A Must-Have for Pharmacovigilance: NNIT’s Chinese-English Bilingual Pharmacovigilance Platform build on Argus
As a long-term strategic partner of Oracle, NNIT is the first supplier in China that spans the entire width of implementation services of Argus (installation, verification, training, operations, and maintenance, especially CN-EN bilingual synchronous solution) which, as the most excellent global Pharmacovigilance (PV) platform, has been recognized by FDA, WHO, and relevant EU regulatory authorities, becoming the prefered choice of PV platform among global pharmaceutical giants. The platform can help ensure efficient and accurate collection, rapid analysis, and timely notification of Adverse Event data to fulfill the global regulatory requirements. NNIT has a proven track record of implementation, operation, and maintenance of Argus and has already launched a Chinese-English bilingual
Argus PV platform based on our long-term experience and continuous investment in the field of R&D, WHICH IS CHARACTERIZED BY THE FOLLOWING MERITS:
• Monitors adverse events in the entire process from R&D, production to sales, covering such products as herbal medicines, traditional drugs, adjuvant drugs, blood products, biological products, medical devices, vaccines, and cosmetics, etc.;
• Embeds reports (IND/ASR/NDR/ICSR/PBRER/PSUR/DSUR/CTPR/EURD/CIOMS- I,II, III/MedWatch, etc.) and business flow conforming to requirements specified by FDA/EMA/WHO/ICH/HL7/- Canada/French/ German/United Kingdom and other various regulatory authorities;
• Supports electronic submission of ICH E2B (R2/R3), supports the FDA’ s latest eVAERS reports regarding vaccines, while supporting ISO-IDMP data standards;
• Synchronously completes the CN-EN bilingual version and medical encoding can satisfy the regulatory needs of both home (CFDA) and abroad;
• Seamless integrates with EDC (clinical data management system) to cut off the laborious efforts of data entry and review;
• Supports customization of operation procedures to realize inter-departmental collaboration among global PV, while time-line control and reminders are set up at each time-point of business flow to ensure timely submission of data;
• Embeds a validation module that can realize the rule verification of each critical data point and supports comparison and validation of multiple data points to further improve data quality and working efficiency;
• Embeds the E2B calibration module to ensure data integrity and compliance prior to electronic data submission (EDI);
• Supports the rapid import and use of MedDRA (Chinese-English version), WHODrug, and user-defined Chinese Pharmaceutical Dictionary;
• Detects Auto-Signals to enable timely vigilance and monitoring against critical risks;
• Multi-Tenant model that facilitates CRO to manage the adverse event data of multiple products from various enterprises at the same time and efficiently provides PV services;
• Embeds a computerized system verification (CSV) service package to enable regulatory compliance of the system with GXP validation upon its launch.
The benefits you will realize when partnering with us are anchored in the optimized supporting system which will help your enterprise concentrate on the direct use of the system without unnecessary efforts being spent on its implementation and setup.
The NNIT approach to Argus has eliminated many risks associated with the validation and review of the system so that all the components of a new system can immediately be initiated while avoiding unnecessary costs and delays. As Argus implementation partner, NNIT provides not only components required for immediate initiation of the new system but also all the services and additional items. Hence, your enterprise will benefit from a ready-to-use framework that will enable transfer of massive data to usable information and facilitate the implementation of effective PV measures accordingly.