Achieve Seamless Data Reconciliation with ReconAI
Introducing ReconAI, PV Analytica's cutting-edge AI application designed to transform the way Life Sciences organizations reconcile data across diverse systems within the R&D function. With ReconAI, your organization can identify, resolve, and prevent data inconsistencies while ensuring compliance with stringent regulatory standards.
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Why ReconAI?
Data reconciliation across multiple systems is a complex and resource-intensive challenge, especially in the highly regulated Life Sciences sector. ReconAI simplifies and streamlines this process by:
Identifying Inconsistencies:
Automatically detects mismatched, incomplete, or conflicting data across R&D systems.
Provides a clear view of discrepancies, enabling teams to focus on resolution.
Recommending Resolutions:
Delivers actionable recommendations to address inconsistencies, whether in data formatting, missing values, or system integrations.
Prioritizes critical issues that impact compliance and decision-making.
Enhancing Regulatory Compliance:
Ensures data accuracy and integrity to meet FDA, EMA, and other global regulatory requirements.
Provides audit-ready reports, documenting data reconciliation efforts and their outcomes.
5 Key Examples Where ReconAI Delivers Business Value
Clinical Trial Data Reconciliation
Challenge: Discrepancies between data in Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS) can lead to delays in trial timelines.
Value Delivered: ReconAI identifies mismatched patient data, enrollment numbers, and trial outcomes in real time, providing resolution suggestions to ensure accurate reporting for regulatory submissions.
Safety Data Integration
Challenge: Inconsistent safety data across pharmacovigilance systems and Clinical EDC systems increases the risk of non-compliance.
Value Delivered: ReconAI harmonizes adverse event reports, ensuring consistency between safety databases and clinical EDC, reducing compliance risks.
Regulatory Submission Datasets
Challenge: Errors in datasets submitted to regulators (e.g., FDA, EMA) can result in rejections or delays.
Value Delivered: ReconAI validates datasets such as CDISC SDTM and ADaM for consistency and completeness, ensuring they meet global submission standards.
Vendor and Partner Collaboration
Challenge: Misaligned data between internal teams and external partners (e.g., CROs or CMOs) creates bottlenecks in R&D processes.
Value Delivered: ReconAI ensures consistent data flow across systems, reducing miscommunication and enabling seamless collaboration with partners.
Cross-System Regulatory Reporting
Challenge: Generating accurate, audit-ready reports from multiple disconnected systems is time-consuming and error-prone.
Value Delivered: ReconAI automates the reconciliation of data across systems, producing comprehensive and compliant reports that are ready for regulatory inspections.
Key Features of ReconAI
Automated Data Reconciliation:
Continuously monitors and reconciles data across R&D platforms, including clinical, regulatory, and safety systems.Identifies discrepancies in real time, reducing delays in workflows.
Intelligent Recommendations:
Provides data correction and harmonization suggestions based on industry best practices. Leverages AI to learn from past reconciliations and improve future recommendations.
Regulatory-Focused Reporting:
Generates comprehensive, audit-ready documentation for all reconciliation activities.
Aligns reconciliation processes with regulatory guidelines, ensuring inspection readiness.
Cross-System Integration:
Integrates seamlessly with popular R&D platforms, including EDC, CTMS, safety databases, and regulatory submission tools.Ensures a unified approach to data management across the organization.
Proactive Alerts:
Notifies teams of potential risks and inconsistencies before they escalate into larger issues. Enables timely intervention to maintain data integrity.
Regulatory and Business Impact
ReconAI is not just a tool—it’s a strategic enabler for:
Accelerating R&D Processes:
Reduces delays caused by data inconsistencies, helping bring life-saving therapies to market faster.
Ensuring Inspection Readiness:
Keeps organizations prepared for audits with accurate and up-to-date reconciliation documentation.
Fostering Trust in Data:
Builds confidence among internal teams, regulatory bodies, and external partners by delivering consistent and reliable data.
