Emergo Group to Provide Full Clinical Trial Support Services in Japan

Emergo Group now offers comprehensive clinical trial management and support in Japan through partnership with NTT Data Group.

2011-03-09

TOKYO, JAPAN, March 09, 2011 (Press-News.org) Emergo Group, a leading medical device quality assurance and regulatory affairs consulting firm, has formed a strategic partnership with Data Pharma Co. Ltd. to provide full clinical trial management services in Japan. Data Pharma is the Clinical Research Organization (CRO) subsidiary of Tokyo-based NTT Data Group.

Emergo Group's office in Tokyo, Emergo Japan K.K., will offer comprehensive clinical trial management services to assist medical device manufacturers. The move comes in response to a growing need for medical device manufacturers to demonstrate the efficacy of their products through clinical trials conducted in Japan.

Michiharu Miyahara, President and CEO of Emergo Japan K.K. notes: "The Japanese government has a strategy to drive growth in the life sciences industry, but this has been challenging due to the complexity of conducting clinical trials in Japan which are sometimes needed to obtain regulatory approval. There are very few consultancies specializing in medical device clinical trials in Japan so we are addressing this growing need. Our team is eager to start helping manufacturers conduct clinical trials for their products prior to commercialization in Japan."

Japan's Pharmaceutical and Medical Devices Agency (PMDA) requires clinical trials in cases where a medical device's safety and efficacy cannot be evaluated using existing literature or non-clinical evidence, as well as for high-risk devices. The PMDA sometimes accepts clinical trial results obtained outside Japan, provided those results conform to the country's equivalency standards.

Emergo Japan and Data Pharma provide clinical trial management consulting and CRO-related services respectively for both foreign and Japanese medical device clients.

About Emergo Group
Emergo Group is a medical device regulatory consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distribution consulting. Emergo Group has more than 1500 clients manufacturing a wide range of medical devices and IVDs. Offices worldwide. www.emergogroup.com

About Data Pharma
Data Pharma, a member of NTT Data Group, is a contract research organization supporting more than 100 health care institutions across Japan. Supporting both medical device and pharmaceutical clinical trials, Data Pharma also offers data management and statistical analysis services.

ELSE PRESS RELEASES FROM THIS DATE:

Sumitomo Electric and Ixia to Demonstrate 40 GbE CFP Transceiver for Distances Up To 40 km at OFC 2011

2011-03-09

Sumitomo Electric Industries, Ltd., a leading global provider of advanced optical solutions, and Ixia, a major provider of converged IP network test solutions, will be conducting a joint 40 Gigabit Ethernet (40 GbE) CFP demonstration in Sumitomo Electric's booth (1624) during the OFC/NFOEC 2011. The demonstration will showcase Sumitomo Electric's 40 GbE CFP optical transceiver for 40 km reach and Ixia's "K2" high-speed Ethernet interfaces. "This demonstration will prove the viability of extended 40 GbE links using 1310 nm sources," said Ichiro Kono, general manager of ...

The First BlackBerry-Outlook GTD Software Solution Adds Email Organization, Touchscreen Navigation and More

2011-03-09

The Viira Outlook Suite is the first and only GTD software application to bring together the power of Microsoft Outlook and a BlackBerry smartphone into a personal productivity solution that helps users stay organized and get things done from wherever they are. Based on David Allen's bestselling Getting Things Done, the Viira Outlook Suite applies the power and reliability of the BlackBerry Enterprise Server to provide near-instant synchronization of to-dos, projects, priorities and commitments between Microsoft Outlook and a BlackBerry device. The Viira Outlook Suite ...

Elderly see pedestrians half as often as younger drivers, according to Ben-Gurion U. researchers

2011-03-08

BEER-SHEVA, ISRAEL, March 7, 2011 – Elderly drivers are half as likely to see pedestrians on the sidewalk due to a limited field of view, and compensate in part by driving more slowly, according to a study by Ben-Gurion University of the Negev (BGU) researchers. In the online edition of Accident Analysis and Prevention, the study compared reaction times and perception of pedestrians as hazards between experienced elderly and non-elderly drivers. The study was conducted in response to an increasing number of pedestrian-related accidents among elderly drivers. Age 65 ...

RA sufferers armed with kitchen safety tool

2011-03-08

His design has earnt a spot on the first-round shortlist of one of the world's most prestigious design competitions - the Australian Design Award/James Dyson Award. Twenty-four-year-old Ching-Hao (Howard) Hsu, who graduated with a Bachelor of Design (Industrial Design) at the end of 2010, designed the 'arthritis handle' after observing several sufferers of rheumatoid arthritis performing cooking tasks in their own kitchens. RA is a chronic disease affecting one percent of the population - about 500,000 Australians. It involves inflammation of the joints, which can lead ...

Flipping a switch on neuron activity

2011-03-08

WASHINGTON, D.C. (March 7, 2011) -- All our daily activities, from driving to work to solving a crossword puzzle, depend on signals carried along the body's vast network of neurons. Propagation of these signals is, in turn, dependent on myriad small molecules within nerve cells -- receptors, ion channels, and transmitters -- turning on and off in complex cascades. Until recently, the study of these molecules in real time has not been possible, but researchers at the University of California at Berkeley and the University of Munich have attached light-sensing modules to ...

Body mass index and risk of death in Chinese population

2011-03-08

Chinese people with a body mass index (BMI) of 24-25.9 had the lowest risk of death, according to a study published in CMAJ (Canadian Medical Association Journal) (pre-embargo link only) http://www.cmaj.ca/embargo/cmaj101303.pdf Obesity has increased significantly across the globe and the World Health Organization (WHO) estimates that about 2.3 billion adults will be overweight and more than 700 million will be obese by 2015. Overweight and obesity are associated with increased risks of heart disease, diabetes, cancer and other chronic diseases. As white populations ...

Dementia risk is higher in people with both stroke and irregular heartbeat

2011-03-08

Stroke patients who also suffer from an irregular heartbeat are at double the risk of developing dementia, according to a new study by the University of East Anglia (UEA). Published tomorrow in the journal Neurology, the findings show that stroke survivors with an irregular heartbeat – or atrial fibrillation - are 2.4 times more likely to develop dementia than stroke survivors without the heart condition. The researchers analysed 15 studies with more than 45,000 participants and an average age of 72. They compared patients with and without atrial fibrillation, and ...

Stroke survivors with irregular heartbeat may have higher risk of dementia

2011-03-08

ST. PAUL, Minn. – Stroke survivors who have an irregular heartbeat called atrial fibrillation may be at higher risk of developing dementia than stroke survivors who do not have the heart condition, according to research published in the March 8, 2011, print issue of Neurology®, the medical journal of the American Academy of Neurology. Atrial fibrillation affects more than two million Americans, and it is more common as people age. About 15 percent of strokes occur in people with atrial fibrillation. The heart's two upper chambers do not beat effectively in the condition, ...

Mediterranean diet: A heart-healthy plan for life

2011-03-08

The Mediterranean diet has proven beneficial effects not only regarding metabolic syndrome, but also on its individual components including waist circumference, HDL-cholesterol levels, triglycerides levels, blood pressure levels and glucose metabolism, according to a new study published in the March 15, 2011, issue of the Journal of the American College of Cardiology. The study is a meta-analysis, including results of 50 studies on the Mediterranean diet, with an overall studied population of about half a million subjects. "The prevalence of the metabolic syndrome is ...

Diabetes belt identified in southern United States

2011-03-08

San Diego, CA, March 8, 2011 – In the 1960s, a group of U.S. states with high age-adjusted stroke mortality defined a "stroke belt." Until recently, geographic patterns of diabetes had not been specifically characterized in the same manner. In an article published in the April 2011 issue of the American Journal of Preventive Medicine, researchers were able to identify clustered high prevalence areas, or a "diabetes belt" of 644 counties in 15 mostly southeastern states using data compiled for the first time of estimates of the prevalence of diagnosed diabetes for every ...

Emergo Group to Provide Full Clinical Trial Support Services in Japan

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: