Pharmacovigilance

Premier Research has the global expertise to manage product safety surveillance to the highest standards, across the product life cycle. Our global pharmacovigilance team provides comprehensive safety support through all stages of drug development.

Before a product is authorized and when it’s marketed, patient safety is paramount. Effective management and monitoring of safety data is essential to clinical trial success, and the scientists and healthcare professionals who comprise our global pharmacovigilance and device safety team provide high-quality and timely safety support in all phases of product development.

Our experts in the U.S. and Europe understand drug development and the challenges investigative sites face. They are supported by a safety network that has detailed local knowledge and expertise and is fluent in local languages, medical practices, and culture. We continually update our knowledge to keep up with evolving regulatory requirements for patient safety in clinical trials.

Benefits

Experience: Our global team has extensive pharma and device experience and is responsive to your needs.

Flexibility: Use these capabilities as part of a full-service offering, or choose from a range of standalone services such as medical safety writing, safety database hosting and maintenance, and pharmacovigilance consulting.

Expedited reporting: You receive full-service and periodic reports when you need them.

Our difference is our people

  • In-house physicians who are board-certified and board-registered.
  • Safety professionals with experience ranging from big pharma to small biotechs.
  • Expertise in pre- and post-marketing safety surveillance for medicinal products and medical devices.
  • Local safety representatives who support global teams with knowledge of regulatory requirements, medical practices, and local culture.
  • Dedicated medical safety writers who are experts at creating Periodic Benefit Risk Evaluation Reports, Development Safety Update Reports, Periodic Safety Update Reports, and Risk Management Plans.
  • Committed to continuing education on evolving regulatory requirements.

Support for full-service trials

We maintain stringent patient safety standards for each trial we manage and each service we provide, whatever the size. We are committed to providing the most comprehensive and effective product safety support possible.

  • Management of clinical trial SAEs/AESIs: triage, case assessment, follow-up, medical review, reporting.
  • Analysis of similar events
  • Device safety management
  • Annual and periodic safety reports
  • Expedited safety reporting, including EudraVigilance submissions
  • Document preparation: safety management plans, SAE report forms, follow-up questionnaires

Standalone services

  • Global safety database hosting:
    • Based on our in-house global safety system, Oracle Argus Safety
    • Gives customers and their pharmacovigilance providers access to their own dedicated safety database
    • We can create blinded and unblended accounts to give you peace of mind and data oversight without compromising the blinding status of your team
  • Medical safety writing services:
    • Periodic reports (ASRs, DSURs, PSURs, PBERs)
    • Preparation and review of risk management plans
    • Safety data exchange agreements
    • Pharmacovigilance systems standard operating procedures
  • EudraVigilance submissions
  • Entering and maintenance of medicinal products data in EudraVigilance
  • QPPV services
  • Signal management and risk-benefit analysis
  • Literature reviews
  • Consulting services:
    • Pharmacovigilance audits and inspection readiness
    • Audit/inspection preparation
    • Corrective actions and audit finding responses
    • Process modeling and improvement
    • Audits of pharmacovigilance systems
    • Pharmacovigilance training
  • Data and Safety Monitoring Board set-up
  • Medical monitoring services

Pharmacovigilance fact sheet

Pharmacovigilance Safety Database

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