ArisGlobal, a leading provider of integrated and cloud-based software solutions for life sciences, announced that LifeSphere Safety MultiVigilance is the first pharmacovigilance solution (version 7.4.1.1-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 (EMA) 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.”