Safety Letter Delivery

SafetyVigilance® is the modern Safety Notification system, allowing sponsors to assign safety letters to investigators, offering acknowledgement of letter receipt, compliance tracking, and auditable reporting. Sites can browse, acknowledge and retain SUSAR’s, SAE’s, IB’s and Line Listings as determined by study teams.

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3X Compliance Rates

A top 20 pharmaceutical company’s enterprise safety letter acknowledgement compliance results increased from 30% to 92% in 18 months.

BENEFITS OF SAFETYVIGILANCE®

Automated Country-level Distribution

Eliminate “Over-Distribution” and “Under-Distribution” via configurable country-level distribution rules. Adhere to regulatory guidelines with ease and use Trifecta’s regulatory best practices across 144 countries to efficiently assign letters to designated users. And benefit from the collective regulatory compliance decisions across sponsor organizations.

Easily Track Acknowledgements of Letters

Reports can be generated at any time providing real-time metrics around safety document distribution. Timeline Report depicts the trend in time of letter assignments by sponsor, compound, study, country, and site. Compliance Report provides a comprehensive overview of compliance levels broken down by: sponsor, compound, study, country, and letter. Aging Report displays the distribution of assignments that are incomplete. Data can be displayed for an entire study or broken down by a variety of filters.

Reduce burden on Investigative Sites & Increase Compliance

Eliminate non-required and redundant notifications while streamlining the process for review and acknowledgement of safety letter notifications. Reduce time and resources for site staff with consolidated email notifications. Reminders are also sent to users who have not accessed their letters within a customizable timeframe.

Clintech Integrations

InvestigatorSpace® will push safety events, updated IB’s, as well as acknowledgement reports to the eTMF using the clients specific mapping. Trifecta offers custom development as well as integrations with CTMS and PV/Case Management Software systems to further automate the safety letter notification process.

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