In my previous post titled “Transition to Oracle Argus Safety – Key Considerations – Part 1” I summarized the key considerations for Transition to Oracle Argus Safety. The Infographic included in the previous post, summarizes the considerations across the Business Process, Business Support and Application Support areas.
In this post, I will outline the considerations in Single Case Handling. This is one of the most resource intensive and critical functions of a safety organization. This is one function that cannot be interrupted, despite transition to a new tool/system, as it his many implications on the sponsor organization as well as on the patients.
- Business Process Services:
- Process Optimization: This is one of the aspects of the safety organization that will be impacted immediately. The business teams processing the cases would have reached their peak performance within the current environment. Introducing Argus will impact the team as they have to learn new tool and also readjust to a process that most likely was reengineered
- Case Receipt Automation: Many organizations would have automated the Case Intake process. The process of automation and any tools associated with it would have to be reengineered to leverage Argus’ Intake capabilities instead
- QA, Metrics & Best Practices: The quality assurance of the single case processing, the performance metrics associated with it and the best practices established over the course of time will all be impacted and probably take a dip with the introduction of Argus. This has to do more with the change in itself rather than the functions/features/capabilities of Argus tool
- Business Support:
- Access Management: The users need to be configured in the new system. Also, if any new users are being on boarded as part of consolidation then this will have to be accounted part as part of access management
- Partner Support: The Safety organization will have established relationships with CRO partners. These partners need to be supported during the transition. This might also mean reengineering some of the Intake processes, tools and systems. If Argus Affiliate module is being leveraged for capturing AEs from the affiliates, this could add additional entity to the support organization from a configuration as well as help desk support perspective.
- Report Distribution: The established channels of distribution of expedited reports to regulators will be impacted with the introduction of Argus. This might mean retesting any electronic E2B report submission channels. The review, approval and submission of reports may need to be configured using Argus and Argus Interchange modules.
- Application Support:
- Workflow Configuration: The Case Processing workflow need to be reconfigured. For large organizations this is usually a complex task as the automated routing of cases to the right groups/personnel is key to efficient processing. If a global consolidation is undertaken as part of the transition, this task would become even more complex.
- E2B and Reconciliation: The established process and tools for collection and/or distribution of safety data/reports to/from partners should be reengineered with the inroduction of Argus. Also, the safety case reconsiliation that happens between the clinical and safety systems will be impacted and should be reengineered and automated to account for changes due to Argus
- Distribution: As mentioned in the Business Support, the reporting process will be reconfigured, which will necessitate a reengineering of distribution process.
In the next part, we will look at additional considerations from an Aggregate Reporting perspective.
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:
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.
Adverse Events / Adverse Drug Reactions are imperative to all interventional therapies, be it drugs, devices, vaccines or biologics. The frequency, seriousness, breadth etc. may vary from drug to drug, person to person. We have made a lot of progress in ensuring that all the adverse events are identified, processed and reported to regulators. However there are still a lot of challenges in ensuring consistency, of how this is done across organizations, in terms of people, process and technology.
Oracle’s Argus Safety Suite is a leading drug safety system in the market. It is a very good application with rich features. However, there are still certain functions, the industry needs, that needs to mature and some others that are still evolving. I would like to write about one such features i.e. Adverse Event Reconciliation. The module in Argus Suite that provides this functionality is “Argus Reconciliation”. The datasheet lists the benefits of reconciliation and the ability of this module to make it easy, to reconcile the AE data between Argus and other Clinical Data Management systems.
What is reconciliation?
Reconciliation is typically the process of identifying any discrepancies in the data captured for the Adverse Events in Clinical Data Management system and Safety System.
Why do they have similar data in two systems?
Adverse event data is captured in CDM systems as part of the clinical trial data collection process. This data is also entered in Safety Systems in order to capture, process and report it to regulators. Sponsors should ensure that the data that is submitted to regulators during the course of the trial and the data that is submitted as part of the overall submission are consistent. Hence, reconciliation of data is essential. Ideally this situation should not arise if the data is collected electronically and the systems are integrated so the information flows bi-directionally. However, that is not the case in real world.
For customers that have Argus Safety there are essentially three options for reconciliation:
- Automated (COTS) and
- Automated (Custom)
Manual: This method, to a large extent is self-explanatory. One has to extract the AE records from the Safety and CDM systems and compare the data elements line item-by-line item. Any discrepancies identified may lead to a) change to the data in CDM system or b) change to the data in Safety system
Automated (COTS): This method can be used in case a commercially available integration exists between the CDM system and Argus. If we look at some of the popular CDM systems in the market, InForm (Oracle), Oracle Clinical and Rave (Medidata) two are from Oracle. The following information outlines the integration in case of each CDM system:
1) In case of Oracle Clinical, the reconciliation is available through the Argus Reconciliation module. Customers have to buy licenses to this module as part of the Safety Suite in order to leverage this functionality.
2) For Inform to Argus integration, Oracle has released a Process Integration Pack (PIP) that is part of their Application Integration Architecture (AIA), which in turn is part of their Fusion Middleware strategy. This essentially requires customers to install an AIA foundation pack and then purchase the PIP (Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety) and install/configure it.
3) Medidata Rave’s Safety Gateway product can be leveraged for integration between Rave and Argus Safety. This is basically an E2B based integration.
Automated (Custom): In cases where the volume of cases is very high, which eliminates the manual option, and a COTS integration does not exist, customers may have to rely on a custom integration. This can be accomplished in multiple ways. However, an E2B based integration is recommended.
Hope this post helps you get basic knowledge about AE reconciliation and options available for reconciliation between Argus Safety and three popular Clinical Data Management systems. As always, your feedback will be very valuable and welcome.
Many large Drug Safety organizations have initiatives to leverage the historical data available to them and measure the operational inefficiencies of their processes. In my opinion these initiatives are worth spending your dollar. With the increased scrutiny by regulators on patient safety, drastic increase of data sources and dwindling budgets, the more you know about how good or bad you are at managing your processes to handle safety cases is worth the investment.The challenge always is with deciding what do you want to measure beyond your typical KPIs that you’d get from standard reports made available by the drug safety system vendors. Also, how flexible is the tool in making it easy for your team to define additional KPIs, create dashboards/reports and combine historical data with current data to perform comparative analysis.
Oracle has quickly established themselves as a leader in the Drug Safety space through acquisition of Relsys and Phaseforward. They probably have 3x the customers compared to their nearest competitor for all of their three safety systems. While this creates confusion in the short term, Argus Safety is emerging as the strategic product that they would support and continue enhancements in the long run. One of the initiatives that has come to fruition around this tool is Argus Analytics (formerly Oracle Pharmacovigilance Analytics ot OPVA) which has been available as a general release for close to 2 years now. While it demands additional investment from sponsors, I think it is a good starting point for any sponsor or CRO trying to measure their operational efficiency, identify bottlenecks and improve their decision making process.
I will keep this post brief and not go into the details of each KPI/Dashboard that is available in Oracle Argus Analytics and give a list of dashboards available. Many of these are self explanatory. More information can be found in the user guide available online here: http://docs.oracle.com/cd/E35225_01/doc.11/e29106/toc.htm
|Case Processing History||Trailing||Enterprise ID||Case Processing Volume History|
|Case Processing Compliance History|
|Workflow State Repetition History|
|Case Processing Management||Current||Enterprise ID||Case Processing Volume Management|
|Case Processing Compliance Management|
|Workflow State Compliance Management|
|Personal User Dashboard||Trailing & Current||Enterprise ID||Personal User Case History|
|Personal User Case Management|
|Personal User Case Work History|
|Personal User Expedited Report History|
|Personal User Expedited Report Management|
|Expedited Report History||Expedited Submission Volume History|
|Expedited Non-Submission Volume History|
|Expedited Submission Compliance History|
|Expedited Report Management||Expedited Submission Volume Management|
|Expedited Submission Compliance Management|
|Expedited Failed/Pending ACK Volume Management|
|Case Work History||Case Modified History|
|Case Unmodified History|
|Case Read History|
|Case Idle History|
Hope this gives a high level idea about the various dashboards available in Argus Analytics.
Jumpstart your PV Operational Efficiency Improvement Initiatives through Oracle Pharmacovigilance Operational Analytics (OPVA)
I attended Oracle Open World (OOW) recently during the week of Oct 2nd. I got a sneak peek of the newly released Oracle Pharmacovigilance Operational Analytics tool. This tool is intended to provide a jumpstart to the efforts of Safety & Pharmacovigilance departments of MAHs and CROs in being able to monitor the operational performance of the organizations and identify the bottlenecks. The key point to note is that this tool provides only the Operational Analytics and doesn’t include the Scientific Analytics.
Some of the Key business benefits it will deliver include:
- Insights into the case processing operations
- Measure compliance and productivity across the organization
- Provide ability to monitor the KPIs and metrics through dashboards in real time
- Provide ability to drill down to identify the bottlenecks in the process
- Improve productivity and save costs across the organization
- Improve compliance and enable better patient safety
From IT Systems perspective:
- Single repository of operational safety data
- Star schemas that could be populated with data from internal and external sources
- Predefined reports, KPIs, Metrics and Dashboards
- Ability to customize and extend the dashboards and reports
- Ability to view current as well as historical operational performance of organization and individuals
- Out-of-the-box integration with Oracle’s Argus Safety
- Built using Oracle BI (OBIEE) which gives ability to view dashboards on web as well as on mobile devices (iPhones and iPads)
Some of the key dashboards that are provided out-of-the-box:
- Case processing history in terms of volumes, compliance and repetition
- Case processing management in terms of volumes, compliance and workflow state SLA management
- Personal user dashboards with individual’s case management and case history,
Some of the reports include:
- Completed case volume overview and trends
- Pending case volume overview and trends
- Case version line listings
- Individual case workload reports and line listings
OPVA is compatible with Argus Safety 6.0.2 and Argus Safety 7.0.
One of the key uses of OPVA for organizations that want to define additional metrics, KPIs, dashboards and reports is the start schema that is provided with the product. It comes with a set of predefined dimensions and facts that can be leveraged to speed up the process of developing the additional custom dashboards, KPIs, Metrics and Reports.
Dimensions provided by the OPVA schema are:
- List of Values
- User Group
- Case Processing Site
- Enterprise (in a multi-tenant scenario more relevant for CROs)
The pre-built facts into the OPVA data mart are:
- Case Version History
- Case Routing History
- Case Workflow History and
- Pending Cases
I think this is a very good addition by Oracle to its stable of products and compliments the existing tools quite well. This is also a very good tool for customers wanting to jumpstart their efforts to measuring their safety operations (aka Case Processing), identifying the bottlenecks in terms of compliance and productivity and rein in costs through improvement plans to enhance these aspects.