Pharmacovigilance Services

Ensuring Patient Safety

Providing Pharmacovigilance Services from Development to Market

PPD is committed to advancing the development of medicines for adults and children with rare diseases and we have developed solutions to reach, recruit and retain small, globally dispersed patient populations. By leveraging our medical, operational, regulatory and real-world expertise, we design and operationalize studies with the customized approach that each rare disease requires. We successfully execute trials with organizations of all sizes. In the past five years, we have conducted more rare disease studies than any other contract research organization (CRO).

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 1997 we have delivered comprehensive, end-to-end pharmacovigilance services to more than 575 biopharmaceutical companies and medical device organizations.

Pharmacovigilance expertise
Pharmacovigilance global reach

Clinical Trials

Pharmacovigilance clinical trials experienceOur 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

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.

Flexible Technologies

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

Dedicated Experts

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.

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