ProSanos helps our partners gain a better understanding of the potential risks associated with a particular product, class of products, or therapeutic area. Our unique pharmacovigilance products and services assist in identifying and evaluating evidence of risk found within disparate data sources, including spontaneous reporting system (SRS) data and observational data sources such as healthcare claims data and electronic health records. We provide the following Safety and Risk Management Products and Services: CLÆRITY®: easy-to-use, web-based software for the investigation and management of potential safety signals in private and public spontaneous reporting system databases (learn more). CLÆRITY products and services include:
Observational Pharmacovigilance: web-based software and underlying analysis methodology enabling routine, proactive safety signal detection and evaluation utilizing large, disparate, observational databases (learn more). Observational Pharmacovigilance products and services include:
PV Plan: ProSanos' PV Plan software enables you to create and manage a Pharmacovigilance Plan, in accordance with the EU Risk Management Plan Template (EU-RMP). With PV Plan, you can document identified and potential safety concerns for a product, and track actions, accountable persons, status, and related milestones for characterizing those concerns and identifying additional concerns. The web based platform makes it easy for diverse and/or geographically separate teams to collaborate and share information through the product lifecycle, and to manage the Pharmacovigilance process. PV Plan enables you to document all Safety Concerns for a product, not just signals generated post product launch or by data mining. Management and QP views allow summary Safety Concern visibility. Post-approval safety studies and registries: Implementation of post-approval safety studies and registries for active safety surveillance (learn more) Other Services Offered by ProSanos Observational Pharmacovigilance Registries & Observational Studies Health Outcomes Analysis & Publications |
Case Studies
To illustrate the technology that underlies CLÆRITY, ProSanos initiated the PVmap of the Week program. This program demonstrates applications of our technologies to some topical questions in drug safety, such as: Pergolide & Risk of Cardiac Valve Regurgitation (1/7/2007) Proton Pump Inhibitors & Falls (1/14/2007) Abnormal Sleep-Related Events and Sedative-Hypnotic Products (3/25/2007) As part of this series, a different topic of current interest within the industry is examined periodically. (learn more )
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