In our rapidly digitalizing world, all business sectors are working to constantly update the technologies that they use in order to keep up with this change. Automations play an important role in the modern and digital management of companies’ processes in the fields of pharmacovigilance and regulatory affairs, where we provide services as PharmaSoft. With the active use of technologies such as artificial intelligence, machine learning and big data, applications has been continuing to be developed to automate pharmacovigilance processes substantially. In this way, it is aimed to provide a more economical, fast, and efficient service to pharmaceutical companies by enabling signal management and easily collecting real-world evidence. In today’s post, we will share with you the vision of PharmaSoft in this field and the applications it has developed and worked on. We wish you pleasant reading!
PharmaSoft setted out with the “Modern and Digital Management in Pharmacovigilance and Regulatory Affairs” motto, in this direction PharmaSoft provides quality-oriented, effective, and agile service with its constantly renewing structure. PharmaSoft’s strong IT infrastructure since the day it was founded continues to meet the demands and the needs in this field, as a solution partner in the digitalization processes of the leading pharmaceutical companies, with the PharmaBASE Pharmacovigilance Database and PharmaSEARCH Literature Search applications.
More than 5000 medicinal products data are stored in the PharmaBASE pharmacovigilance database, which consists of 14 integrated modules with a completely secure electronic archive. Thanks to the Microsoft Azure partnership, the creation of data lakes that work seamlessly with our existing data warehouses also ensures data security and facilitates the processing of the data. In addition, big data operations and analysis are also carried out with Microsoft Azure integration. Also, all pharmacovigilance data duplication checks are performed automatically by PharmaBASE.
Being aware of the fact that one of the most important parts of the digitalization processes in the pharmacovigilance sector is signal management, the PharmaSoft team has developed the PharmaBASE Signal Management Module in line with the importance they attach to the subject. In this module, which meets all local and global quality requirements, the signal management processes are carried out in five steps in detail as; “detection, validation, approval, analysis, and evaluation”. In these processes, it is aimed to reduce the margin of error to zero by combining human skills and technology. In addition, it is important to collect real-world evidence from different sources in signal detection, due to the contribution of source diversity to the benefit-risk analysis of medicinal products.
Within the scope of a transparent working model and customer satisfaction policy, PharmaSoft allows its clients to see all the responsibilities carried out on behalf of the companies to which it provides pharmacovigilance department services, through PharmaBASE. In addition, the PharmaBASE Compliance Module offers an objective assessment with measurable key performance indicators.
PharmaSEARCH, another product of PharmaSoft that automates pharmacovigilance processes, offers a database of 610 medical journals updated three times a year for weekly medical literature searches. Users can also access historical literature review results through electronic library of PharmaSEARCH.
Pharmacovigilance sector-specific-softwares, developed by our information technology experts, are updated in line with new technologies. With the regular feedback of our sector-leader companies in the pharmaceutical industry, our systems continue to develop agilely in line with the new demands. In addition, PharmaSoft pharmacovigilance and information technologies teams closely follow the developments in the field of pharmacovigilance automation and work together to maximize the efficiency and quality of systems in our working environment where sharing ideas is one of the important values. Thanks to its flexible structure, ability to take quick action, and agile perspective, PharmaSoft continues its mission of being the solution address for providing effective, sustainable, modern and digital services by integrating new technologies with its expert team and strong infrastructure.
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See you again very soon, stay healthy,
PharmaSoft Atelier
