Drug Safety and Pharmacovigilance
Where patient safety is concerned, data quality matters most
With ever evolving regulations, protecting patient safety is becoming more challenging whilst still demanding unwavering excellence. Success rests on proactive engagement with industry changes – and an approach that places quality and innovation first – whether your products are in development or on the market.
PPD Recognized by ISG as an Industry Leader in Pharmacovigilance and Regulatory Affairs
COMPLETE PORTFOLIO OF HIGH-QUALITY GLOBAL SAFETY SOLUTIONS ACROSS THE PRODUCT LIFECYCLE
Focused on maintaining exceptional staff
As technology advances across the pharmacovigilance (PV) landscape, we’re thoughtfully evolving our workforce to be ready for what’s to come. Our priority is to ensure business continuity to adhere to regulations because patient safety matters.
- Committed to hiring talent and developing critical PV skills as the market changes
- Industry benchmarking to ensure best practices are always in place
- Dedicated to our employees’ career development and growth, which drives high retention and sets us apart from other organizations
Pharmacovigilance services are also offered as an FSP Model
Managing Safety more efficiently with business process management solutions
PPD’s PV team has implemented an internally developed tool called the Safety Tracking System (STS), used to monitor safety processes and workload coordination, providing high-quality and compliant safety deliverables.
Leading-edge innovations – more than systems
- Centralized RA & EC Submission Tracking (CREST) – Regulatory agency and ethics committee submission management tool.
- Safety Databases – PPD has offered hosting in Aris Global’s systems since 2012. We also have extensive experience in working in client systems.
- We also look to add technology enablers to augment the best-in-class solutions in our industry such as Robotic Process Automation.
- Monitoring trends with a view to embracing AI technologies when they prove to be stable and effective for PV use.
- PPD’s global team of experts share a strong culture of process improvement based on Lean Six Sigma. We’re continually working to increase our efficiency.
- PPD has instituted a stage-gate review process managed by senior leadership which includes clearly defined stages: planning, analysis, design, implementation, and monitoring.
- Our deep industry experience alongside our proven success in process automation allows us to assess the marketplace to vet viable solutions using sound processes/technique.
THE FLEXIBLE PV PARTNER FOR MARKETED PRODUCT SAFETY
Safeguard your regulatory compliance and manage risk over the lifetime of your product. PPD is uniquely positioned to coordinate end-to-end PV activities across the globe. Our teams provide oversight of daily PV operations, including interactions with medical affairs, regulatory affairs, clinical development and quality assurance.