STAMFORD, CT— March 25 2014 — ArisGlobal, a leading provider of solutions to the life-sciences industry, has launched Total Safety 7.1 – A comprehensive drug safety and pharmacovigilance system which enhances operational efficiencies, maintains regulatory compliance, and optimizes cost. Total Safety 7.1 is available as an on-premise solution, and on ArisGlobal’s SaaS delivery platform – agOnDemand; an integrated end-to-end platform hosted on a private, secure and validated life sciences Cloud. agOnDemand is a proven platform and has been hosting customers since 2007. It eliminates the need to invest in new software, hardware and infrastructure support. The ready-to-use pre-validated solutions available on the agOnDemand platform are cost-effective, reliable, configurable, scalable and require very little deployment time.
The Total Safety System provides extensive capabilities to support collection, assessment and distribution of both clinical and post-marketing Adverse Event and Adverse Reaction Reports. It offers comprehensive support for multiple product types such as drugs, devices, vaccines and their combinations.
This latest release of Total Safety delivers significant benefits enabling customers to:
• Achieve compliance and stay current with evolving regulatory requirements such as E2B(R3) and PMDA specifications
• Leverage Industry Standard Best Practices
• Improve operational efficiencies and simplify maintenance
• Reduce costs through increasingly flexible application infrastructure
• Simplify migrations from previous versions
The Total Safety 7.1 modular suite, spearheaded by market-leading ARISg™ and ARISjTM solutions, enables ArisGlobal customers to seamlessly add modular functionality, when and where they need it – and only when they’re ready. As the only single, global safety solution in the industry, ArisGlobal’s Total Safety is uniquely equipped for uniform, efficient operations that fully support all global submission and reporting requirements for EMA (European Medical Agency) and the FDA (US Food & Drug Administration), as well as regulatory reporting requirements to the MHLW/PMDA (Ministry of Health, Labor and Welfare / Pharmaceutical and Medical Device Agency) in Japan, plus many other national authorities.
Total Safety 7.1 encompasses many enhancements implemented previously individually, on request from customers. Such a unified functional release helps ArisGlobal deliver superior levels of performance and stability, thereby bringing greater value to our customers.
“This unified and E2B (R3) data compliant safety suite represents a significant milestone in the evolution of ArisGlobal’s Safety Solution,” said Dr Hans Mosberg, Vice President, Safety & Risk Management at ArisGlobal. “Without an integrated and global solution like our ARISg / ARISj–powered Total Safety 7.1 suite, companies would have to use several systems, with their respective databases, environments, configurations and workflows, and then duplicate or double enter-cases, which is both risky and inefficient. Because our clients are global, we have developed and now deliver the only globally accepted safety and pharmacovigilance solution that meets the needs of Europe, North America and Japan. Many of our existing customers are in advanced stages of planning for an imminent upgrade.”
ArisGlobal (www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality & compliance for medical inquiries. Solutions are available on premise or on a regulated cloud platform. Life science companies using ArisGlobal’s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world.
Tel + 44 (0)1908 506075