Pharmacovigilance

Our proactive approach enhances 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 matters. Our proactive approach allows us to get ahead of safety problems and maintain trial integrity and a lower risk profile. We use the latest safety technology and leverage our near real time analytics platform, Danah, to identify safety trends to enhance risk control.

Our staff are highly skilled MDs or hold an advance degree in life sciences, and they are fully versed in the regulatory safety requierements and with deep therapeutic expertise.

Our safety services

Eudravigilance responsible persons
Safety database set-ups
SAEs/SUSARs management and reporting
Patients’ narratives
Annual safety report generation and submission
SAEs reconciliations
Safety advisory boards

Using cutting-edge technology to monitor safety trends, ensuring your trial maintains integrity and a lower risk profile.

>4,000

SAEs and SUSARs processed

39

Countries providing a truly global coverage

70

Clients trusted us

Our Solutions for Biotechs

We offer end-to-end clinical development solutions tailored to your needs. Whether you’re preparing for first-in-human or managing a global Phase 3 trial, our agile team delivers expertise, insight, and hands-on support at every stage.

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