Arriello Modernizes Pharmacovigilance with Veeva Vault Safety

This video provides an overview of how Arriello, a leading provider of pharmacovigilance (PV) and regulatory affairs services since 2008, successfully implemented and utilized Veeva Vault Safety to modernize its operations. Ivan Mihalic, the Pharmacovigilance Safety System Manager at Arriello, shares his 12 years of experience in the IT industry and details the strategic advantages the platform offers to a service provider operating within the highly regulated life sciences sector. The core purpose of the implementation was to leverage a comprehensive, modern system that could support high-volume PV activities, manage regulatory connectivity, and facilitate rapid client expansion.

The adoption of Veeva Vault Safety yielded several critical operational benefits for Arriello. Foremost among these is the ability to utilize powerful reporting capabilities directly integrated within the safety database, streamlining the process of data analysis and insight generation. Furthermore, the system provides a crucial gateway connection, enabling seamless communication and data exchange with regulatory authorities and various partners. This regulatory connectivity is essential for maintaining compliance and timely submission of safety data. For a service provider like Arriello, the platform’s capacity to efficiently onboard new clients is a significant competitive advantage, supported by powerful features that enhance daily PV activities.

Mihalic characterizes Veeva Vault Safety as a modular web solution, highlighting its dual strengths: robust functionality combined with high flexibility regarding customization possibilities. This balance allows Arriello to tailor the system to specific client needs while relying on a standardized, powerful core. A notable achievement mentioned was the short implementation timeline, demonstrating the platform's readiness for rapid deployment. Crucially, the speaker emphasizes the value of Veeva’s structured release management process. This process provides detailed guidance before each new software update, which simplifies the application of new features for clients like Arriello and, most importantly, helps ensure the system remains in a "valid" state—a critical requirement for GxP and regulatory compliance in pharmacovigilance.

Key Takeaways: • Integrated Reporting Capabilities: Veeva Vault Safety provides direct access to powerful reporting features within the safety database itself, eliminating the need for complex external data extraction and integration for routine PV analysis and submissions. • Streamlined Regulatory Connectivity: The platform includes a built-in gateway connection designed to facilitate efficient and compliant data exchange with regulatory authorities (e.g., FDA, EMA) and external partners, ensuring timely safety reporting. • Competitive Advantage in Client Onboarding: For CROs and service providers like Arriello, the system's powerful features and architecture support the rapid and efficient onboarding of new clients, allowing for scalable growth and faster time-to-service delivery. • Balance of Power and Flexibility: Vault Safety is described as a modular web solution that offers robust, powerful functionalities while retaining significant flexibility for customization, allowing organizations to adapt the system to unique operational or client requirements. • Accelerated Implementation Timeline: Arriello experienced a "really short" implementation timeline, suggesting that the standardized nature of the Vault platform can significantly reduce deployment time compared to traditional, highly customized legacy safety systems. • Maintaining System Validity (Compliance Focus): The structured Veeva release management process is vital for regulatory compliance, providing detailed guidance that helps clients apply new software updates while ensuring the system maintains its validated state (critical for 21 CFR Part 11 and GxP environments). • Strategic Value for PV Service Providers: The system’s capabilities—especially in reporting, regulatory connectivity, and quick client onboarding—make it an ideal foundational technology for companies specializing in outsourced pharmacovigilance and regulatory affairs services. • Focus on Daily Activity Support: The platform is designed to offer powerful features that directly support and optimize the daily operational activities of pharmacovigilance teams, leading to increased efficiency and accuracy in case processing.

Tools/Resources Mentioned:

• Veeva Vault Safety: The core pharmacovigilance safety database and management platform discussed.
• Veeva Release Management: The structured process provided by Veeva for guiding clients through software updates to ensure system validity and compliance.

Key Concepts:

• Pharmacovigilance (PV): The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.
• Regulatory Affairs: The function responsible for ensuring that a company’s products comply with the regulations and laws of the regions where they are marketed.
• System Validity: In the context of regulated life sciences software (GxP), this refers to the state where a computerized system is documented, tested, and maintained to ensure it performs consistently and reliably according to its intended specifications and regulatory requirements.