A Case Study of Using an Accelerated Approach to Migrate to a Hosted Pharmacovigilance Solution

Commercialization and HEOR, Drug Safety, Life Sciences, Medical Device, Medical Device Safety and Regulation, Pharmaceutical, Pharmaceutical Regulation ,
  • Friday, June 15, 2018 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Argus Safety is the industry-leading solution for the management of adverse events in pharmacovigilance. The pharmasol rapidLIVE approach provides customers with the opportunity to implement a fully validated Argus Safety system within a few weeks.

In 2017, a US-based CRO was contracted by a pharmaceutical company to perform all pharmacovigilance activities on their behalf and to take on the legacy data for an in-licensed product.

Using pharmasol’s rapidLIVE approach, this CRO was able to smoothly and successfully go live with Oracle Argus 8.1 within two months. The migration of the legacy data was performed after they went live and more than 30,000 cases were migrated using an extended E2B(R2) methodology.

This case study shares our key learnings of how companies can significantly streamline their overall new system implementation, without going through a lengthy implementation project, while also minimizing risks, using pharmasol rapidLIVE to:

  • Effectively use industry-tested best-practice configurations from day one – a trademark of pharmasol’s rapidLIVE approach
  • Leverage a thorough, integrated validation package
  • Expediate training with workshops tailored to the best-practice processes and workflows
  • Migrate legacy data with methodologies maximizing data preservation while minimizing complex data transformations
  • Move existing Argus systems to our dedicated Argus hosting data centre

Speakers

Cheryl James, Principal Analyst, pharmasol

Cheryl has been in the pharmaceutical industry for the last 18 years and has over 12 years experience of working with Oracle Health Sciences suite, specifically Argus.

After her degree, she worked as part of a research group within a cutting edge medical centre sparking an interest in drug safety. She later took the opportunity to work in the newly created pharmacovigilance group at PPD, a global CRO, which provided interdisciplinary experience with various Oracle applications and multiple drug safety systems. When recruited to Oracle as an AERS consultant she was able to exploit the link between the implementation approach and SME business knowledge and perspective.

The last 10 years at pharmasol have been focused leading the development of the Argus rapidLIVE suite helping numerous companies go live with the world leading Argus Safety.

Message Presenter

Iain Barnden, Director Application Operations, pharmasol

Iain has worked in the pharmaceutical industry for over 30 years. He has experience with many industry-leading clinical data management, pharmacovigilance, clinical trial management, and data warehousing systems. He has taken leading roles in numerous implementation and strategic projects, and currently heads-up pharmaSOL’s IT applications group. Within the IT Applications Group Iain leads a global team responsible for the installation, upgrade, migration, maintenance and configuration of pharmasol’s hosted pharmacovigilance applications deployed over more than 100 servers.

Message Presenter

Who Should Attend?

Senior pharmacovigilance professionals, safety system analysts, pharmacovigilance/IT systems management

What You Will Learn

  • Effectively use industry-tested best-practice configurations from day one – a trademark of pharmasol’s rapidLIVE approach
  • Leverage a thorough, integrated validation package
  • Expediate training with workshops tailored to the best-practice processes and workflows
  • Migrate legacy data with methodologies maximizing data preservation while minimizing complex data transformations
  • Move existing Argus systems to our dedicated Argus hosting data centre

Xtalks Partner

pharmasol

pharmasol is a leading provider of innovative technology solutions, GxP compliant hosting and implementation services for the life sciences industry.

With headquarters in Germany and offices in the UK and the US, pharmasol has proven experience in delivering successful global projects across companies of all sizes.

With over 15 years’ experience in Data Management, Trial Operations and Pharmacovigilance, pharmasol staff are recognized as experts in developing software and providing support for industry leading applications.

pharmasol’s business and technical consultants have rich industry experience and are committed to providing efficient and innovative solutions and services.

For more information visit www.psixchange.com and www.pharmasol.de.

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