Vitrana is a front runner in understanding the nuances of ICH E2B(R3) with its own product offering in Vitrana TransformPV with predefined E2B mappings for EMA, VAERS and EMDR. Vitrana Safety consulting team has an advantage over other service providers in helping the pharmaceutical organizations adopt E2B(R3) with Argus Safety 8.x as it has a better understanding of the Regulatory requirements pertaining to E2B(R3).
Vitrana has a team of professionals which has extensive experience in authoring complex reports and line listings using Oracle BI Publisher.
The Consulting & Engineering teams at Vitrana have collective experience of leading 25+ Drug Safety implementations including Argus and ClinTrace) across Top 50 Pharma’s & CROs, including system assessments, business process definition and redesigns, PV operations mergers and optimization projects. The team has its consultants and engineers who were part of the Argus and other safety solution product development and integration teams, with experience reaching back to initial product releases., with a thorough knowledge of the domain. Vitrana consultants have developed key insights and solutions as it relates to process integration between Global & Japanese safety operations. The team has multilingual capabilities with proficiency in English, German and Japanese language.