Winchester’s Release of CTMS Portal breaks new ground as companies conducting clinical trials can work anywhere and anytime.
WOBURN, MA – March 31, 2008 – Winchester’s newly released CTMS Portal renders instant access for authenticated users anywhere and anytime from a Browser. The early 2008 release is a component of Winchester’s Working Trials Together collaboration model for teams that are conducting clinical trials.
For nearly 15 years, users of Winchester’s clinical trials management system (CTMS) called Pro-tocol Manager have been able to access the system over the Internet using a “thick client.”
Now with Winchester’s latest release, CRAs and Investigators are able to access the system by simply using their Internet Browser.
These field-based users include the Clinical Research As-sociates (CRAs) who monitor clinical trials as well as the Investigative sites that conduct the trial itself. A “thick client” is no longer required.
Sponsors, CROs, Labs, IRBs, ECs, and contract personnel, once authenticated by the system, can also participate in this “role-based” system using their Internet Browser.
Previously, sponsors who hire contract CRAs to monitor the trials were required to install a “thick client” on the contractor’s laptop. Often this installation presented several difficulties and numerous calls to the “helpdesk.” Winchester’s current customer base has been waiting for three years for a break through in web-enabled functionality.
There was good reason for Winchester’s customers planned patience. “I can now set up a com-plete clinical trial in as few as 3 to 4 hours if I have an approved protocol,” says a VP of Clinical Operations at one of Winchester’s west coast customers. “You assign company personnel and contractors to trials in a few minutes time without long installations on laptops and desktops.”
Winchester’s customers that are using this new release of Protocol Manager believe that they are on the “cutting edge” of the next generation of technology that is used to manage the myriad as-pects of clinical trials. According to Mr. Artem Loshak, Product Manager at Winchester, “The Protocol Manager web-enabled version can replace the multiple spreadsheets and local databases that are set up to manage the various aspects and documents involved on a clinical trial.”
But does this new release make financial sense to new customers of Winchester?
Winchester has coupled the new release with an all-new licensing model as well as an optional hosting pricing model allowing new customers to actually pay for the CTMS “by-the-trial.” For smaller Contract Research Organizations (CROs), this low cost of by-the-trial use can be painlessly passed on to the CRO’s trial sponsor. The system provides the CRO such new flexi-bility that the overall cost of the usual “extras” that are requested by sponsors are simple to pro-vide and cost very little.
Sponsors have argued that the benefits to streamlining the clinical trials greatly outweigh the price tag.
Both the hosted and enterprise license versions have been released with significant improve-ments in the interfaces to popular Electronic Data Capture (EDC), Clinical Data Management Systems (CTMS), and Interactive Voice Response Systems (IVRS). According to Michael Re-gentz, the CEO of Winchester, “The new interfaces virtually eliminate the need for entry of the same data to more than one system. The CTMS provides the overall instant, real-time window to the conduct and performance of the clinical trial.”
Mr. Ven Thangaraj, President of Afferenz, a provider of the popular Ac-celliant EDC system, says that, “The interface between the patient data collected by Accelliant and Winchester’s Protocol Manager provides the workflow and basis for quick resolution of que-ries. When the dirty data is detected by Accelliant, Accelliant immediately transmits the fact to Protocol Manager. Protocol Manager alerts the persons responsible to clean the data.”
According to Thangaraj, “This near real-time connection between the EDC and CTMS greatly reduces the backlog of queries in the system. Database lock can be achieved sooner and investi-gator payments are processed with less holdbacks.”
Authenticated users have instant, context-based access to the CTMS from any web-enabled computer on a 24/7 basis.
The new release, Winchester’s Protocol Manager Release 8.0 is available in three stages:
1. The first stage of the Portal, Investigator Sites, was released in early 2007.
2. The second stage, Field-Personnel, will be available during the second calendar quarter of 2008.
3. The final stage with complete access via Internet Browser will be available this summer of 2008.
About Winchester Business Systems
Winchester Business Systems is the leader in providing workflow software business solutions to life sciences industry clients. As an IBM Premier Business Partner, Winchester combines its knowledge of the industry and clinical practices with the application of IBM Lotus products. In addition to Winchester’s several software offerings to life sciences companies, Winchester de-velops custom applications for many clients. Winchester’s clients include Abt Associates Clini-cal Trials, Averion International, Bayer, BIOGEN-IDEC, ClinStar, Cubist Pharmaceuticals, Eli Lilly, Fujifilm Medical Systems, GlaxoSmithKline, Imclone Systems, Johnson & Johnson, MDS Pharma Services, Novartis, Olympus, Pfizer, Philips, Purdue, Sanofi-synthelabo, Stiefel Labora-tories, sigma-tau Pharmaceuticals, and Teva Pharmaceuticals.
Based on a Internet Portal framework, Winchester’s applications extend the information bounda-ries for all of the partners in managing clinical trials. Today, many of the world's smallest to the largest life sciences companies depend on Winchester’s software applications.
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CTMS Internet Portal Renders Anywhere Anytime Access
