Sold by: Virtusa CorporationÂ
Facing the daunting task of FDA clinical trial site inspections? Accelerate regulatory compliance for clinical trial inspections through AI-powered simulation. Virtusa's AI-Powered Inspection Readiness Platform transforms the complex validation of thousands of documents into a streamlined, intelligent process. Our suite of 8 specialized AI agents automates checklist validation against FDA regulations, providing you with clear, prioritized risk assessments (Critical/Major/Minor) and a quantifiable readiness score per site. By simulating FDA audits and offering a unified dashboard for tracking progress, we empower you to proactively identify gaps, mitigate risks, and confidently navigate inspections, saving time, ensuring consistency, and ultimately improving your chances of a successful outcome.
Overview
Proactive, AI-driven inspection readiness.
Virtusa’s AI Clinical Inspection Simulator transforms clinical trial site inspection readiness from a reactive burden into a proactive, data-driven strategy. By leveraging the power of AWS Gen AI services, our solution automates the meticulous inspection preparation process, providing unparalleled precision and efficiency. We empower you to identify and address potential compliance issues before they become critical, fostering a culture of continuous readiness and reducing the risk of costly delays and penalties.
Key Features and Benefits: Our comprehensive suite of AI-enabled tools and features ensures regulatory readiness and dynamic risk classification and simulates mock inspections.
a. AI-Agent Suite b. Dynamic Risk classification c. Readiness Scoring d. Mock Inspection e. Dashboard and Analytics
Highlights
- AI-Agent Suite A team of 8 specialized AI agents, each focused on a critical domain. Monitoring, subjects, sites, documents, training, investigational product, committees, and more. Automates the validation of key documents and processes against regulatory guidelines. Benefits: Comprehensive coverage of inspection areas, reducing manual effort and ensuring no critical detail is overlooked.
- Dynamic Risk Classification AI intelligently categorizes identified gaps into critical, major and minor, allowing for focused remediation efforts based on immediate impact and regulatory urgency. Benefits: Prioritizes risks effectively, enabling teams to address the most pressing issues and optimize resource allocation.
- Readiness Scoring Provides granular, site-level scores (0-100) and agent-level breakdowns, offering a clear, quantifiable measure of compliance status. Benchmarking capabilities allow for comparison across sites and against industry standards. Benefits: Offers objective, data-driven insights into readiness levels, facilitating informed decision making and targeted improvement strategies.
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Deployed on AWS
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