Arisglobal’s Total Safety™ Addresses Complete Scope Of Drug Safety, Pharmacovigilance And Risk Management Needs
ArisGlobal, LLC, a leading provider of software solutions for the life sciences industries, introduces TOTAL SAFETY, a comprehensive, scalable suite of applications designed to meet the broad spectrum of drug safety, pharmacovigilance and risk management needs of pharmaceutical, biotechnology, medical device and contract research organizations (CROs).
As life sciences organizations face increased scrutiny from consumers, health care professionals, regulatory agencies and legislators, it is more critical than ever before for them to take a proactive, holistic approach to the way adverse event cases are received, processed, tracked, analyzed and reported at all stages of development and throughout the entire product lifecycle.
“All of our customers have the same mission: to ensure that today’s medicines meet the highest standards of safety, quality and efficacy,” said John D. Kofoed, Director of Strategic Programs for ArisGlobal. “However these external pressures require expanding the scope of their safety and pharmacovigilance programs. Pharma executives know that technology is a major component of this strategy, and as a result have increased the demand for advanced IT solutions and services.”
TOTAL SAFETY has evolved through ArisGlobal’s collaborative partnerships with its diverse base of over 100 customers, incorporating best practices with technology in order to achieve the desired improvements in regulatory compliance, operational efficiency and information management.
TOTAL SAFETY is comprised of integrated, complementary applications which may be implemented as a complete suite or on a standalone basis, depending on individual business needs. Each component is designed to support integration with legacy systems, and is compatible with the most commonly used technology infrastructures in the industry.
The TOTAL SAFETY™ Suite includes:
ARISg™: Since 1987, ARISg has been the industry standard for global Adverse Event reporting. It features flexible and powerful case intake and case handling utilities – including an advanced workflow tool – as well as an advanced MedDRA coder/browser and report writing tool to support global agency reporting requirements.
agXchange™: More companies in the US, EU and Japan use agXchange for secure electronic submission of safety case information to regulatory agencies and among partners than any other electronic gateway tool. agXchange is also a secure, extensible data exchange platform that can be used in conjunction with any Oracle-compliant safety system.
SafetyMart™: An essential application for implementing a proactive safety, pharmacovigilance and risk management plan. SafetyMart allows you to extract data from ARISg or any other safety system, from your CDMS, or via subscription from the FDA AERS and WHO-UMC databases for broad analysis, ad hoc reporting and signal detection using several standard algorithms.
SafetyComposer™: An advanced report writing tool for meeting ever-changing regulatory periodic reporting requirements (e.g. PSURs) and internal reporting needs. SafetyComposer features scheduling, authoring and user-friendly report-building capabilities.
ClinicalConnect™: Provide connectivity and transfer of information from your CDMS to ARISg™ or other safety systems. Reconciliation utilities ensure AE and CDMS information is in sync.
“In today’s environment, drug and device companies have a hard time interpreting new guidance documents and complying with new regulations and legislation,” said Mark Loudon, Director of Regulatory Compliance at ArisGlobal “This is especially difficult when marketing products in the European Union, where local and central regulations may be in conflict or are unclear. Because ArisGlobal supports such a diverse group of customers, we are uniquely positioned to understand the pharmacovigilance and risk management challenges companies face. We use that knowledge to drive product enhancements and inform the industry through seminars, webcasts and user groups.”
About ArisGlobal
Founded in 1987, ArisGlobal is a leading provider of Pharmacovigilance and Safety, Registration Information Management, Clinical Trials Management and Medical Communications software solutions to the pharmaceutical, biotechnology, medical device and clinical research organization (CRO) markets. ArisGlobal counts 9 of the top 15 pharmaceutical providers and 5 of the top 10 biotechnology firms among its customers, as well as many mid-tier and smaller companies. ArisGlobal software helps companies meet international regulatory requirements, manage risk, improve operational efficiencies and easily share mission-critical information on a global basis. http://www.arisglobal.com
