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美國Phase Forward
Phase Forward公司是一個(gè)領(lǐng)先的臨床試驗和藥物安全性數據管理解決方案的提供商,2004年5月24日,該公司宣布先靈葆雅研究所已經(jīng)與該公司達成一個(gè)新的技術(shù)協(xié)議,該協(xié)議將歷時(shí)數年,主要是關(guān)于利用InForm電子數據采集(EDC)系統進(jìn)行標準臨床數據管理。做為Phase Forward公司Clintrial臨床數據管理系統(CDMS)的長(cháng)期穩定客戶(hù),先靈葆雅研究所成功的利用該公司InForm軟件降低成本、高效率的收集和分析臨床數據、加速了藥物從I期到III期的流程。最近,該研究所開(kāi)始利用InForm軟件進(jìn)行其第100個(gè)臨床試驗,并獲得許可將該軟件擴展到IV期臨床試驗管理等方面。
先靈葆雅研究所是在2000年開(kāi)始在某些試驗中嘗試使用InForm軟件,到目前為止研究所已經(jīng)在44個(gè)國家進(jìn)行的針對各個(gè)治療領(lǐng)域的100個(gè)臨床中應用該軟件。
Phase Forward公司的產(chǎn)品通過(guò)自動(dòng)處理臨床過(guò)程中的必要元素來(lái)加速產(chǎn)品上市進(jìn)程、降低整體研發(fā)費用、增強現有數據質(zhì)量控制、降低臨床和經(jīng)濟風(fēng)險。目前該公司的產(chǎn)品已經(jīng)在有100多萬(wàn)人參加的1萬(wàn)多個(gè)臨床試驗中應用,涉及到的治療藥物和醫療器械達300多個(gè)。公司客戶(hù)包括制藥公司、生物技術(shù)公司、醫療器械公司、學(xué)校研究所和臨床研究組織等,如阿斯利康、Corixa、Gudant、禮來(lái)、諾華、先靈葆雅等。Phase Forward公司總部在美國麻薩諸塞州的Waltham,在英國、澳大利亞、法國和日本有辦事處。
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.