ECRFPlus Provides Total eSolution

ECRFPlus Achieves Milestone Multimillion Dollar Enterprise Agreement With CRO and Launches e-CRF+(TM):  a CTMS and EDC Web Platform With ECG Analysis and Cardiac Safety Module.

Seattle-based software company provides "total eSolution" to clinical trials industry.

    ISSAQUAH, Wash., Oct. 28 /PRNewswire/ -- ECRFPlus, a software company focused on developing web-based integrated clinical trials management systems (CTMS), announced today it has signed a multi-year enterprise agreement with specialty contract research organization (CRO) and ECG core lab Spacelabs Healthcare Clinical Trial Services, an OSI Systems Company.  Although complete terms of the agreement are not being disclosed, the estimated value including custom software development and integration is in the multi-million dollar range. 

    Spacelabs Healthcare implemented e-CRF+(TM) CTMS as its information backbone to manage critical data for its day-to-day global operations, moving away from piles of paper and going towards state-of-the-art.  Additionally, Spacelabs Healthcare chose ECRFPlus to integrate existing ECG and ambulatory blood pressure (ABP) data collection and analysis systems into a single web-based CTMS + EDC platform.  ECRFPlus granted Spacelabs Healthcare exclusive use of the ECG analysis and cardiac safety module for an initial time period, which ended in early October 2008.   ECRFPlus is now offering the cardiac safety module to the broader clinical trials marketplace through its full enterprise system and flagship product e-CRF+(TM).

    States Ming Lu, founder and CEO of ECRFPlus, "We are very pleased we delivered an 'end-to-end' business and data management solution that makes Spacelabs Healthcare a true 'eCRO' and allows Spacelabs to offer the most advanced 'eSolution' to their clients in the clinical trials industry."
    "We have been thrilled with the e-CRF+(TM) system and the services that have been delivered," said John Carpentier, General Manager, Spacelabs Healthcare Clinical Trial Services.

    e-CRF+(TM) is a web-based 'eClinical' solution suite.  With the ECG module seamlessly integrated, ECRFPlus now offers a turn-key software solution for ECG core labs.  The application also includes electronic signature, reader variability statistics, and an export tool for sending ECG waveform data to the FDA ECG Warehouse in the required HL7 format.  CEO Mr. Lu predicts his company's platform will also be attractive to full-service CROs who are adding their own ECG core lab services to meet the demand for cardiac safety monitoring in clinical trials driven by increasing governmental regulation directed at improving patient safety.  


    The full integration of e-CRF+(TM) offers many advantages over traditional systems, easily handling complex ECG waveform data, as well as ABP and other types of cardiac safety data.  States Mr. Lu, "With our ECG solution, an ECG core lab has end-to-end visibility of their clinical trials.  Literally within hours of being awarded a new project, an ECG core lab can set up a study, configure and ship equipment to sites, then start collecting, analyzing, and reporting data."   Due to lack of integration and manual processes, it generally takes CROs and ECG core labs weeks or even months to start projects. 

    Adds Mr. Lu, "With our 'eClinical' solution, CROs, sponsoring biopharmaceutical companies, and even clinical study sites, can tap into the power and transparency of the ECRFPlus web portal to view and manage data from clinical trials in a single system:  data from CRFs, data from central labs and ECG core labs, even data from patient diaries.  And they can look at the data in real time as it is being collected and analyzed."  The web portal is a value-added feature that ECRFPlus clients can pass on to their clients---sponsoring biopharmaceutical companies---allowing them track the progress of their clinical trials, oversee the performance of the ECG core lab or CRO, keep an eye on enrollment at research sites, and most importantly, watch out for the safety of the patients.  

    Consider the following paradox which is overcome by e-CRF+(TM).   Cardiac safety data is frequently the most critical data for patient safety in clinical trials.  Analyses of these cardiac safety data are used by sponsoring biopharmaceutical companies and governmental regulatory agencies like the FDA to determine how and whether clinical development programs can proceed.  Despite its key role in the lifecycle of a clinical development program, however, sponsors may not get access to cardiac safety data until months after data has been collected and analyzed by the ECG core lab.   Not so with e-CRF+(TM). 

    Since it was first launched in 2006, e-CRF+(TM) has been used to manage hundreds of millions of data points captured via EDC and has also been used to track clinical trial supplies and medical equipment  on 5 of 6 continents.  The e-CRF+(TM) system has also successfully undergone validation audits by major pharmaceutical companies.
 
    About ECRFPlus, Inc.
    ECRFPlus, Inc. (http://www.ecrfplus.com) is a Seattle-based, privately owned software and 'eClinical' solution provider, offering an array of fully-integrated products including CTMS, EDC, eCRF Designer, ECG analysis, and Clinical Supply & Logistics modules on a single web platform.  ECRFPlus is dedicated to providing custom and innovative 'eClinical' solutions to serve biopharmaceutical and medical device companies, CROs, pharmacology units, and Academic Research Centers across the globe.  The company also helps companies seeking to integrate clinical applications and healthcare IT into a clinical trials management system (CTMS).  The company is focused on the emerging needs of the clinical trials industry which demand expertise, flexibility, and leading-edge technologies.  ECRFPlus products and services help clients complete studies quickly and cost-effectively, while ensuring the highest level of regulatory compliance and scientific integrity. 
    For inquiries about ECRFPlus, please contact Mr. Ming Lu at 425-837-0930 or email minglu@ecrfplus.com . 
 
    About Spacelabs Healthcare, Inc.
    Spacelabs Healthcare, Inc. (http://www.spacelabshealthcare.com) is an international developer, manufacturer and distributor of medical equipment and services including solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories selling to hospitals, clinics and physician offices. Additionally, the Company provides centralized cardiac safety and diagnostic services
(QT Studies, ECG, Holter, ABP, and Event Monitoring) to biopharmaceutical companies undertaking clinical trials. The Company employs approximately 1,100 personnel in its offices located in the United States, UK, Canada, France, Germany, Finland, India and Singapore.
 
SOURCE  ECRFPlus