ECG DAta And tools
CLINICAL DATABASE
Each ECG file is associated with clinical information. This information are stored in SAS or Excel files and they are automatically downloaded to the client side when a user access a specific database. These files are accessible from the THEW Client Application. To learn how to access this data. >More
THEW CLIENT APPLICATION
This last week of August, the beta-version of the THEW Client Application (CA) has been released to a selected number of sites in US and in Europe leading to an international effort for the validation process of our software. In addition, the THEW CA was released to the FDA and it is currently evaluated by individuals from the CDER and the CDRH at the FDA Campus in Silver Spring, MD. In addition, the THEW CA has been installed in academic centers in Italy, France, Czech Republic, and Finland.
A preview of the THEW Client Application and its features is available here .
[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here.
[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here.
[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here
[5/6/2009] FDA website Existing Partnerships FDA’s Public-Private Partnership Program: THEW
[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com.>here
[12/15/2009] Members: University of California and the San Francisco Campus (UCSF) has joined the Telemetric and Holter ECG Warehouse and its Center for Quantitative and Cardiac Safety. The collaborative arrangement has been triggered by the School of Nursing. UCSF School of Nursing was #1 in NIH research funding from 2003 to 2008 and was top ranked in US News America’s best Graduate School for 2007.
[11/16/2009] Technology: The THEW announces the release of its HL7 XML extraction tool. The THEW client application allows for ECG to be exported in HL7 XML ECGs, an ECG format broadly used in drug safety trials.
[05/27/2008] FDA: Dr. J. Woodcock (Director, CDER-FDA) and Dr. Norman Stockbridge (Director for the Division of Cardiovascular and Renal Products, CDER-FDA) signed a Letter of Agreement officially starting the partnership between the FDA and University of Rochester for the THEW initiative. More...
[05/27/2008]: "THEW Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA. More...