Gain Comprehensive Insights on Your Drug Safety Operations with Oracle Argus Analytics
The safety data that is generated during clinical trials and post-market surveillance is essential in identifying potential safety issues related to drugs and medical devices. Analyzing safety data can help to identify patterns and trends that may indicate safety issues and can lead to proactive measures being taken to mitigate risks.
By using the Oracle Argus Analytics software tool, pharmaceutical companies and contract research organizations (CRO) can keep tab on how efficiently case processing is performed, their overall safety compliance with regulatory authorities, and a day to day assessment of drug safety personnel required to maintain a smooth operation of the drug safety department.
Oracle Argus Analytics is an analytical and transactional reporting application based on a predefined set of key performance indicators (KPIs), facts, and dimensions with support for predefined and custom reporting. Oracle Argus Analytics also functions as a decision support system to monitor process bottlenecks and compliance deviations.
With the use of this analytical tool, users can generate out-of-the-box set of compliance metrics reports via Oracle Business Intelligence Enterprise Edition (OBIEE) that can be integrated with existing Argus Safety application. The interactive OBIEE dashboard will provide solutions to business questions and present data in charts, pivot tables, and reports. The results could be further enhanced through charting, result layout and drill-down features.
Key Features of Oracle Argus Analytics
- A single data-warehousing platform that facilitates integration of both non-regulated and regulated data.
- Provides reports for the two key drug safety functional areas - Retrospective Workflow Metrics and Current Metrics.
- Rapidly create new reports using the extensive predefined cycle time, quality and volume based metrics across data management and drug safety operations processes.
- Extract such data from other database sources as well, subject to the development of separate Extract Transform Load (ETL) programs for each database source
How We Can Help
At Techsol, our Safety Tech team can support the generation of the following reports and dashboards to provide insights on your safety operations.
> Case Version Metrics Report – Provides answers related to the volume of cases, and the time taken to complete a case, at case version level.
> Case Routing History Report – Provides answers about how long it took to complete a workflow state (step) before transitioning to the next workflow state in a case. It will represent a log of all the workflow states an individual case safety report (ICSR) went through (routed to) in its workflow lifecycle.
> Case Workflow State History Report – Provides answers about all the workflow states that a case has been through and the number of times each workflow state was repeated in that case.
> Case Work History Report – Provides answers related to the details of the workflow states a case version went through in its workflow lifecycle. It can be used to derive the actual work time spent in each workflow state per user or the version or at the case level.
> User Case Work History Report – Provides answers related to the total time a user spends in working on a case version, total actual work time spent in each workflow state, average time spent in working on one case version by one user in one workflow state.
> Expedited Report History Report – Provide answers related to the timeliness and volume of single case report submissions, which includes expedited reports and reports sent to a business partner for submission, in relation to the regulatory due date.
> Report Routing History Report – Provides answers related to the details of the workflow states an expedited report went through (routed to) in its workflow lifecycle.
> Pending Cases Report – Provides answers related to pending on-time, due soon and overdue cases.
> Pending Report – Provides answers related to pending, due soon, and overdue single case report submissions, which includes expedited reports and reports sent to a business partner for submission, in relation to the regulatory due date.
Service FAQs
Oracle Argus Analytics is delivered with a bunch of pre-defined reports. A subset of these reports is displayed on your dashboard pages, based on the user group you are assigned to.
A report can contain data in a tabular format, pivot table, or graph. You can filter the data visible on the report based on certain criteria such as Program, Study, Users, User Group, etc. These filters are called prompts. Some reports let you drill down to a more detailed report.
Pharmacovigilance Organizations require insights into the following key drug safety business process areas that impact the performance of drug safety operation within a case processing site/multiple case processing sites:
Case Receipt Compliance: Adverse event reports must be received by the drug safety department within the time frame as defined by the business in its Standard Operating Procedure (SOP) from internal as well as external sources.
Case Volume: In order to assess the balance of required drug safety personnel versus the number of cases received on a daily basis, the drug Safety management needs to view the overall volume of cases including but not limited to subsets of serious vs. non-serious, case type, product type, pregnancy and lactation exposure cases (with/without adverse events) etc.
Case Processing Time: Drug Safety management continually needs to determine if the cases are processed in an efficient and timely manner and ideally without needing re-work, in order to meet the regulatory submission deadlines.
Cases Processed by a User/User Group: Drug Safety management requires the ability to determine if the workload is balanced. The number of cases processed by each user enables management to review how the work is being accomplished and understand how many cases a person can handle.
Workload Allocation for Open/Current Cases: Drug safety management needs the ability to view real-time open work, the associated status, its due date, and the amount of time it has been in a given status so workload can be proactively managed and continue to be balanced and re-balanced in the cases of personnel absence, vacations or over allocation.
Compliance Maintenance: Drug safety departments need to process their expedited cases in a time-critical manner since the expedited reporting due date begins incrementing after the first employee or an agent of the company first learns about the adverse event associated with a company product.
Pregnancy Case Tracking: Pregnancy case tracking includes counting pregnancy cases with and without adverse events. This information is typically needed for PSUR pregnancy section preparation and/or maintaining pregnancy registries.
Root Cause Analysis: Regulatory submissions are late for a reason and a case may have a global and/or a local root cause for being late. The reason each submission is late needs be determined and tracked since the ability to categorize the root cause enables the company to take the necessary corrective and preventive measures.
