
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 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.
Ensuring Effective Pharmacovigilance Regulatory Intelligence with FSP Partnership
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.
years of experience
companies supported since 1997
pharmacovigilance experts in 35 countries
endpoint dossiers adjudicated
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:
- 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
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:
- 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
Contact us
Ready to transform your approach to pharmacovigilance? Connect with our team for customized approaches that provide resource flexibility, reliability and continuity.