Data-driven clarity for complex regulations and clinical operations.

Overview

RWD-based safety evaluation aligned with ICH M14 and international standards.

End-to-end PMS support across study design, IRB processes, database setup, monitoring, and reporting.

Regulation-driven SOP gap analysis, process alignment, and organization-tailored SOP and appendix development.

One-stop PMS Support: PMS design → IRB → contracts → DB setup → monitoring → reporting.
Integrated Site Operations: SMO collaboration, dedicated CRCs, efficient patient enrollment.
Dedicated PMS PMs Strengthened timeline and quality management.

SOP gap analysis, integration of updated regulations/guidelines, and cross-functional process alignment.

Development of templates and forms, along with training and distribution for relevant teams.

Training materials and checklist packages to ensure seamless on-site implementation.

Pharmacovigilance experts with professional experience will specify the client's needs.

Customized service projects for clients, with transparent costs and contracts. (If necessary, proceeded with quality consulting)

Project team is assigned and PV service begins.

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