美国Phase Forward
Phase Forward公司是一个领先的临床试验和药物安全性数据管理解决方案的提供商,2004年5月24日,该公司宣布先灵葆雅研究所已经与该公司达成一个新的技术协议,该协议将历时数年,主要是关于利用InForm电子数据采集(EDC)系统进行标准临床数据管理。做为Phase Forward公司Clintrial临床数据管理系统(CDMS)的长期稳定客户,先灵葆雅研究所成功的利用该公司InForm软件降低成本、高效率的收集和分析临床数据、加速了药物从I期到III期的流程。最近,该研究所开始利用InForm软件进行其第100个临床试验,并获得许可将该软件扩展到IV期临床试验管理等方面。
先灵葆雅研究所是在2000年开始在某些试验中尝试使用InForm软件,到目前为止研究所已经在44个国家进行的针对各个治疗领域的100个临床中应用该软件。
Phase Forward公司的产品通过自动处理临床过程中的必要元素来加速产品上市进程、降低整体研发费用、增强现有数据质量控制、降低临床和经济风险。目前该公司的产品已经在有100多万人参加的1万多个临床试验中应用,涉及到的治疗药物和医疗器械达300多个。公司客户包括制药公司、生物技术公司、医疗器械公司、学校研究所和临床研究组织等,如阿斯利康、Corixa、Gudant、礼来、诺华、先灵葆雅等。Phase Forward公司总部在美国麻萨诸塞州的Waltham,在英国、澳大利亚、法国和日本有办事处。
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. Our award-winning technology and global services are designed to enable life sciences companies of all types and sizes to automate and integrate the management of their entire clinical development process – from study initiation and FDA submission through post-marketing studies. Our products and services have been used in over 10,000 clinical trials involving more than 1,000,000 trial study participants at over 290 life sciences companies, medical device firms, regulatory agencies and public health organizations.
Phase Forward is a publicly held company (NASDAQ: PFWD) with corporate headquarters in Waltham, Massachusetts, international headquarters in Maidenhead, UK and regional offices in the U.S., Japan, France and Australia.
Realizing the Vision
Phase Forward was founded in 1997 by Paul Bleicher, M.D, Ph.D., who had experienced firsthand the complexities involved in developing and conducting paper-based trials – in particular, capturing and managing growing volumes of data. Dr. Bleicher’s vision was to develop technology that would enable organizations to make the shift from paper-based methods to Internet-enabled solutions. His pioneering efforts have contributed significantly to Phase Forward’s evolution from initial concept to its current industry-leading position.
Spearheading the evolution of electronic data capture (EDC) with its industry-leading InForm™ solution, Phase Forward has fundamentally transformed the way clinical data are collected, analyzed and managed. With the acquisition of Lincoln Technologies’ innovative safety management solutions, we have taken a major step in fulfilling our broader mission: to provide the end-to-end solutions our customers need to track and monitor product efficacy and safety, while building their trials more efficiently and cost-effectively.