Pharmacovigilance Services

Our global pharmacovigilance team is comprised of physicians, pharmacists and other medically trained professionals. Our experts collaborate with clinical development, regulatory affairs and others, to ensure maximum success for your program.

Since 1995 we have delivered comprehensive, end-to-end pharmacovigilance services to more than 245 biopharmaceutical companies and medical device organisations.

Pharmacovigilance

Clinical Trials

Our clinical development group gives clients access to a dedicated pharmacovigilance team that advances your safety monitoring and safety reporting practices while allowing you to evaluate and manage risk over the lifetime of your product. With a highly skilled team of medical and safety professionals—with regulatory and safety experience—we provide safety coverage 24 hours a day, seven days a week. Our comprehensive, flexible suite of pharmacovigilance services support the life cycle of a clinical trial, including endpoint adjudication coordination, Sequence WebEAS and data safety monitoring board (DSMB) coordination.

Marketed Products

Our global pharmacovigilance group gives you access to flexible technologies, resourcing solutions, effective governance and continuous process improvement to meet the increasingly complex regulatory requirements for marketed products.

We offer organisational stability that comes with years of experience, capabilities from extensive on-boarding and continuous training processes, and firsthand knowledge of complex regulatory requirements. Our European Union specialty services include EudraVigilance profile management, qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) creation and management.