Several factors are prompting organizations to adopt agBalance: ease of integration with existing safety systems, its ability to manage complex signal management process and regulatory requirements, the growing emphasis on risk management planning and effectiveness measurement, and a simpler, more intuitive user interface.
“In today’s digital world, with continued focus on patient safety in an increasingly stringent regulatory environment, organizations need an intelligent platform that allows their safety departments to manage information in the most effective and efficient manner possible,” said Sharad Prakash, Vice President, Safety Analytics and Risk Management at ArisGlobal. “agBalance enables end-to-end safety signal life cycle management through systematic processes resulting in well executed risk minimization strategies.”
One top-tier European pharmaceutical company faced a myriad of challenges, including the integration of its drug safety system and signal detection platform, an inability to manage signals from sources to recommendations, and complexity in producing time-critical business and regulatory reports. After careful evaluation, the company found agBalance perfectly fit its current and future needs for signal detection and risk management.
A European National Competent Authority selected agBalance for its intuitive user interface and robust workflow engine to streamline signal detection and management activities. agBalance’s better signal detection, pharmacovigilance analytics, and advanced visualization capabilities were significant differentiators.
A mid-tier, U.S.-based pharmaceutical company found the solution fits its needs with regards to drug safety system integration, its ability to access comprehensive pharmacovigilance analytics across all safety sources, and for the integrated Risk Management Planning and Distribution module to support regional and country-level requirements.
In Japan, a leading pharmaceutical company sought integration with its existing drug safety systems for local and foreign adverse event reports, the ability to analyze data from multiple sources, all in a solution that could respond to the company’s complex signal management processes.
“The global interest in agBalance underscores the importance organizations are placing on proactive safety surveillance and structured risk management strategies,” added Prakash.
ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, risk evaluation and mitigation strategies, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.