Drug Safety and Pharmacovigilance |
Regulatory agencies in the US, Europe, and Japan are speeding up their efforts to finalize guidelines surrounding Pharmacovigilance.
As a result, companies should embrace proactive monitoring and industry best practices in order to demonstrate adequate processes, procedures, signaling capabilities, and documentation. Compliance with Good Pharmacovigilance Practice (GPvP) is essential for a company to demonstrate that it has followed the appropriate procedures during development and post-marketing in order to protect patient safety.
Intelligent Solutions-PVTM
Patni offers a variety of products and services that can be directly connected to impact your Adverse Event processing:
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Signal Intelligence-PVTM: Dramatically reduce the time and burden of analyzing Drug Safety data and preparation of aggregated reports including: PSURs, ASRs, ISSs. |
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Workflow Intelligence-PVTM: Enables companies to optimize AE case processing through the application of modeling and simulation to map resources, timing, and costs. |
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Operations Intelligence-PVTM: Our proprietary methodology focuses on eight major points and rates them against industry best practices producing quantifiable metrics.
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Signal Intelligence Services-PVTM : Outsourced solution for the analysis and reporting of signals in drug safety data. |
Signal Intelligence-PVTM
Overview - Dramatically reduce the time and burden of analyzing Drug Safety data and preparation of aggregated reports including: PSURs, ASRs, ISSs.
Easy-to-use, interactive, visual analytics speed time to insights and eliminate the need for static reports.
Provides interactive analysis results that enable confident, collaborative decision-making.
Turn Key Solution - Signal Intelligence-PV is an out-of-the-box solution for signal detection that can be used for Postmarketing and Clinical Safety. The system comes preconfigured with structured analyses that comply with FDA's Good Pharmacovigilance Practices.
Medical Relevance - The system is designed to be used by Healthcare Professionals to quickly and intuitively identify potential trends and outliers thereby applying 'meaning' to data.
Ease of Use - Step by step macro's, check-boxes, and sliders replace cumbersome sorting and charting.
Structured Yet Flexible - Predefined Macro's ensure consistent and reliable analysis procedures, while the user interface provides flexibility to view the data in multiple ways. Medical reviewers can run infinite what-if scenarios.
Signaling vs. Data Mining - Data Mining is the process of applying statistical algorithms to data to compare rate of incidence. Signaling is the interactive analysis of data based on human knowledge
Signal Intelligence-PV allows medical reviewers to work quickly with raw company data or layer it on top of data mining applications to apply medical relevance to statistics.
Integrate with other safety related systems to gain a panoramic view of your entire product safety mosaic.
Workflow Intelligence-PVTM
Enables companies to optimize Adverse Event case processing through the application of modeling and simulation to map resources, timing, and costs.
Workflow Intelligence-PV enables life sciences companies to:
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Align resources to high risk areas |
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Capitalize on the expertise of limited resources |
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Rapidly respond to fluctuations in case load |
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Identify opportunities to reduce costs |
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Define current case processing capacity |
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Improve capacity and reduce overhead |
Workflow Intelligence-PV allows a client to model the current process by using key performance and cost metrics to challenge the model in the areas of: |
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Workload capacity (initial cases (serious, non-serious), follow-up)) |
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Workflow = sequence of activities (who does what for how long) and business rules |
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Reporting compliance (expedited, periodic, operations) |
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Resource utilization (MDs, Safety Specialists, Coordinators) |
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Activity-based costing |
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| Operations Intelligence-PVTM |
Is your Drug Safety department prepared to handle a new product or merger?
Do you have an accurate and objective picture of your regulatory and business risks?
Is there an opportunity to streamline your current operation?
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Patni's Operations Intelligence-PV provides a truly unique approach to Drug Safety Assessments. Our proprietary methodology focuses on eight major points and rates them against industry best practices. Clients are given results in the form of quantifiable metrics that identify areas of strength and those that need further investment. Findings are documented and cross-referenced to the appropriate regulation
(FDA, EMEA).
How Patni Can Help
Patni brings the experience, expertise, and methodology to review clients' business processes and systems for the collection, assessment, reporting, and analysis of adverse events worldwide.
Patni has an established track record in Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice. We have leveraged our experience and expertise in these areas to deliver Good Pharmacovigilance Practice compliance consulting services.
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Patni evaluates a company's compliance to GPvP with respect to:
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Adverse event (AE) data received |
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Standard Operating Procedures (SOPs) followed |
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Analyses performed |
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Thresholds met or not met |
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Actions taken to triage and review potential signals |
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Subsequent label changes and other risk management activities |
Patni reviews your signaling and data mining approaches as they relate to the latest FDA guidelines:
Patni Signaling Services: |
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A formal methodology to apply statistical analysis to company safety data using proprietary templates and data visualization tools |
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Analysis includes comparison to public safety data to assess significance of internal findings |
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Results create a reproducible and legally defensible analysis of safety data |
Sample Signaling Project |
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Develop signaling specifications
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Extract AE data from source systems |
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Implement analysis templates |
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Include required FDA analyses per GPvp |
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Develop and deliver training |
Related Patni Services |
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