SAEfetyWorks^® 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.

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).

Drug efficacy tests using EMRs may produce outcomes similar to randomized trials, study indicates (2/10/2009)
UPI (2/11) reports, "U.S. researchers predict national electronic medical records [EMRs] could test drug efficacy on a par with randomized trials," according to a study published in BMJ. For the study, researchers "examined outcomes measured by six previously performed randomized trials and the incidence of stroke, heart attack or death in a group of eight million patients." They found that "there was no difference between database outcomes" using biostatistical methods, and randomized clinical trials in nine out of 17 outcomes," after adjusting "for differences in the database's treated and untreated groups." Still, they caution that "at least 10 years of national data in the United States would be needed before electronic medical record databases could be used to measure treatment efficacy."

Summary of Testimony of Caroline J Loew, Ph.D., PhRMA (5/7/2007)
Assessing the Safety of our Nation's Drug Supply Hearing before the Subcommittee on Health, Committee on Energy and Commerce, United States House of Representatives

Keeping Approvals on Track (8/1/2005)
Applied Clinical Trials Article (August 1,2005)
Registries could strengthen the postapproval safety net—critical in the current cautious environment.

Executive Profile: Jonathan Morris (3/21/2005)
San Diego Business Journal (March 21, 2005)
Jonathan Morris’ background as a trauma surgeon probably prepared him well for the many struggles as chief executive officer of Prosanos Corp.

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

Exenatide and pancreatitis: the importance of reporting negative findings in data mining
Pharmaceutical Medicine (2008; 22(4): 215-219)
The US Food and Drug Administration (FDA) recently published a warning regarding pancreatitis in association with the use of exenatide, an incretin mimetic used for the treatment of patients with diabetes mellitus. We note that this safety issue is not associated with a signal of disproportionate reporting (SDR) in the FDA Adverse Event Reporting System (AERS) database or the World Health Organization (Uppsala Monitoring Centre) Vigibase for any of four data-mining algorithms we tested (proportional reporting ratio, the multi-item gamma-Poisson shrinker, an urn model and the Bayesian Confidence Propagation Neural Network). Exenatide and acute pancreatitis may thus represent a ‘false-negative’ result for disproportionality-based data-mining methodology generally. We evaluate the possibility that this lack of an SDR is caused by the phenomenon known as ‘masking’ (or ‘cloaking’) and reject this hypothesis. While positive findings are understandably more exciting, we discuss why publishing negative findings, such as in this example, is important for placing the capabilities and limitations of drug safety data mining into proper perspective.

Using Data Mining to Predict Safety Actions from FDA Adverse Event Reporting System Data
Drug Information Journal (September, 2007)
Using AERS data 2-3 years following approval, more than half of FDA actions that aoccurred in the next 2-4 years were predicted by data mining, and more than half of the signals detected by data mining corresponded to an FDA action. An appropriate data mining procedure can yield meaningful safety information, often well in advance of regulatory action.

Data Mining in Pharmacovigilance
International Journal of Pharmaceutical Medicine (September, 2007)
This commentary discusses aspects of computational intensity and cost associated with the application of data mining algorithms (DMAs) to spontaneous reporting system data and inllustrate these wiht a reported drug-event association that was the subject of a recent publication in the journal Drug Safety.

Scientific Software Development is not an Oxymoron
PLOS Computational Biology(9/8/2006)
We see important similarities between the way scientists and software engineers approach and attack problems which may provide a general framework for successful scientific software development. Scientists are taught the scientific method from the time they perform their first experiments. Similarly, software engineers are taught about the software development life cycle before they write their first “if” statement. By understanding similarities between these approaches, we can layer some practical methods from the software development life cycle onto computational biology projects to build a solid foundation for success.