Safety Letter Delivery

SafetyVigilance is the modern Safety Notification system. This safety letter distribution system allows sponsors to designate safety letters to investigators, as required by the reporting process for Food and Drug Administration (FDA) approvals. It also offers acknowledgment of letter receipt and provides auditable reporting and compliance tracking. Sites can browse, acknowledge and retain suspected unexpected serious adverse reactions (SUSAR), serious adverse events (SAE), investigator's brochures (IB) and Line Listings as determined by study teams.

Your team needs to stay compliant with regulators for clinical trials to continue. Keeping track of safety letters and documents is key to maintaining compliance, as is ensuring that safety letters reach the right recipients. As there are many types of documents and safety letters involved in clinical trials, you need a system that will track and organize these letters. Using a safety letter delivery system like SafetyVigilance means site staff can perform their roles successfully.

3X Compliance Rates
A top 20 pharmaceutical company’s enterprise safety letter acknowledgement compliance results increased from 30% to 92% in 18 months.



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. You can also benefit from the collective regulatory compliance decisions across sponsor organizations.
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 incomplete assignments. You can review the data of an entire study or use filters to sort this information.
Eliminate non-required and redundant safety notifications in clinical trials while streamlining the process for review and acknowledgement of safety letter notifications. Reduce time and resources for site staff with consolidated email notifications. Send reminders are also sent to users who have not accessed their letters within a customizable timeframe.
InvestigatorSpace will push safety events, updated IBs, and acknowledgement reports to the electronic Trial Master File (eTMF) using the client’s specific mapping. Trifecta offers custom development as well as integrations with Clinical Trial Management Systems (CTMS) and pharmacovigilance (PV)/Case Management Software systems to further automate the safety letter notification process.
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Get ready to streamline the safety letter distribution process and reduce the burden on your site staff. The team of experts at Trifecta® is available to answerany questions you have about our integrated clinical solutions.Request a demo of our safety letter delivery system today to see how your site can increase compliance and improve its organization.