Our senior safety physicians and scientists are experts in designing, implementing and leading full risk management and pharmacovigilance (PV) programmes. This experience allows us to maintain a broad, global perspective when it comes to achieving regulatory approvals, securing label extensions and monitoring safety.
Experienced, hands-on, drug safety specialists are vital when negotiating the complex maze of global PV regulations.
Our drug safety and PV team works on a multitude of projects, from early clinical development through to post-licensing PV.
Our team of tranScrip experts helps with everything from PV inspection readiness and training, to planning for post-approval safety studies. Along the way, we also supply end-to-end safety signal management and access to a regulatory compliant in-house safety database.
The support we offer doesn't end there. Our specialists assist with Data and Safety Monitoring Board (DSMB) activities and offer guidance for any relevant drug safety training programmes. We can also provide a Qualified Person for Pharmacovigilance (EU/UK).
In terms of safety writing, every conceivable requirement is met by our team.
We have teams of life science and R&D experts to help achieve your goals and seize opportunities. Whatever your project requires, we have the people to meet your needs.