With the ever increasing flow of adverse event data and increasing focus on patient safety, there has never been a greater need to deliver better safety outcomes at the earliest possible point in a product’s lifecycle.
(PRWEB) June 16, 2015
ArisGlobal®, a leading provider of Cloud solutions to life sciences companies, is pleased to announce that it has acquired Medsight Solutions, including the revolutionary integrated risk management solution, Medsight Sapphire (now known as ArisGlobal agBalance™). The ArisGlobal agBalance™ solution is ready for immediate availability.
ArisGlobal agBalance™ represents a paradigm shift in how the pharmaceutical industry manages the benefit-risk profile of a drug throughout the drug lifecycle. Until now companies have had to rely on a complex, time consuming process with data scientists, safety leads and regulatory affairs staff to manage and communicate safety concerns from adverse event data. Now, ArisGlobal agBalance™ allows safety experts to directly engage in signal detection and drive the results through signals management into risk management. Regulators and the industry now have access to an integrated platform for detecting safety issues and communicating the changing benefit-risk profile of medicinal products to the health community in a timely manner.
Sharad Prakash, Founder of Medsight and now the Vice President of the newly formed Benefit Risk Management business unit at ArisGlobal® said, “With the ever increasing flow of adverse event data and increasing focus on patient safety, there has never been a greater need to deliver better safety outcomes at the earliest possible point in a product’s lifecycle. Delivered at a similar per-use cost as legacy tools and ad hoc solutions, an organization with ArisGlobal agBalance™ can now achieve a previously unattainable level of risk management productivity. This radically changes the risk management landscape for life sciences products, in the same way that the ‘spinning jenny’ changed production techniques and started the industrial revolution. I really can’t overstate what a change this will bring to pharmacovigilance.”
“Over the years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning pharmacovigilance and the introduction of Good Pharmacovigilance Practice (GVP) modules. There is a change in focus for companies and regulators which needs to be reflected in increased cross-functional working and continued benefit-risk assessments. ArisGlobal agBalance™ uses a systematic approach for life cycle benefit-risk assessment thereby assisting life sciences companies in managing the benefit-risk balance of their medicinal products. We are very excited to have ArisGlobal agBalance™ as a key part of our safety portfolio.” said Deepak Abbhi, CEO of ArisGlobal®.
For over 25 years ArisGlobal (http://www.arisglobal.com) has been 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.