Mastering Inspector Access: Streamlining Regulatory Reviews
Regulatory inspections can be complex and demanding, but a well-prepared Trial Master File (TMF) can significantly ease the process.
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Streamline Safety Letter Distribution and Compliance
Track and store safety letters, ensuring investigative sites receive, acknowledge, and act on critical safety notifications.
Get Faster and Compliant Safety Notifications
Handling safety letters effectively is critical to make sure site staff are informed about potential risks and adverse events during clinical trials. To ensure compliance with regulatory timelines and efficient communication on-site, Trial Interactive’s Safety Letter Notifications automate the distribution, tracking, and acknowledgment process.
Our solution is designed for sponsors, CROs, and sites to manage safety letters ensuring compliance, efficiency, and transparency, while minimizing manual work and the risk of errors.
Comprehensive Safety Letter Management
Trial Interactive’s Safety Letter Management solution provides a validated, dedicated repository to electronically store and track safety letters and investigative site acknowledgements for products that are being studied in clinical trials. It provides a mechanism for sponsors to ensure responsible staff members at their investigative sites have been notified and proactively acknowledge the notification in a validated, secure repository. If desired, sponsors or CROs It also enables a review team to follow essential processes for information collection and document access.
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Build investigative sites, add contacts, and assign acknowledgement responsibilities to contacts at investigative sites
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Ensure all safety event documents are viewed and acknowledged with automated tracking and reminders
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Author, collaborate on, and approve safety letters using an optional workflow and document management process
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Flexibly distribute safety letters via system notifications or email attachments, with built-in tracking for non-system users.
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Comprehensive reporting using centralized dashboards for pending, overdue, and completed acknowledgements, along with site-specific compliance reports
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21 CFR 11 compliant audit trail, tracking user, document, and workflow actions
Why Choose Trial Interactive's Safety Letter Solutions?
Automated Compliance Tracking
Maintain adherence to global regulatory standards, including formal acknowledgements for investigator reviews with integrated workflows that trigger follow-ups for overdue responses.
Boost Efficiency
Replace manual tracking with automated notifications and oversight tools. Ensure no regulatory notification deadlines are missed with configurable reminders and alerts.
Risk Mitigation
Clear oversight tools reduce the risk of missed safety communications, ensuring participant safety. Central management of acknowledgements and team notifications ensures clear tracking of safety events in the site communication log
Regulatory Compliance
Detailed audit trails ensure all acknowledgement activity is tracked to meet EMA, FDA, and other global regulatory requirements. Enhanced, HITRUST-certified security and system management ensures no data leakage or privacy issues.
Simplified Processes
Reduce manual tracking with automated notifications and streamlined workflows. Configuration ensures the right people at each site are notified and acknowledge, with standardization across product, protocol, country, and site.
Ease of Use
Available within an intuitive system that is designed for investigators with minimal training requirements. Streamlined reporting provides a clear set of accountabilities for audit readiness and patient safety.
Key Features
Fully 21 CFR Part 11-compliant system with a comprehensive audit trail for complete regulatory assurance.
Easily upload and distribute safety letters, with automated notifications and reminders for acknowledgments.
Track acknowledgment statuses and manage compliance across all sites in real time.
Import site data seamlessly and share acknowledgments directly with eTMF or eISF systems.
Ideal for sponsors, CROs, investigators, and safety leads, ensuring efficient processes and regulatory compliance.
Add details about KPI reports, compliance dashboards, and customizable reporting for site-level insights.
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