Pharmacovigilance involves the safety monitoring of all medicines including herbal and complimentary remedies, vaccines and biological substances. Risk management plan in Europe and Risk evaluation and mitigation strategies (REMS) services in U.S. are the standard part of pharmacovigilance planning. The process carries out in pharmacovigilance software are the fetched data are process and review for safety, perform report assessment, adverse event reporting and store clinical trials data are submitted to regulators authority including US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) etc.
Increased incidence of adverse drug reactions is key factor driving the growth of pharmacovigilance and drug safety software market. Other factors include, increasing in patient pooling of chronic and nonchronic disease, growing disease burden and aging geriatric population, growing complexity regarding drug safety regulations are boosting the growth of pharmacovigilance and drug safety software market globally.
High cost of installation and maintenance of pharmacovigilance software, lack of pharmacovigilance professionals and non-aviability of standards regulation are the factors hindering the growth of pharmacovigilance and drug safety software market.
The key players in pharmacovigilance and drug safety software market includes, United BioSource Corporation, Sparta Systems, Inc., ArisGlobal LLC., Extedo GmbH., Oracle International Corporation, Ennov Solutions, Inc., Sarjen Systems Pvt. Ltd., Online Business Applications, Inc., AB Cube, and Relsys International, Inc.
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