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PPD Functional Service Partnership (FSP) Pharmacovigilance Solutions

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 (PV) 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 a full global pharmacovigilance solution or discrete pharmacovigilance functions to complement your existing infrastructure, our PPD FSP Pharmacovigilance solutions deliver the end-to-end capabilities you need to generate evidence that demonstrates the effectiveness, safety and value of your product.

Ensuring Effective Regulatory Intelligence in Pharmacovigilance White Paper

Global resourcing maximizes pharmacovigilance operations to help clients meet their timelines

Breadth and depth of pharmacovigilance expertise

Experience matters, which is why over 900 biopharmaceutical, biotech and medical device organizations have turned to the PPDTM clinical research business of Thermo Fisher Scientific over the years for end-to-end pharmacovigilance solutions.

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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 25 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:

End-to-end case processing – with or without medical review – for all case types from clinical to post-marketing.

Global capabilities backed by robust regulatory intelligence for both individual case safety reports (ICSRs) and aggregate safety report submissions.

Clinical and post-marketing surveillance activities, including ICSR detection and review for signal detection purposes.

Activities to detect, validate, assess and track potential signals.

Full suite of aggregate safety reports and risk management plan (RMP) writing to meet lifecycle needs.

Setup and maintenance of complex global pharmacovigilance systems and participation in non-routine pharmacovigilance activities, as well as EudraVigilance profile management, Qualified Person Responsible for Pharmacovigilance (QPPV), and pharmacovigilance system master file (PSMF) development and maintenance.

Physicians are strategically distributed in global hubs to provide services around the clock.

Fulfills adjudication/clinical endpoint committee (CEC) and data safety monitoring board (DSMB) requirements.

Guidance to establish a new pharmacovigilance system, evolve existing systems or meet regulations in a new region.

Where possible, through a centralized model using multilingual hubs.

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 1,500 pharmacovigilance experts, comprising highly trained physicians, pharmacists, 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: core curriculum, departmental training, mentoring and shadowing, as well as training developed specifically for pharmacovigilance client programs. Our professional development and learning culture also help 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).

Download the PPD FSP Pharmacovigilance solutions brochure

Enhancing patient safety monitoring with advanced systems

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 committed to continuously innovating and advancing the systems, processes, and technologies that assure excellence in your patient safety monitoring.

Investigator site safety report distribution and clinical monitoring tool.

Adverse event management through ArisGlobal, Argus and client systems.

Proprietary tool to monitor safety processes and workload coordination, providing high-quality and compliant safety deliverables.

Regulatory agency and ethics committee submission management tool.

Proprietary regulatory intelligence platform to collect country specific rules and regulations.

Web-based platform providing a 21 CFR Par 11-compliant pathway for sites to submit inquiries to the PPD clinical research business of Thermo Fisher Scientific and client physician teams.

Contact us

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