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.
PPD’s 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 organizational stability that comes with years of experience, capabilities from extensive onboarding 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.
PPD has extensive experience efficiently and successfully managing and controlling project scope, schedule and cost, while supporting safety and compliance with global regulatory requirements. Our systems ensure you maintain safety and compliance requirements. Critical technology platforms include:
- Safety database hosting with:
- ArisGlobal’s ARISg and ARISj
- Oracle’s ARGUS
- Safety investigator reporting with ArisGlobal’s AgNotify
PPD’s motivated pharmacovigilance staff offers stability that comes from years of experience, capabilities from extensive onboarding and continuous training processes, and firsthand knowledge of complex regulatory requirements.