Safety Letter Distribution
Streamline safety letter management and ensure compliance across all sites.
Experience seamless management of your safety reporting and letter distribution with InvestigatorSpace®, powered by WCG ClinSphereTM. With just a single login, monitors gain real-time access to training and safety records, including assignments and exemptions. This ensures compliance is maintained across all sites in your study, making the process smooth and efficient.
Centralize your safety letter management
Many sponsors experience challenges with their safety notification distribution, including unscalable manual processes for safety reporting, inability to manage and show compliance with global reporting regulations, and notification overload.
With WCG’s SafetyVigilance® safety reporting solution, part of the InvestigatorSpace® Training and Safety portal, you can support enterprise-wide safety letter distribution in a way that helps reduce burden on your sites and reduces unnecessary costs by:
- Eliminating labor-intensive, email-dependent processes.
- Eliminating over- or under-distribution of notifications using country-level distribution rules.
- Eliminating non-required and redundant notifications.
- Streamlining the process for review and letter acknowledgement.
WCG’s Safety Letter Distribution solution helps sites manage letter assignments, notifications, and acknowledgements, all in one place.
Centralized Management:
Seamlessly manage your safety reporting and letter distribution in InvestigatorSpace® ensuring that all your safety notifications are delivered via a secure online platform, creating total visibility and traceability.
Real-Time Access:
Maintain compliance across all sites in your study by providing monitors real-time access to training and safety records, including training assignments and exemptions.
Delegation of Responsibilities:
Allow principal investigators to delegate safety letter acknowledgement responsibility to another site user with configurable delegation periods.
Letter Assignment:
Enable study teams to assign letters to any given user at their site, with options for single notifications across compounds and studies.
Compliance Tracking:
Assign safety letters to investigators, get acknowledgment of letter receipt, track compliance, and generate auditable reporting.