LifeSphere Safety MultiVigilance™ gives customers a single, one-stop solution for providing full compliance with meeting EMA E2B (R3) and avoids 'work-around' approach used by other pharmacovigilance (PV)solution vendors
ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, today announced that LifeSphereSafetyMultiVigilance™ is the first pharmacovigilance solution (version 22.214.171.124-HF1) to have successfully completed E2B(R3) testing with the XCOMP EudraVigilance system. Organizations using this same tested version should contact the European Medicines Agency and confirm that step 5b can be performed by themselves without the need for confirmation by the Agency.
Meeting the November 22, 2017 deadline set by EMA will give ArisGlobal's 200+ customers the peace of mind that they will be fully compliant with EMA's landmark regulatory requirement. MAHs and contract research organizations benefit from a one-stop compliant solution to meet E2B (R3) submission and tracking requirements.
"The E2B (R3) guideline for the electronic transmission of individual case safety reports (ICSRs) is widely recognized as the single-most important pharmacovigilance requirement in the year 2017," said Dr. Vivek Ahuja, Vice President, Global Pharmacovigilance, ArisGlobal. "This time EMA also made the testing available to all PV solution vendors rather than just to the marketing authorization holders (MAHs). We are proud to be the first PV solutions provider to fully pass the testing of E2B (R3) import and export functionality."
While EMA allows backwards/forward conversion tools to be used as an alternative to a compliant solution, that approach is only a contingency plan and not a permanent solution. Drug safety software solution providers who require their customers to implement a conversion tool and then later need to upgrade to an EMA-compliant version of their PV solution once it passes testing, are adding steps, cost and burden to their customers.
"Our goal has always been to give our customers the smoothest journey in meeting their compliance requirements," said Sankesh Abbhi, Managing Director, ArisGlobal. "Leveraging LifeSphere's multi-tenant approach, we enable our customers to seamlessly benefit from this upgrade and compliance requirement."
LifeSphere Safety MultiVigilance™ is a modern, multi-tenant cloud-based pharmacovigilance system based on industry best practices and incorporates advanced technology such as cognitive computing and machine learning to automate the repetitive and routine manual tasks in case processing.
ArisGlobal is a visionary technology company that's transforming the way today's most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere™ cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.