|By PR Newswire||
|April 22, 2014 03:59 PM EDT||
DUBLIN, April 22, 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:
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
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]
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Nov. 29, 2015 01:00 PM EST Reads: 409
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Nov. 29, 2015 01:00 PM EST Reads: 345
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
Nov. 29, 2015 12:45 PM EST Reads: 413
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Nov. 29, 2015 12:30 PM EST Reads: 419
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 29, 2015 12:00 PM EST Reads: 523
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 29, 2015 11:45 AM EST Reads: 323
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 29, 2015 11:30 AM EST Reads: 272
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
Nov. 29, 2015 10:00 AM EST Reads: 199
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Nov. 29, 2015 09:45 AM EST Reads: 451
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 29, 2015 09:15 AM EST Reads: 343
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 29, 2015 08:45 AM EST Reads: 215
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Nov. 29, 2015 08:00 AM EST Reads: 270
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Nov. 29, 2015 07:00 AM EST Reads: 498
Continuous processes around the development and deployment of applications are both impacted by -- and a benefit to -- the Internet of Things trend. To help better understand the relationship between DevOps and a plethora of new end-devices and data please welcome Gary Gruver, consultant, author and a former IT executive who has led many large-scale IT transformation projects, and John Jeremiah, Technology Evangelist at Hewlett Packard Enterprise (HPE), on Twitter at @j_jeremiah. The discussion...
Nov. 29, 2015 06:45 AM EST Reads: 742
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Nov. 29, 2015 06:00 AM EST Reads: 375