PharmaBASE: Drug Safety and Pharmacovigilance Management System
PharmaBASE is a modular and web-based database solution that digitizes all pharmacovigilance processes in full compliance with current legal regulations. It provides complete control over your drug safety processes, minimizes your risks, and accelerates your compliance processes.
Regulation-Compliant and Modular Security Management
- Full compliance with current legislation (EMA, FDA, TİTCK)
- Data structure supported by MedDRA, WHODrug and E2B(R3)
- Audit-ready, traceable and secure infrastructure
- Flexible use with modular structure
14+
PV Modules100%
ComplianceE2B(R3)
Standard2Dil
TR / ENComprehensive Pharmacovigilance Management
PharmaBASE integrates your drug safety processes into a single central platform. It digitizes all your pharmacovigilance operations, including adverse reaction reporting, periodic benefit-risk assessment reports (PYRDR), signal monitoring, risk management, quality systems, training, and contract management. By recording all your processes in an auditable, traceable, and institutionally sound manner, you gain complete control over your compliance processes.
Centralized and Traceable Data Security
PharmaBASE enables the secure execution of pharmacovigilance processes through user-based sessions and transaction histories.
Thanks to company and customer-based access authorizations, sensitive security data is managed in a controlled, transparent, and audit-ready manner.
Modular and Integrated Pharmacovigilance System Structure
In the PharmaBASE infrastructure, a comprehensive system is created with 14 main modules and sub-components related to these modules, covering all pharmacovigilance processes.
Each module is developed to be fully compliant with TİTCK, EMA, and FDA regulations.
In line with needs, the modules can operate both independently and fully integrated within the system.
Thanks to this flexible structure, the digitalization of all business processes and uninterrupted operational tracking are ensured.
Usage Models
Service-Integrated Infrastructure:
For companies that receive pharmacovigilance services from PharmaSoft, a robust operational infrastructure is created through PharmaBASE. Thanks to the service integration usage model, all drug safety processes are ensured to be carried out seamlessly, digitally and in full compliance with regulations.