C L I N I C A L D E V E L O P M E N T S O L U T I O N S F O R J A PA N CLINICAL DEVELOPMENT SOLUTIONS F O R J A PA N A2PRA is a joint venture between A2 Healthcare (one of Japan's largest CROs) and PRA Health Sciences (a top 5 global CRO) that delivers both clinical development and Embedded (dispatch worker) solutions across all phases of drug development in Japan. Working with biopharmaceutical companies, A2PRA brings innovative approaches, modern technologies, scientific expertise, and the global reach necessary to meet the demands of a diverse marketplace. A 2 H E A LT H C A R E EXPERTISE A2 HEALTHCARE CORPORATION N o . OF CLINICAL M O NITOR I NG S E RVIC ES* Gl ob a in ord proven track rec ith s eC w RO Enabling Innovation for Value Creation Excellence in Global Clinical Operations Process, Delivery and Execution PEOPLE, nd Embeded Japanese Expertise, Reputation and Capabilites GLOBAL ice a PEOPLE PROCESS TECHNOLOGY PROCESS AND TECHNOLOGY POWERHOUSE lD el op me nt S olutions Market Leadi n gJ ap an e *OVER THE PAST 5 YEARS Gl ca N o . OF CLINICAL STUDIES * in Cli ni 10,000+ 3,500+ Market Leader erv N o . O F EMP L O Y E E S ice Programs lS P R A H E A LT H S C I E N C E S Serv ul * O VE R TH E PA S T 3 YEA R S o l ba ll Fu PRA HEALTH SCIENCES lF 860+ 170+ A2PRA provides sponsors highly-trained project teams, streamlined processes, and cutting-edge technology to support their comprehensive drug development needs. In conjunction with a strong base of Japanese local knowledge, A2PRA executes all projects using PRA SOPs, processes and systems to ensure consistency for global project teams, and programs. ev N o . O F EMP L O Y E E S LOCAL KNOWLEDGE - GLOBAL EXPERIENCE With a sole focus on clinical development in Japan, A2PRA delivers customized solutions for sponsors conducting studies and/or placing sites in Japan. The exclusive PRA – A2 Healthcare collaboration leverages PRA's excellence in global clinical operations processes, delivery, and execution with A2 Healthcare’s local expertise, reputation and capabilities. A2 Healthcare offers unique insights and access to the Japanese market and PRA has a proven record in global, full-service, and Embedded programs. A2PRA’s capabilities in Japan include: New Drug Development Strategic Solutions Post-Marketing Research Medical Affairs Regulatory Affairs Project Management Clinical Operations Patient Recruitment Clinical Monitoring Data Management Biostatistics Functional Services Pharmacovigilance Medical Writing QA Audits 日本の多くの人々がドラッグラグのない時代を待ち望んでおり、その実現のため、 日本の薬事規制や臨床開発環境においては急速なイノベーションが進んでいます。 A2PRAが提供するのは、日本と世界を結ぶ最新かつ最適なソリューションです。 市川 宏司、代表取締役COO HIROSHI ICHIKAWA, President and COO “It’s not enough to be global. A2PRA Project teams harness knowledge of Japanese regulations and customs to make quality decisions that are aligned with study goals.”2 SEAN LEECH, CEO and Representative Director A2PRA 1 “People in Japan are truly craving the era of no drug lag. Innovation of the Japanese regulations and the clinical development environment is taking place very rapidly to achieve this goal. A2PRA provides the most effective and updated solutions to bond Japan and the world.” – HIROSHI ICHIKAWA, President and COO 私たちは“グローバル” であることだけに満足しません。A2PRAのプロジェクトチームは、“グローバル“の豊富な実績・経験と日本の薬事規制や医療習慣に関する知識を融合、高度な戦略決定を可能し、試験を成功へと 導きます。ショーン リーチ、代表取締役CEO 2 The advantage of having a local presence goes deeper than simply already being wherever you may want to go. It’s the level of integration, of familiarity with local people and available resources, combined with the expertise to know what’s needed and how to get it, that gives our clinical development partners an edge. We never forget that every global study is executed locally. Our team harnesses practical knowledge of Japanese regulations, standards of care and cultural customs to maximize the safety and efficiency of every study. We empower our project teams to implement innovative strategies that are specifically designed to connect study insights from around the world and move our clients ahead. Because with each and every study, we’re working with our clients to change lives and make the world a better place. A2PRA provides clinical development and Embedded (dispatch worker) solutions across all phases of biopharmaceutical drug development in Japan. To learn more, please visit us at a2pra.com or email us at [email protected].
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