Overview
Business Intelligence has become a very important analytical tool for the pharmaceutical and related industries as more business operations are run globally in today's electronically wired world. 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, it will be possible for the drug safety management to generate out-of-the-box set of compliance metrics reports via Oracle Business Intelligence Enterprise Edition (OBIEE) that can be integrated with existing Oracle 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.
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.
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