Westat’s clinical trialWestat’s clinical trials practice pharmacovigilance (PVG) team supports the product development lifecycle every step of the way – from early-phase studies to regulatory approval. Our comprehensive services and validated adverse-event safety system help ensure not only vigilance but also credibility and rigor.

Comprehensive PVG Services

Our skilled PVG professionals draw on years of experience to offer end-to-end support, including:

• Development and execution of customized processes for collecting safety information
• Evaluation of safety information by expert medical monitors
• Reporting of safety information in compliance with regulatory guidelines

Skilled Support for Adverse Events

Westat understands and recognizes that adverse events are part of the clinical trials process. To prepare for such situations, our experienced PVG team offers safety surveillance services, including adverse event, laboratory, protocol compliance, endpoint, development of written safety plans and other relevant data reviews and trend analyses. We engage medical monitors and medical writers to prepare safety narratives.

When serious adverse events do occur, Westat relies on a validated, 21 Code of Federal Regulations (CFR) Part 11-compliant safety system for processing them. This system is seamlessly integrated with the data management system and uses E2B tags and customized programming. This allows for automated adverse event data transmissions that can significantly improve the accuracy and speed of safety data collection, evaluation, and reporting.

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