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PPD Functional Service Partnership (FSP) Pharmacovigilance Solutions

Our Solutions Clinical Development Functional Service Partnership Solutions FSP Pharmacovigilance

Flexible solutions underscoring a commitment to patient safety

An unwavering dedication to excellence in patient safety is of the utmost importance for drug developers, but it can be a challenge to keep pace with evolving pharmacovigilance regulations and technologies. Success requires proactive engagement with industry changes — and an approach that places quality and innovation first — for products that are in development or on the market.

Whether you need an end-to-end global pharmacovigilance solution or discrete pharmacovigilance functions to complement your existing infrastructure, our PPD™ Functional Service Partnership (FSP) Pharmacovigilance solutions deliver the experience, talent and tools you need to help maintain your regulatory compliance as a sponsor or marketing authorization holder.

Ready to transform your approach to pharmacovigilance?

Ensuring Effective Pharmacovigilance Regulatory Intelligence with FSP Partnership

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Safety Reporting in Clinical Trials: Six Core Considerations for Success
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Transitioning pharmacovigilance services to a single FSP partner
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Global resourcing maximizes pharmacovigilance operations to help clients meet their timelines
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Breadth and depth of pharmacovigilance expertise

Experience matters, which is why over 1,100 biopharmaceutical, biotech and medical device organizations have turned to PPD FSP Pharmacovigilance solutions over the years for pharmacovigilance support.

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years of experience

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companies supported since 1997

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pharmacovigilance experts in 35 countries

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endpoint dossiers adjudicated

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ICSR cycles processed annually

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recipients sent individual case safety reports (ICSRs) each year

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on-time safety reporting compliance rate

The ease of a single, flexible, capable partner

By choosing an experienced, industry-leading functional service provider for your pharmacovigilance solutions, you gain a collaborator with a proven track record of stable, high-quality services and the convenience and ease of a single global partner.

With over 30 years of pharmacovigilance and FSP expertise, our solutions support all of your clinical trial and post-marketing service needs and bring robust therapeutic area experience and global expertise from more than 35 countries.

Integrated capabilities include:

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  • Case processing
  • Artificial intelligence (AI) driven automated case intake
  • Safety reporting
  • Global literature services
  • Safety science including signal management
  • Safety writing
  • EU/UK specialty services
  • Local pharmacovigilance services
  • Pharmacovigilance agreement (PVA) management
  • Medical safety evaluation and risk mitigation (M-SERM) physicians
  • Pharmacovigilance consulting
  • Pharmacovigilance technology consulting
  • Medical good clinical practice (GCP)services
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Get the right experience, knowledge and expertise from top-tier professionals

To manage your complex pharmacovigilance efforts, you need professional know-how. That’s why you should choose a contract research organization (CRO) with a deep bench of more than 1,400 pharmacovigilance experts, comprising highly trained physicians, pharmacists, nurses, medical scientists and health care professionals.

But expertise isn’t enough – you need stability. Our clinical research team’s culture of professional development and learning fosters commitment that, in turn, delivers business continuity and the confidence that your programs are supported by dedicated professionals who keep their fingers on the pulse of the industry and apply the right experience, knowledge and expertise throughout your product’s life cycle.

To keep employees on top of ever-evolving regulations and technology changes, we offer award-winning employee development programs. Trainings include corporate and departmental training, mentoring and shadowing, as well as training developed specifically for pharmacovigilance client programs. Our professional development and learning culture make us a great company to work for, thereby increasing pharmacovigilance employee engagement and retention (average tenure is 6 years for senior & principal level staff and 8.5 years for manager level and above). Our industry-leading retention delivers business continuity and the confidence of knowing that your pharmacovigilance system is supported by quality professionals who apply the right experience, knowledge, and expertise.

Download the PPD FSP Pharmacovigilance solutions brochure

Advanced systems enhancing patient safety monitoring

As drug development activity increases1, drug developers face complex and evolving global regulations driven by growing adverse event volume and constant new streams of data. To successfully navigate the changing environment, biotech and biopharma companies need pharmacovigilance solutions that leverage new technologies, analytics, process improvements and automation to gain efficiencies; improve quality; increase consistency, accuracy and reliability; and reduce the pharmacovigilance cost burden.

We are continuously innovating and advancing the systems, processes and technologies that assure excellence in your patient safety monitoring. To unlock efficiencies, we offer a range of bespoke pharmacovigilance technology capabilities, tools and systems, including:

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  • Safety database
  • AI-driven automated case intake solution
  • Integrated med comm/pharmacovigilance solution
  • Rules-based automation and generative AI
  • Safety tracking system (STS)
  • Centralized regulatory agency (RA) & ethics committees (EC) submission tracking (CREST)
  • WCG’s SafetyVigilance®
  • RegView
  • Electronic Data Capture (EDC) Safety Link

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Ready to transform your approach to pharmacovigilance? Connect with our team for customized approaches that provide resource flexibility, reliability and continuity.