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Innovation & Technology > Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange - UNITY™dx

Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange – UNITY™dx

165+

Aggregate Reports

99.99%

Submission Compliance

Streamlined Management of Pharmacovigilance (PV) Agreement Compliance
At Soterius, we utilize our innovative platform, UNITY™dx™, to effectively manage compliance with Pharmacovigilance (PV) Agreements, significantly simplifying the complex process of tracking, sharing, and documenting safety obligations. UNITY™dx™ provides automated and secure distribution of safety data, including SUSARs, DSURs, and other essential documents, ensuring continuous, real-time compliance with PV Agreement terms throughout the clinical study lifecycle.

Real-Time Safety Data Sharing and PV Agreement Adherence
UNITY™dx™ delivers timely, compliant updates directly to clinical trial sites, sponsors, CROs, and other stakeholders, streamlining communication and minimizing the risk of non-compliance. Its multi-channel communication hub securely manages and tracks all data exchanges, facilitating transparent monitoring of PV Agreement obligations. By eliminating manual processes and enhancing accuracy, UNITY™dx™ ensures seamless adherence to global regulatory standards.

Automated Retrospective Reporting for Enhanced Compliance
UNITY™dx™ simplifies retrospective safety reporting, automating the compilation and distribution of safety data packages to all relevant parties. This proactive approach reduces manual effort, enhances accuracy, and ensures timely compliance, mitigating the risk of regulatory findings associated with PV Agreement management. With UNITY™dx™, Soterius delivers an efficient, secure, and compliant solution that enhances confidence in safety data management and reporting.

Automated PV Agreement Compliance: Streamlined distribution and tracking of safety obligations with UNITY™dx™.
Real-Time Safety Data Updates: Continuous and compliant delivery of SUSARs, DSURs, and other critical documents.
Secure Multi-Channel Communication: Enhanced collaboration among clinical sites, sponsors, and CRO safety teams.
Simplified Retrospective Reporting: Automated safety package compilation reduces compliance risk and manual workload.
Comprehensive Compliance Tracking: Ensures accurate adherence to PV Agreement terms, minimizing regulatory risk.