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Waltham, Mass.—Phase Forward, aprovider of data management solutions for clinical trials and drug safety,recently took the wraps off a multi-year agreement with Gedeon Richter PLC, aCentral-Eastern European pharmaceutical company with more than 10,000 employeesworldwide.


Gedeon Richter plans to adoptPhase Forward's Clintrial product for its clinical trial data managementactivities.


Martin Young, senior vicepresident of Integration & Product Strategy at Phase Forward, points outthat as clinical research becomes more complex and increasingly global innature, organizations are implementing technology solutions to automate theclinical trial process.


"Clintrial will support GedeonRichter in automating the collection and management of data, improving theefficiency of these processes. Specifically, Clintrial is a software packagethat is being installed in the Gedeon Richter environment," he says. "PhaseForward also assists with the installation, training and validation."


Founded in 1901 and headquarteredin Budapest, Hungary, Gedeon Richter's organization manufactures and marketsgeneric pharmaceutical products for the treatment of a variety of therapy areasincluding gynecology and cardiology. After completing a rigorous competitiveproduct review, Gedeon Richter selected Phase Forward for its comprehensivesolutions and the quality of its services delivery team.


"After an intense review process,Phase Forward's dedicated services organization and proven Clintrial productmade our decision a clear one," says György Németh, medical director of GedeonRichter. "We know that we are collaborating with the premier technologyprovider for clinical trials—and we look forward to garnering the benefitsinherent in greater drug trial efficiencies."


As the pharmaceutical marketbecomes more and more sophisticated, companies increasingly seek best-of-breedsolutions while evaluating issues such as vendor financial strength, stabilityand global support capabilities, Young observes.


"Gedeon Richter is stepping up itsclinical development efforts, and wanted to ensure that it teamed up with apartner with a broad set of solutions, that could support their efforts andscale as they continue to grow and automate other areas of their business,"Young notes.


This agreement marks GedeonRichter's first foray into the use of Phase Forward's Clintrial product,according to Young.


Steve Powell, senior vicepresident of Phase Forward, says Gedeon Richter is an "organization dedicatedto the kind of drug development work that will lead to much-needed new andgeneric therapies."


"It's gratifying to have a companyof Gedeon Richter's reputation choose Phase Forward after such an extensive,thorough review process," he says.


Working with partners like GedeonRichter is important to Phase Forward, Young adds, and the European region is akey market for the company.


"Clintrial has been used for manyyears in Europe by leading organizations, and has successfully supportedsubmissions to many international regulatory agencies, including EMA," Youngpoints out. "This means that a base of professionals who are trained in usingPhase Forward products already exists in the area. By adopting Clintrial,Gedeon Richter is tapping a talent pool with experience in a system that isindustry proven and widely recognized."


Major biotech and pharmaceuticalfirms have increasingly conducted trials on a global basis. Consequently, PhaseForward's products and services have been used in over 10,000 clinical trialsin more than 100 countries, Young says.


"One of the emerging, high-growthareas for clinical trials is certainly CEE, with both local branches ofinternational companies as well as many organizations that have been founded inthe region," Young says. "Phase Forward has a number of clients in EasternEurope, and our base there is growing."


Moreover, Central-Eastern Europe,Young says, is a highly attractive region for running clinical trials.


"With a population of more than300 million, it offers a substantial pool of patients," he adds. "Studiesconducted there have yielded high data quality as well. As a result, sponsororganizations are increasingly incorporating CEE sites into their strategiesfor global studies. In fact, the number of clinical trials initiated in theregion more than tripled from 2002 to 2007. So it is extremely important thatPhase Forward have visibility and strong support for these regions."


Phase Forward-Merck project nets honor


By David Hutton

WALTHAM, Mass.—A joint project with Phase Forward and Merck& Co. has won the 2009 Society for Clinical Data Management (SCDM) DataDriven Innovation Award competition.


The Society for Clinical Data Management's Data DrivenInnovation Award recognizes the year's best advancement in CDM technology orservice resulting from a vendor-sponsor partnership. All exhibiting andsponsoring companies at the SCDM Annual Conference are eligible.


Five finalists competing for the award demonstrated theirprojects to a panel of judges during the SCDM Annual Conference, the largesteducational event in the clinical data management industry.


The winning project and new solution, Direct Data Loader,more efficiently loads external data, such as lab safety and biomarker data. Asa result, external data can be integrated more rapidly and accurately intoMerck's electronic data capture (EDC) system—Phase Forward's InForm solution.


In implementing electronic data capture at client Merck,Phase Forward needed to develop a faster, more accurate data loader to avoidproject delays. The resulting solution, called Direct Data Loader, increasedthe data loading from an estimated 1,000 records per hour to 100,000 and led toan 80 percent drop in errors.


Contest judges gave the Phase Forward project high marks foraddressing a significant clinical data management problem, for innovation andfor the collaboration between the vendor and sponsor.


Bob Weiler, chairman and CEO of Phase Forward, lauded thecreative and collaborative efforts of the Merck/Phase Forward team.


"From its inception, when the team solicited feedback fromstakeholders in the process to define the project, through its development andimplementation, the team focused on its objectives of delivering a highperformance solution while achieving the greatest business benefit possible,"says Weiler.


"SCDM was thrilled with the quantity and quality of entriesin the third annual Data Driven Innovation Award," said Brenda Hoeper,conference co-chair. "We feel privileged to recognize innovations in the CDMdiscipline that have demonstrated evidence of adding value to the clinicaltrial process."


Also considered in the competition were projects fromBioClinica-Amylin, BioClinica-Pozen, Greenway-Nextrials and Medidata-Array.


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