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Phase Forward to Host Fourth Annual International Users Conference

Posted on: Tuesday, 11 October 2005, 12:00 CDT

Phase Forward (NASDAQ: PFWD)--

Who: Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety

What: Fourth Annual International Users Conference

When: Tuesday, October 18, through Wednesday, October 19, 2005

Where: Hyatt Regency Boston, Boston, MA

Currently in its fourth year, Phase Forward will hold its annual International Users Conference on October 18-19 at the Hyatt Regency Boston. The conference will provide an exceptional opportunity for industry experts from leading global life sciences and government organizations - including the Duke Clinical Research Institute, Forest Laboratories, GlaxoSmithKline, Guidant, Harvard Clinical Research Institute, and Lilly - to share practical insight into the successes and challenges of data management for clinical trials and drug safety. Additionally, this year's event will provide an educational forum for Phase Forward and its customers to discuss the recent Lincoln Technologies acquisition and its implications, as well as best practices that can continue to help pharmaceutical, biotechnology, medical device companies, and clinical/academic research organizations streamline their clinical and safety processes.

This year's Users Conference will feature several notable keynotes and informative panel presentations:

-- Ted Chin, vice president of e-data management at GlaxoSmithKline, will deliver a customer keynote titled "EDC Enterprise Adoption," examining the strategic benefits and clinical efficiencies attained through electronic data capture (EDC) adoption. He will share GlaxoSmithKline's experience with the process, and outline the necessary organizational structures, support services, and system and data integration challenges that are part of EDC implementation. Chin will also examine topics related to scaling within the enterprise and the partnership role of the solution provider in achieving enterprise adoption goals.

-- "The Future of Drug Regulation," presented by Eve E. Slater, MD, a member of Phase Forward's Board of Directors and former assistant secretary for health, U.S. Department of Health and Human Services and former senior vice president for clinical and regulatory development at Merck Research Laboratories. Dr. Slater will speak about the future of drug regulation and explore the recent signals at FDA and on Capitol Hill and predict their implication for regulatory change regarding drug development and pharmacovigilance.

-- A panel session entitled "Monitoring and EDC Trials: Is it Evolving, Revolving or Simply Dissolving?" will highlight respective monitoring practices at three companies who use EDC as the primary means of data collection, and highlight the lessons and challenges associated with changing monitoring practices during the adoption phase of EDC. The session will be moderated by Lisa G. Berdan, program director, cardiovascular trials, Duke Clinical Research Institute, and will include speakers Kirby Quintero, senior clinical research associate, Duke Clinical Research Institute, and Tyrus Rorick, R.N., global program manager, Procter & Gamble Pharmaceuticals.

-- "The Growing Challenge of Pharmaceutical Development: Successful R&D Practices for the 21st Century," presented by Kenneth I. Kaitin, Ph.D., director of the Tufts Center for the Study of Drug Development and associate professor of Medicine at Tufts University School of Medicine. Dr. Kaitin will review today's economic and political environment for pharmaceutical innovation and the challenges confronting the research-based pharma industry. Dr. Kaitin will also examine current drug development metrics and the impact of current drug development strategies, and explore new R&D paradigms to improve output and performance.

-- A panel examining Clintrace(TM) 4.0 project planning and customer migration. Bob Leonard, senior director, IT, Harvard Clinical Research Institute, Dr. Gil Price, industry consultant, Drug Safety Alliance, Patricia Snyder, systems manager, clinical drug safety and pharmacovigilance, NPS, and Josephine Matta, associate director, clinical drug safety and pharmacovigilance, NPS, will share their practical knowledge and experiences using Clintrace 4.0 since its introduction one year ago. The panelists will discuss with attendees the various aspects of successful project implementation and their most pressing challenges as part of an informal Q&A session.

-- "Building New Processes to Maximize the Benefits of EDC Adoption," a panel including Marina H. Nillni, corporate team leader, Clinical Trials IS, Dana-Farber Harvard Cancer Center, Christine Tattrie, database development manager, Boston Scientific, and Joseph Zoccoli, senior clinical research project manager, Pfizer Canada, who will discuss how they leveraged Phase Forward's Business Process Optimization (BPO) workshops to more effectively utilize the InForm(TM) EDC solution. This panel session will provide an overview of how BPO has been used by InForm ASP and Enterprise Adoption customers in the areas of remote monitoring, trial development, and change management.

-- Louis A. Morris, Ph. D., will deliver a presentation entitled "Risk Minimization Action Plans," discussing FDA's new guidance for the development of Risk Minimization Action Plans (RiskMAPs), and EMEA's new directives for risk minimization. Dr. Morris is president of Louis A. Morris and Associates, a member of the FDA Drug Safety and Risk Management Advisory Committee, and adjunct associate professor at Temple University School of Pharmacy.

Please visit Phase Forward's Web site to obtain additional information regarding the event at www.phaseforward.com, or contact Phase Forward directly at 888-703-1122. For media inquiries, please contact Brian Gendron of SHIFT Communications at 617-681-1226.

About Phase Forward

Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions in electronic data capture (EDC), clinical data management (CDM), and adverse event reporting (AER) to help pharmaceutical, biotechnology, and medical device companies bring needed drugs and therapies to market faster and more safely. Lincoln Technologies, acquired by Phase Forward in August of 2005, delivers solutions for pharmacovigilance, data standardization, and safety signal detection. The combined companies' products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 220 organizations and regulatory agencies worldwide including: AstraZeneca, Biogen Idec, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, FDA, GlaxoSmithKline, Guidant, MHRA, NIH, Procter & Gamble, Quintiles, Sanofi-Aventis, Schering-Plough Research Institute, and Serono. Additional information about Phase Forward is available at www.phaseforward.com.

Source: Business Wire

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