Clinigen’s end-to-end services are tailored to support your goals, ensuring patient safety, regulatory compliance and streamlined processes combining quality and value.
With our global framework of experienced QPPVs and local contact persons, we ensure you have experts in place to serve as your regulatory liaison to monitor evolving requirements impacting your PV program.
Our comprehensive offering manages your entire PV program, from intake, processing and medical review with signal detection and risk management procedures helping to reduce risks to patient health.
The cutting-edge tools at your disposal include a central safety database, providing secure access to a single, reliable source for global reporting and safety signal detection.
Our analytics dashboard offers a broad view of your portfolio, enabling you to make data-driven decisions with clarity and precision. Automated literature searches give you comprehensive coverage, enhanced accuracy and time savings.
Across the Clinigen portfolio, we aim to be both service provider and dedicated ally, with responsive service that ensures smooth communication, expert guidance and flexibility to adapt to your evolving needs.
Partnering with us saves you the cost of in-house databases and systems and gives you the confidence of knowing you’re backed by mature processes and subject matter experts.
With our support in alleviating the PV burden, you can concentrate on the priorities that drive your goals forward.
What our partners say
“As part of our full-service offering, we are very proud to partner with Clinigen for pharmacovigilance operations and we consistently receive excellent and expert service possible. The team excels at ensuring that the needs of clients are met, particularly the assurance of compliance with FDA regulations regarding drug safety reporting. Clinigen has been a great partner on numerous studies including several pivotal trials due to their knowledgeable counsel, excellent responsiveness, and superb teamwork.”
Client President