled medical and safety professionals, fully versed in the regulatory requirements and with deep therapeutic expertise. We use the latest ARGUS technology.

Services we provide:

• Report via Eudravigilance
• Eudravigilance Responsible Person / Qualified Person for Pharmacovigilance (QPPV)
• Safety database
• SAEs/SUSARs monitoring
• Patient narratives
• Annual safety reports and DSURs
• Interim safety listings
• SAEs reconciliation
• Participation in Safety Advisory Board
• Clinical trial risk management

We provide customised and comprehensive solutions to each of our clients’ project and a global coverage.