Signal Intelligence |
Signal Intelligence-PVTM
Signal Intelligence-PVTMis a formal validated signaling methodology that provides an efficient and scientific approach to understanding a product's risk-benefit profile.
Sophisticated, interactive visual analytics eliminate the need for static reports. It follows the FDA's 'Good Pharmacovigilance Practices' guidelines and focuses on the end-user perspective. Therefore you can fully assess the risks and benefits associated with a particular drug. You can expect to work with a team of professionals who deliver quality results on-time and within budget.
Signal Intelligence-PV is a turnkey signaling product for post marketing and Clinical Safety. It includes a series of standard analyses populated with data from the internal signaling database typically provided by major safety system vendors.
How Patni Can Help
Patni offers a formal methodology to apply statistical analysis to company and external safety data sources using proprietary templates and data visualization tools.
Our solution offers the choice of three well-known statistical methods, the Multi-Item Gamma Poisson Shrinker (MGPS), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Proportional Reporting Ratio (PRR).
Our approach includes a customized version of DecisionSite from Spotfire, Inc. that creates a simple yet dynamic user interface and rich graphical output. Incorporating data visualization assists companies in translating statistical significance findings into user-friendly graphical output used for clinical assessment and application.
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| Patni’s Drug Safety Offerings: |
| Patni's comprehensive set of drug safety products and services, Intelligent Solutions-PVTM, can help you improve processes, procedures, signaling capabilities, documentation and proactive monitoring. Compliance with Good Pharmacovigilance Practices is essential for a company to demonstrate it has followed the appropriate procedures during development and post-marketing in order to protect patient safety. Patni remains committed to helping our clients bring new products to market and to protect our clients' existing products. |
