SÆfetyWorks^® Captures Prestigious
Award at Industry Gathering in Boston (4/29/2009)
Harrisburg, PA – April 29, 2009. ProSanos Corporation is pleased to announce that SÆfetyWorks^®, a web-based, semi-automated software system that helps scientists more quickly spot and measure the strength of associations between a drug and a medical condition found within large electronic healthcare databases, was recognized by Bio-IT World during the fifth annual Best Practices Awards program last evening in Boston MA.

ProSanos Corporation Releases New Software System to Improve Patient Safety Via Surveillance and Analysis of Claims and Electronic Health Records (8/12/2008)
ProSanos Corporation announced today the release of SÆfetyWorks^®, a web-based, semi-automated software system that can help scientists more quickly spot and measure the strength of associations between a drug and a medical condition found within large electronic healthcare databases. SÆfetyWorks^® resulted from a partnership between GlaxoSmithKline plc (GSK) and ProSanos. Several years in development, it is now available to all pharmacovigilance professionals.

ProSanos Corporation Announces the Release of CLÆRITY^® for the Evaluation of Drug Safety (6/19/2007)
CLÆRITY^® can be used to explore questions about the safety of a particular drug, class of drugs, or therapeutic area
Harrisburg, PA - June 19, 2007. ProSanos Corporation, specializing in the capture, integration, and analysis of healthcare-related data, has announced the launch of CLÆRITY, a next-generation software product that can be used to explore questions about the safety of a particular drug, class of drugs, or therapeutic area.

ProSanos VP of Research, Alan Hochberg, Appointed to Chair DIA SIAC (6/19/2007)
Alan Hochberg, ProSanos’ Vice President of Research was recently elected as the new North American chair for the Drug Information Association’s Statistics SIAC.

ProSanos Corporation Joins BioIT Alliance (11/14/2006)
ProSanos Corporation, specialists in the capture, integration, and analysis of healthcare-related data, is pleased to announce that it has joined Microsoft Corporation and an array of other leading organizations in a collaborative effort known as the BioIT Alliance.

The December 2009 OMOP Quarterly Newsletter is now available at omop.fnih.org (1/21/2010)
The Observational Medical Outcomes Partnership has released their December 2009 Newsletter. Topics include, among other things, a review of the 2009 OMOP Symposium held Nov. 12, 2009 in Bethesda, a description of the Observational Analysis Methods Research Project, and an interview with OMOP Advisory Board Member Dr. David Page from the University of Wisconsin-Madison. ProSanos is an active partner in the Observational Analysis Methods Research Project.

ProSanos featured in Insight Pharma Reports: Data Mining in Drug Development and Translational Medicine (10/16/2009)
The biopharmaceutical industry is grappling not only with sheer data volume but with the ability of researchers to extract information through identification and contextual analysis of those data that are relevant to a particular set of investigations. This report examines techniques, technology, and software used in life science data mining; data mining for early preclinical safety assessments; fata mining in clinical trials; data mining in pharmacovigilance; and business models and solutions in drug development bioinformatics.

OMOP Releases Medical Data Simulator developed by ProSanos (9/23/2009)
The Observational Medical Dataset Simulator (OSIM) is an open-source software application that allows users to create simulated datasets that conform to the OMOP Common Data Model. The procedure is being used to create simulated datasets to support OMOP's central methods development activities, as well as to facilitate the OMOP Cup methods competition.

Safety Works at GlaxoSmithKline (7/20/2009)
Best Practices Winner: GlaxoSmithKline
Project: SÆfetyWorks^®
Category: Translational and Personalized Medicine
Nominated by: ProSanos Corp.

REGISTRAT-MAPI Becomes Industry's Largest Global Late Phase CRO (6/17/2009)
REGISTRAT-MAPI unites into a single company the premier late phase clinical research organizations in the US (REGISTRAT) and Europe (MAPI/PHIMAP). This combination is a powerful new resource focused solely on meeting the increasing demand to design and conduct global registries, observational and epidemiological studies, and Risk Management Programs (REMS and EU-RMPs).

Influence of MedDRA hierarchy on pharmacovigilance data mining results
IJMI Volume 78, Issue 12, Pages e97-e103 (December 2009)
Use of HLT and SMQ groupings can improve the percentage of unlabeled supported SDRs in data mining results. The trade-off for this gain is the medically less-specific language of HLTs and SMQs compared to PTs, and the need for the added step in data mining of examining the component PTs of each HLT or SMQ that results in a signal of disproportionate reporting.

Performance of a Semi-Automated Process for Estimation of Risk using Observational Databases
Poster Presentation at ICPE 2009 Annual Meeting in Providence, RI

Background
Proactive safety surveillance is anticipated to generate many new potential drug safety signals. SÆfetyWorks^® v2.3 (SW), a semi-automated application using large observational databases, generates an incidence rate ratio (IRR) and 95% confidence interval (CI) for potential associations between a drug and a medical condition derived from a retrospective cohort design ("risk estimation"). SW allows users to select parameters important to statistical modeling design and suggests covariates for propensity score (PS) modeling and confounders for Poisson regression.

Objectives
To evaluate the performance of SW by replicating published studies using retrospective cohort or case-control designs to address drug and medical condition associations and comparing the IRR and CI generated by SW to the results in the respective published study.

Performance of Screening Multiple Observational Databases for Active Drug Safety Surveillance
Poster Presentation at ICPE 2009 Annual Meeting in Providence, RI

Background
Recent calls have been made to establish a national active drug safety surveillance system that leverages observational data, including administrative claims and electronic health records, to monitor and evaluate potential safety issues of medicines. Several initiatives aim to inform efforts in this area. However, the development and evaluation of appropriate statistical methods for observational data have not yet been comprehensively studied to assess the impact on current pharmacovigilance practice.

Objective
To evaluate the performance of alternative screening methods for identifying drug-condition associations across two disparate observational databases.

Risk Estimation Analytical Methods
White Paper
This document describes risk estimation, the underlying method used in SAEfetyWorks to calculate an Incidence Rate Ratio (IRR) which compares the rates of a particular adverse event between two drugs, known as the target and the comparator. Some statistics associated with the IRR, such as confidence limits, are also computed. Propensity score adjustment is employed to minimize the impact of confounding clinical and demographic factors on the calculated IRR.

Drug-versus-Drug Adverse Event Rate Comparisons: A Pilot Study Based on Data from the US FDA Adverse Event Reporting System
Drug Safety 2009, Volume 32, Issue 2
A number of published studies compare adverse event rates for drugs on the basis of reports in the US FDA Adverse Event Reporting System (AERS). While the AERS data have the advantage of timely availability and a large capture population, the database is subject to many significant biases and lacks complete patient information that would allow for correction of those biases.

Abstract