Argus Upgrade

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Overview

Oracle Argus Safety 8.x release comes with major updates to Electronic Submissions of E2B reports, along with critical enhancements such as Global Lock & Local Lock, eVAERS submission, and the ICSR Validation Framework. Argus Safety 8.x allows authoring of Periodic Reports using Oracle BI Publisher. Argus Safety traditionally supported Axway Cyclone as the gateway for exchange of E2B files with the Regulatory Authorities. Starting with 8.x, Argus now supports Oracle B2B gateway in addition to Axway.

Vitrana Team

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.

Business Configuration

Owing to the vast experience of design and implementing safety solutions to various customers, Vitrana understands the Safety configuration that will help a pharmaceutical organization to quickly get going and become compliant with E2B(R3) submissions. Gold configurations of Argus Safety 8.x suite are readily available with us which can help in accelerated delivery of solution and implementation of global best practices.

The consulting teams at Vitrana have vast and extensive expertise on regulations and have lead numerous complex R3 Transition and IDMP programs.

The track entails the following activity set:

  • Business Process Design
  • User requirement and configuration specifications
  • Configuration workshops
  • Conference Room Pilots
  • Configuration Builds
  • Development of Customizations
  • SOP Updates

Data Migration

Vitrana Safety Consulting teams have experienced bi-lingual resources with industry specific background and extensive experience of Data Migration across Safety Systems (ClinTrace, AERS, Argus, Perceive, Trackwise, Aster, Prodocumal).

The teams have lead more than 15 Migration Programs involving large Global and Japanese Pharmaceutical organizations. The program complexity involves data from multiple source safety systems, existed in different timelines with intensive de-duplication & data merge.

Vitrana has built a Data Migration & Integration Framework to accelerate complex migrations.

On-premise and Cloud Deployment

Vitrana is one of the pioneers of implementing Argus Safety on Cloud. We have partnered with Rackspace, one of the leading Cloud platform provider. The service model entails the following key attributes:

  • Database Administration and Optimization
  • E2B gateway / pilot testing support
  • E2B R3 BFC adapter and SME services
  • Disaster Recovery Planning & Testing
  • Cutover / Hypercare planning & rollout

Managed Services

Vitrana 24X7, follows the sun model with best in class infrastructure ensures delivery of application managed services for business critical safety systems. The team has bilingual capabilities with offshore operations ensuring highly cost effective services.

Build Your Team @ Vitrana (BYT @ Vitrana) offers a unique value preposition where customers can directly manage the team constitution and cost ensuring highest level of control and transparency. The service model entails the following key attributes:

  • Issues, enhancements, or queries managed to completion
  • Facilitate adherence to SLAs agreed with business
  • End-to-end service management

Integration

Vitrana integration services portfolio has an extensive coverage of popular industry solutions including Argus,  Medidata, Inform, Oracle Clinical, ONPOINT CTMS.

Vitrana Integration SME’s  have delivered integrations between clinical and safety systems for 4 of the Top 10 Pharma

Vitrana have developed numerous accelerators to support integration among:

  • Argus Safety & Inform
  • Argus Safety & Oracle Clinical
  • Argus Safety & Medidata
  • Argus Safety and Salesforce
  • Argus Safety & SAP

Reporting & Analytics

Vitrana Analytics Center of Excellence have delivered 300+ Japanese and English reports for drug safety organizations using all leading BI tools (OBIEE, BIP, Cognos, Business Objects, Spotfire and Tableau). Vitrana’s extensive exposure to multitude of Reporting and Analytics tools assist customers in choosing the right tool for the Reporting and Dashboard requirements.

Vitrana have invested in developing an open source reference warehouse model which can assist organizations to expedite the implementation program. The reporting and analytics services are categorized under following sub-groups:

  • Mart/ETL Design & Development
  • Analysis, Design & Development of custom reports

Validation

Vitrana Validation Center of Excellence have extensive experience in leading complex validation programs for safety implementation, upgrade, migration, reporting and integration. The team has bilingual (Japanese & English) capabilities. Many of its validation analysts have extensive experience of working as part of core product validation team including Argus ensuring deep insight into inter-related dependencies and coverage.

Vitrana have developed numerous accelerators to support expedited execution of validation phase. It has standardized validation packages to support Safety implementation & upgrade programs:

  • Risk assessment, Validation strategy and planning
  • Validation scripts authoring (IQ, OQ, PQ)
  • Test execution & Summarization

Training

Vitrana have designed Instructor Led Training courses that covers the basic and advanced concepts of managing drug safety systems including Argus for Global & Japanese users. The trainings have been designed to cater to requirements of different user types and categorized under following groups:

  • End user training
  • Advanced user training
  • Business administrator training
  • System administrator training
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