Welcome!

News Feed Item

General Review of Clinical Trial Environment in Japan 2014

DUBLIN, Ireland, April 23, 2014 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/7wz5xs/general_review_of) has announced the addition of the "General Review of Clinical Trial Environment in Japan 2014" report to their offering.
     (Logo: http://photos.prnewswire.com/prnh/20130307/600769 )


In Japan, companies begin researching and developing pharmaceutical products by looking at novel compounds that show promising activity. Then - once they have determined the effectiveness, properties, movement within the body, and toxicity of certain compounds through non-clinical trials - the researchers can progress to human subjects in clinical trials.

The results are submitted to the Minister of Health, Labour, and Welfare for approval, and if the product is approved, it can be commercialized. There are a variety of tasks that exist when implementing clinical trials, and typically these tasks are carried out by an expert from each relevant field. Pharmaceutical companies traditionally used in-house resources to carry out R&D tasks, but what originally became popular mainly among foreign companies, the outsourcing of such tasks to CRO and other such organizations, has now begun to take hold among domestic companies as well.

For quite a while, and until recently, the number of clinical trials within Japan had stagnated, but this trend has begun to be reversed as government initiatives, beginning in 2003, to improve the clinical trial environment for multinational studies has been successful. A number of issues affecting the clinical trial environment within Japan have been indicated previously, including that trials take too long, that the quality is poor, and that they are too costly.

In order to achieve a breakthrough in this situation, the government (MEXT and MHLW) created the 'National Clinical Trial Revitalization Plan' in April of 2003. In addition, striving to further improve the clinical trial environment in Japan, they created the 'New 5-year Clinical Trial Revitalization Plan' in March of 2007.

There has been a certain amount of success based on these initiatives, including an increasing trend in multinational studies, but improvements in study environments in Asian countries such as China and Korea have been progressing at a speed greater than in Japan, and speaking from a global perspective, it is hard to say that the environment for clinical trials in Japan has been greatly improved.

This report talks about the overview of the environment surrounding clinical trials in Japan. As the local professionals have conducted on-the ground research as well as academic research, readers will see what is really going on in Japan. The report also touches some information about other Asian countries such as Korea, China and Taiwan, readers will be able to see overall trend in Asian region.


Key Topics Covered:

I. Summary

II. Pharmaceutical R&D Flow

III. Definition of Clinical Trial

IV. Main Tasks involved in Clinical Trials

V. Laws and Regulations relating to Clinical Development

VI. Outsourcing to External Organizations

VII. Shift in the Number of Clinical Trials

VIII. Issues

IX. Future Outlook

For more information visit http://www.researchandmarkets.com/research/7wz5xs/general_review_of


Media Contact: Laura Wood , +353-1-481-1716, [email protected]


SOURCE Research and Markets

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...