Transition to Oracle Argus Safety – Key Considerations – Part 1

In the last three years, I have seen a lot of customers migrating, upgrading or switching to Oracle Argus Safety. In this context I thought I will share my 2 cents about some of the key considerations for the teams driving the transition.

Oracle’s Argus Safety Platform is evolving and will continue to evolve over the course of the years. We have come a long way from the erstwhile Relsys days of Argus 4.x to more recent Oracle’s 7.x releases. During this journey, a lot of customers who bought into the product may or may not have moved on to the new versions. This, combined with typical technology currency lethargy associated with Life Sciences organizations (for obvious reasons) has made it a very difficult transition for sponsors using Argus. The other category of customers include ones with either a custom application (typically home grown)  or one of the other safety suites (ARISg, AERS, Trace etc.). The transition for these customers is even more tedious as this may involve changes at multiple levels.

Irrespective of the source system, the transition is a long journey with various roadblocks along the way. In this context, I would like to highlight some key considerations for the team’s leading this transformation. The diagram below highlights the topics I consider as critical items, in my opinion:

Argus Transformation - Key COnsiderations

Argus Transformation – Key Considerations

If you consider the generic aspects (non-Safety) of a transition like this, one area that stands out is “Change Management”.  Also, the change should be managed across multiple functions of the organization. Based on my experience with typical organization setup, across multiple sponsors I have worked with, the most common layers are: Business Process Services, Business Support (Help Desk & Product Configuration can be combined in this category) and Application Support. Let’s look at key aspects, from a Change Management perspective for the above three layers below:

  • Business Process Services:
    • Process Re-Engineering: This is one of the most critical parts of the transition. More so, if the sponsor is moving from a non-Argus environment to Argus. Many a times customers try to configure their existing business process. Despite Argus being a configurable system, this may not yield optimum outcome. Therefore, process re-engineering is a critical activity to be undertaken.
    • Process Standardization: In the current world of mergers and acquisitions, it is not uncommon that an organization may have multiple safety systems. This might be the case across geographies (typically Japan). Hence, for organizations that desire a global Argus system (even though Argus Safety and Argus Japan are two modules in the Argus suite) it is essential that they consider standardization of processes. This will be particularly useful in being able to provide better support to the system and also simplifies the business process across the organization.
    • Global Compliance: While “One Size fits all” may not work. It is always good to think about global compliance needs when setting up the business processes, procedures and personnel. This is more relevant when Argus is chosen as the Global Drug Safety tool of choice
  • Business Support:
    • Learning Management: Many of the personnel in the safety organization would need training on Argus Safety. This may not only require product training but also process training, in the context of Argus.
    • Configuration Management: This in itself will be a huge exercise, not only to migrate configuration data from existing system but also to transform the configuration to fit into Argus. At times this might require additional training to the staff and/or setting up of a new team to handle Argus Business and System Configuration.
    • Known Errors and Work Arounds: Over a period of time the KEDB for the current system would have grown to a huge extent and might be leveraged to improve response times for any incidents. There should be plans made to reuse and or seed the new Known Error Database (KEDB) with some standard information that can be provided by either Oracle or other sources.
  • Application Support:
    • Sourcing Strategy: Argus skill set is required to effectively support the product. This may mean looking for a different vendor from the one that might be supporting the current system. This might be the case even if the system is currently being supported by the sponsor, using internal IT personnel.
    • Support Transition: This is one of the critical activities, if not done right, will not only sets back the entire transition but also may result in fines, if the AEs are not reported to regulators in time.
    • Operational Efficiency: The existing team will be operating at an optimum level. This may also be true in terms of tools and accelerators developed over a period of time by the current team. The transition will force the efficiency to take a hit. So, it is essential to account for this change and plan accordingly.

While the above items only correspond to the Change Management, I will post my thoughts on the remainder of the considerations in subsequent posts. As always, I will be happy to receive feedback and inputs from you.

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About Venu Mallarapu

I am currently working as Associate Director at Cognizant Technology Services in their Life Sciences division. I have over 15 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for about 9 years. I have worked with small to large pharma customers to address various business requirements in R&D, Sales and Marketing areas. IT Service Management is one of my other passions. I blog and write about technology frequently and have also presented at various conferences and workshops on wide variety of topics in technology.

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