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Pharmacovigilance

For more than 20 years, PPD’s pharmacovigilance (PV) team has been delivering end-to-end PV services to more than 575 biopharmaceutical and medical device companies. Whether you require a complete global pharmacovigilance and risk management solution or individual services to support your existing infrastructure, our experts collaborate across all areas of clinical development to meet your needs.

Embedded within PV’s 1,400+ global staff is a culture built upon process improvement. We continually strive to increase efficiencies by challenging the status quo and targeting practical investments in game-changing initiatives. We welcome the opportunity to bring our experience to you, with an aim of utilizing innovative strategies to drive efficiencies. PPD’s strategic approach will result in time – and resource savings, allowing you to continue focusing on discovering and developing innovative, best-in-class drugs.

Rely on our skilled team of experts in strategic locations across 28 countries, with PV regulatory intelligence for over 100 countries.

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Marketed Products

Marketed Products

In addition to clinical trial support, PPD’s global PV 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. PPD offers the capability to coordinate activities both regionally and globally, ensuring business continuity and cost-effective solutions via the use of our low-cost, high quality locations inclusive of Bulgaria, India and the Philippines.

PV’s industry experience, alongside our proven success in process automation and artificial intelligence, provides our clients the flexibility and experience to reduce costs without compromising scientific data integrity and quality.

Services Include:

  • Case processing and literature surveillance
  • Global safety report submissions
  • Aggregate safety report preparation
  • Signal detection
  • Qualified person responsible for pharmacovigilance (QPPV)
  • Pharmacovigilance system master file (PSMF) development and maintenance
  • PV consultancy
  • Labeling (core safety information) support
  • Risk management plan authoring
  • Regulatory authority assessment report responses

Safety and Monitoring Reporting

Our clinical development group gives clients access to a dedicated PV 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, we provide safety coverage 24 hours a day, seven days a week. In addition, PV medical monitors provide support for protocol inquiries from sites, safety data review in the form of listings or via utilization of software applications for trending, laboratory data review and other tasks based on client needs. Our comprehensive, flexible suite of PV services support the life cycle of a clinical trial.

Services include:

  • Case processing and literature surveillance
  • Global safety report submissions
  • Endpoint adjudication coordination
  • Sequence WebEAS
  • Data safety monitoring board (DSMB) coordination
  • Development safety update reports (DSUR)
  • Provision of responsible person for EudraVigilance

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 Databases – ARISg, ARGUS and Argus options – Comprehensive adverse event management in industry-leading safety systems.
  • Safety Tracking System (STS) – Proprietary business process management system to manage productivity and quality.
  • Centralized RA & EC Submission Tracking (CREST) – Regulatory agency and ethics committee submission management tool.
  • Electronic Protocol Inquiry Platform (ePIP) – Electronic protocol inquiry submission and management platform.
  • Literature Import Tool – Import citations from Ovid database searches or from clients while automatically reconciling duplicates.
  • WebEAS (Cysis) – End-to-end adjudication process in a single web-based system.
  • Signal detection through Spotfire – PPD’s real-time data analysis solution.
  • ARIS Global AgNotify – Efficient delivery of safety reports to investigators.

Dedicated Experts

PPD’s teams and tenured leaders offer program stability that comes from years of experience. Our team’s proven solutions and exceptional quality ensure the successful delivery of pharmacovigilance services from safety locations around the world.

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