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July 2010 InCROM EUROPE Achievements Updates

Our achievements in Europe have been updated.

InCROM EUROPE Achievements

Jun 2010 InCROM CHINA in Guangzhou

InCROM CHINA’s Guangzhou office is officially opened. We’re located inside the Bank of America Plaza in the Liwan District that has been one of the most active business zones in Guangdong Province. Guangzhou, being the capital of Guangdong, is one of the most populous metropolitan cities in China. Its well developed transport network enables easy land access by clients based in many southern parts of China, including the special administrative region of Hong Kong. At present, InCROM CHINA is affiliated with 115 SFDA-approved medical institutions across the country (approx.275 in total), 8 of which are in Guangzhou (listed below).

Address: InCROM CHINA Guangzhou Office Bank of America Plaza Room 1106A – 555 Renmin Zhong Road Guangzhou 510180 CHINA Tel: +86(0)20-8109-4031

Jun 2010 InCROM CHINA Achievements Updates

Our achievements in China have been updated.

InCROM CHINA Achievements

May 2010 InCROM EUROPE AT EXPLORATORY CLINICAL DEVELOPMENT WORLD

InCROM Europe exhibited at the Exploratory Clinical Development World conference held in London from May 18th to 21st. 175 delegates attended from large multinational pharmaceutical to small biotech companies to hear about new developments in the conduct of Phase I trials. At the conference we placed a lot of emphasis on our ethnic Asian bridging PK study capabilities, which proved to be of great interest to delegates, attracting a lot of attention. It was a very useful conference to further increase delegates’ awareness of InCROM Europe / ICRU and our bridging PK study capabilities, and for us to keep updated on industry developments.

May 2010 Achievements & Volunteer Recruitment Updates

Our achievements and volunteer panel in Japan have been updated.

InCROM JAPAN Achievements
InCROM JAPAN Recruitment

May 2010 Making a Social Contribution

InCROM GROUP orignated from the beatuiful countryside of Nishiwaki in Japan. Due to our business growth and need to advance in the industry, our business centers were relocated to the metropolitan areas of Tokyo and Osaka years ago.

The vast area where our work was concentrated had been converted to rice fields. Since then, our Nishiwaki team has been dedicating their time to growing rice, which is consumed by subjects participating in our in-patient trials.

With a recent surplus of rice, we decided to put it into good use, leading to the production of our in-house Japanese wine named ‘Kingyoku®’(can be loosely translated as ‘Drops of Gold’), which is the same brandname for the wine produced in the 1860’s by the ancesters of our founder, Dr. Kanada (Sr.).

The product is not for sale and will be presented to employees’ families. We merely consider the project a way to contribute positively to the environment and agricultural sustainability.

April 2010 Updates on the Clinical Trials Simulation Program

The Clinical Trials Simulation Program launched early this year with the intention to help deepen the understanding of professionals in the pharmaceutical industry, is going well. Six pharmaceutical representatives who participated in the program spent two days (April 13-14) at OPHAC Hospital. They were keenly involved every step of the way. A few mentioned that not knowing what to expect, they were a little nervous at first. As soon as they started interacting with the investigators and other clinical staff, the tension quickly dissipated.

We strongly believe in the merits of this program and that the program serves as a platform for valuable information and opinion exchange between pharmaceutical companies and study sites. We appreiciate all feedback and look forward to receiving the next group of volunteers!

April 2010 Welcome New Employees!

A formal welcoming ceremony followed by a welcome party were held for the newest addition to our group. The new employees will undergo various indepth training sessions over the next four weeks.

Feb 2010 Dear Volunteers, thank you always!

Our volunteer panel wouldn’t have grown continuously without people’s belief in the significance of clinical research and drug development. For over 35 years, we have been having a proven track record of successful, reliable recruitment largely contributed by the volunteers. As a token of our appreciation, a few pieces of character stationery has been created. It is hoped that the signature character, Shennong, who is believed to be the father of drug development in Japan and China, will reiterate the importance of our business and their paritcipation.

Feb 2010 'Secrets to a Good Relationship' published by ICT

Brendan Ellis, our BD Manager at InCROM Europe, has an article titled ‘Secrets to a Good Relationship’ published in the International Clinical Trials (ICT), a well recognized journal specifically produced to provide global coverage of topics pertinent to the industry.

Please click for a viewing of the file.

Jan 2010 2010 IRB Schedules

for our clinical network in Japan have been updated.

Jan 2010 InCROM Group Achievement Updates

At present, our group achievements have surpassed 1,500 projects, with over 1,100 Phase I clinical studies and a good number of later phase including PK and patient studies, conducted in Japan. In the UK, InCROM EUROPE / ICRU has successfully completed a number of projects involving both Caucasians and Japanese subjects, as well as RA studies. The latest achievements of InCROM CHINA include two oncology studies, and projects in other top selling therapeutic areas are being scheduled.

Dec 2009 Clinical Trials Simulation Program offered at OPHAC Hospital

To help deepen the understanding of professionals in the pharamceutical industry, InCROM Japan has developed a Clinical Trials Simulation Program to be offered at OPHAC Hospital from January 2010. The innovative program will provide the keen industry personnels firsthand, simulated experience with Phase I clinical trials (overnight stays possible).
Click here for details (Japanese). For enquires, please contact our Business Development Department at +81(0)6-6192-0002.
Please specify if assistance in English is preferred.

Sep 2009 New Homepages

Our homepages have been redesigned. In addition, a homepage dedicated to recruitment for Caucasian studies is now available.

• InCROM GROUP
• InCROM JAPAN
• InCROM EUROPE
• InCROM CHINA
• Medical Volunteer Centre (MVC)

Mar 2009 ICRU - Standard & Supplementary Accreditation Granted

We announce with great pride and pleasure that ICRU (InCROM Clinical Research Unit), our clinical facility in London, England, has been granted MHRA (Medicines and Healthcare products Regulatory Agency) Standard & Supplementary accreditation for Phase I Clinical Trials Units as of March 25, 2009.

According to the MHRA, a clinical research facility with standard accreditation can carry out all Phase I trials other than FIH (First in Human) trials with risk factors that would require review by the EAG (Expert Advisory Group); and a facility with supplementary accreditation can carry out trials with compounds at all levels of risk including those that require review of risk factors by the EAG.

The voluntary accreditation scheme was created as a reactive measure to the TGN1412 incident in March 2006, where six subjects became seriously ill and were admitted to intensive care. To be granted the accreditation means that the clinical facility has successfully passed on-site inspections of the facility, procedures and staff training and experience, and has met all the safety requirements specified by the MHRA.
ICRU started running its first clinical trials in November 2007 and has achieved accreditation status in just 16 months. It is the seventh unit to receive accreditation under the scheme.
For details on the accreditation scheme:
http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON2033112

Dec 2008 Luncheon Seminar at the 29th Annual Meeting of Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) Meeting

The 29th Annual Meeting of Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) Meeting will be held in Keio Plaza Hotel Tokyo from December 4-6. The theme this year is ‘From early phase drug development to large-scale clinical trials’. It’s an honor to have Dr. Yasuko Owada, one of our clinical research experts at InCROM Europe, to be the speaker at the luncheon seminar on December 4. Dr. Owada will be presenting some valuable information on the Phase I Accreditation Scheme, newly developed and launched in the UK as a reactive strategy corresponding to the safety concerns raised by the public.

Date/Time: 4th December (Thursday) 12:15 - 13:15
Venue: Eminence Hall, 5/F, Keio Plaza Hotel Tokyo
http://www.keioplaza.com/banquet/eminence.html

For enquiries, please contact japan-info@incrom.com.

Feb 2008 New Address of InCROM China's Head Office

Room 603, Building C, Hi-Tech Building
900 Yishan Road, Shanghai, China 200233
Tel: (+86) 21-5423-4291
Fax: (+86) 21-5423-4292

To accommodate our rapidly growing business in China, InCROM China's head office has been relocated into the Hi-Tech Building on Yishan Road, easily accessible via the Shanghai Metro (50m south of Caohejing Hi-Tech Park Station). The new office is twice the size of the previous office, thus providing more space and comfort for both clients and staff.

Dec 2007 New Offices in China

InCROM CHINA (Shanghai, China) is affiliated with more than a quarter (58 as of October 2007) of all SFDA-approved medical institutions and has been conducting clinical studies at those sites. The trial sites are at many locations (Shanghai, Beijing, Chongqing, Guangzhou, Nanjin, Tianjin, Zhejiang, Anhui, Jiangxi, Sichuan, Henan, Shandong, Shanxi, Hubei, Jilin, and Heilongjiang) accounting for about half of China's major regions. It is a rather overwhelming task to manage all those areas from just the Shanghai Business Office. In order to allow proper management and smooth operations within InCROM China's vast network, the Beijing office was established in October, and the Chongqing office as well as the Guangzhou office are being set up currently.

InCROM CHINA's Affiliated Network
Click to open new large window for easy to read charactors

Dec 2007 Privacy Mark

Highly aware of the fact that we are in a business concerning many people's personal information, we feel it an important social responsibility to place personal information protection on top of our priority. Since 18th of July 2007, InCROM Japan has been carrying a permit for the use of Privacy Mark from Japan Information Processing Development Corporation (JIPDEC).

The Privacy Mark system is harmonized with the JIS specification (JIS Q15001 Requirements for the Protection of Privacy Management System), which qualifies those companies who adopt an appropriate system for the protection of personal information. The system bestows the Privacy Mark indicating such status and approval to use the granted Privacy Mark for business activities. As an organization highly involved in the handling of medical records for clinical study subjects, we consider the protection of personal information an important social responsibility. From now onward, we strive to emphasize the paramount importance of protection of personal information, and any personal information shall be handled in strict accordance with the policy.

Dec 2007 Seminar titled 'Current Circumstances Surrounding Microdose Studies and Exploratory INDs' at The 112th Japanese Pharmacological Society (JPS) Meeting

The 112th Japanese Pharmacological Society Meeting in Kinki District was held at Senri Life Science Center in Toyonaka City, Osaka on the Friday of November 16. A Luncheon Seminar was held under the auspices of the JPS and InCROM. A speaker from InCROM, Dr. Hiroshi Mayahara, gave a talk on "Current Circumstances Surrounding Microdose Studies and Exploratory INDs." A total of almost 350 researchers and students attendeded this meeting and shared information pertaining to basic as well as clinical pharmacology.

Dec 2007 Luncheon Seminar titled 'Globalization of Clinical Studies - A Solution to the Drug Lag' at The 28th Annual Meeting of Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) Meeting

The 28th Annual Meeting of Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) Meeting was held at Tochigi Prefectural Cultural Center and Utsunomiya Tobu Grande Hotel from November 28 to 30. At the same meeting, a Luncheon Seminar was held under the auspices of the JSCPT and InCROM on the first day. A lecture entitled "Globalization of Clinical Studies － A Solution to the Drug Lag" － was presented by Mr. Kitaoka Shinsuke, the CEO of a UK-based company BioGemini. The seminar was held as the 20th InCROM Forum and was chaired by Dr. Itoh Tadao (MD, PhD), a professor emeritus at Tottori University and a director of Medical Corporation Heishinkai OCROM Clinic. At the Meeting, we also had a booth to exhibit our business activities.

Dec 2007 DreamCIS (Seoul, Korea) - our Asian alliance

InCROM Group's global reach includes its subsidiaries (InCROM Europe, InCROM China and InCROM Hong Kong), its group-owned / core affiliated clinical trial facilities (ICRU in London, OPHAC Hospital in Osaka, OCROM Clinic in Osaka, and ToCROM Clinic in Tokyo), CRO Rabiton in Osaka, and many other clinical and business alliances globally.

The latest business alliance, DreamCIS Inc., is a leading CRO in Korea affiliated with many clinical research facilities including the best public and private university hospitals where sponsor-initiated clinical trials are also conducted. The collaboration will allow any multinational projects including Korea and Japan to be set up with high speed and cost efficiency.

Sep 2007 Koganeibashi Clinic is officially opened!

As of September 5, InCROM Japan's newest clinical affiliate, Koganeibashi Clinic in Tokyo, is officially opened. The 67 parties representing 35 companies who visited us at the Open-House were all impressed by the 19-bed facility custom-designed for clinical research.

Prospective visitors please contact us at japan-info@incrom.com.

Sep 2007 InCROM China's updates

InCROM China's business has been progressing at a rate of 1 PROTOCOL / MONTH. Moreover, the clinical affiliated network has increased from 51 to 53, making it a network covering 16 provinces in China.

Sep 2007 What's new in China?

SFDA Order No. 28 has been revised in July this year and will be effective from October 1. Some of the key contents modified involve aspects that will certainly strengthen the Chinese pharmaceutical market. For example: 1) drug safety requirements will be made more strict; 2) review and approval standards will be improved to avoid low-level registrations; 3) drug innovation will be encouraged; 4) supervision system will be restructured to eliminate 'under table deals'.

Jul 2007 Open House of Koganeibashi Clinic in Tokyo (Aug 27-31)

InCROM Japan’s newest clinical affiliate, Koganeibashi Clinic in Tokyo, will be opened in Sep 2007. The 19-bed facility will be a general practice as well as a clinical research unit fully supported by InCROM Group and Iryo Fukushi Research Institute Inc. ToCROM Clinic’s IRB will serve as an external IRB for Koganeibashi Clinic and volunteer recruitment will be provided by Iryo Fukushi Research Institute Inc.

Prospective Open House visitors please e-mail event_information@incrom.com or
call +81(6)6192-0002.

For other enquiries, please contact japan-info@incrom.com.

Jul 2007 InCROM Europe’s ICRU Grand Opening in London

Jun 2007 You're cordially invited to our ICRU Opening Ceremony in London

InCROM Europe's new 30-bed early phase clinical research facility, InCROM Clinical Research Unit (ICRU), will be holding an opening ceremony on July 5 from 14:00. Over 200 participants including top pharmaceutical companies and the Embassy of Japan are expected. Please contact Brendan Ellis, InCROM Europe's BD Manager, at brendan.ellis@incrom.com for details. We are looking forward to celebrating the special event with all of you!

May 2007 InCROM Europe's NEW clinical facility - ICRU

May 2007 DIA's 1st Conference in Japan for Asian New Drug Development

DIA's 1st Conference in Japan for Asian New Drug Development will be held in Aioi Sonpo Shinjuku Hall, Tokyo on May 17-18, 2007. InCROM Group will be one of the exhibiting companies, and a lunch-time presentation will be given by InCROM China's Director, Dr. Xun-Ting Zeng.

Apr 2007 InCROM China's Current Clinical Achievements

InCROM China's Completed/Ongoing Clinical Trials:

Apr 2007 Spring Bridging Issue - 'Are your eyes in good shape?'

To facilitate InCROM's subject recruitment, especially for ophthalmology studies, this spring issue focuses on eyes. Feature articles include information on glaucoma, cataract and LASIK (laser corrections for poor vision). To receive your copy, please contact our Public Information Department at bridging-jpn@incrom.com (Japanese) or our global support at angel.yim@incrom.com (English).

Dec 2006 Relocation - CRO Rabiton is more conveniently located!

Dec 2006 Presidential Announcement

Nov 2006 Expansion of InCROM China's Affiliated Network

Currently, there are about 200 SFDA approved hospitals in China for the conduct of clinical trials. InCROM China has recently collaborated with 10 more hospitals, few of which are ophthalmology specialists. The successful collaboration has expanded our affiliated network in China to 42 affiliates, which translates to 20% of the SFDA network.

Nov 2006 InCROM China's Upcoming Clinical Trial

Although InCROM China is InCROM Group's latest addition established in 2003, it has been showing remarkable growth. Since 2005, it's been growing at an exponential rate. Soon we will be starting our 1st ophthalmology study jointly managed by our latest affiliates.

Nov 2006 ToCROM Clinic newly renovated

ToCROM Clinic, InCROM's core affiliate, has just finished extensive renovations of their facilities. Along with the redesign of the layout of the clinic making it easier to use and providing greater patient comfort, meeting space has been created to hold information sessions for volunteers as well as to aid sponsor visits. In addition, InCROM has invested heavily in new state of the art equipment for the clinic, allowing the supply of the highest quality data to sponsors for Phase II-IV clinical studies.

Nov 2006 Fall 2006 Bridging Issue Featuring Hypertension!

The main objectives of our professionally published Bridging are to enhance Japanese subject recruitment, as well as to increase public awareness on health and clinical research. This fall issue is filled with a lot of interesting, easy-to-understand information pertinent to hypertension. Featuring articles include appetizing, low-sodium recipes created by our in-house dieticians. As a token of our appreciation, presents are given to readers (while supply lasts). To receive your copy, please contact our Public Information Department at bridging-jpn@incrom.com (Japanese) or our global support at angel.yim@incrom.com (English).

Aug 2006 Introducing InCROM Group at the 21st Scientific Meeting of the International Society of Hypertension

Aug 2006 New Asian Volunteer Panels by InCROM Europe

As London is one of the most cosmopolitan cities in the world, InCROM Europe is in an excellent location to recruit international volunteers for 1-site comparative studies. Due to sponsor demands, InCROM Europe has now invested in Korean and Chinese staff, enabling the creation of first generation Korean and Chinese healthy volunteer panels. InCROM Europe will now be able to conduct a greater range of comparative studies in the UK. One such study has already been planned.

Aug 2006 Introducing InCROM Europe is a CCRA member

Jul 2006 Heishinkai Medical Group, Inc.

InCROM Japan's newest core affiliated facility, OPHAC Hospital has just become a member of Heishinkai Medical Group, Inc. established in January 2006. OCROM Clinic, our other core affiliated facility, is also part of Heishinkai Medical Group, Inc..

Jul 2006 New Bridging Issue Published

Apr 2006 18th ANNUAL DIA EUROMEETING

Apr 2006 Updated HP

Apr 2006 Bridging Spring Issue!

Apr 2006 Moving Notice!

Feb 2006 The 18th Annual EuroMeeting

InCROM Europe is one of the exhibitors at this year's EuroMeeting. As an expert in conducting Japanese bridging studies outside Japan, we have prepared pertinent information for prospective clients and visitors. Our industry-experienced staff will be available to provide assistance on any clinical trial enquiries.

Feb 2006 Our Studies

InCROM China will soon be starting 2 large-scale PII studies in Allergic Rhinitis and Unstable Angina Pectoris. There will be 240 subjects in each study. In Japan, some of our ongoing studies include PII Perennial Allergic Rhinitis and PII Seasonal Allergic Rhinitis, which InCROM Japan has been well recognized for due to our outstanding achievements over the years. Other ongoing studies include Type II Diabetes, Hypertension, Dry Eye and Bronchial Asthma.

Feb 2006 Staff Recruitment

At present, there is a total of 250 staff working for InCROM Group. One of our corporate expansion projects is to double the number in 5 years. Our focus will be on recruiting industry-experienced professionals who clearly show a sense of globalization and have experience in a multicultural work environment.

Feb 2006 Continual Professional Development

In order to maintain the quality of our services to clients, InCROM Group sets high standards for our staff. At the same time, we value support for our staff so that they can meet our high standards. Support is provided for them through continual professional development managed by our Employee Education Department. The upcoming educational session will be on professional manner and it will be held in Japan.

Feb 2006 New IRBs in Tokyo and Osaka

ToCROM Clinic (Tokyo) and OCROM Clinic (Osaka), InCROM Japan's core affiliated clinics, are being expanded. New IRBs have been established. For the ToCROM IRB, meetings will be held once every 4 weeks (on Monday) and the first meeting will be held on February 20. For the OCROM IRB, meetings will be held once every 4 weeks (on Wednesday) and the first meeting will be held on February 15.

Dec 2005 Kick-off of OPHAC Hospital in Osaka, Japan

Dec 2005 InCROM Group’s New Look

Dec 2005 The 26th Annual Meeting of Japanese Society of Clinical Pharmacology and therapeutics (JSCPT): December 1-3, 2005 in Beppu City, Oita Prefecture, Japan

Dec 2005 Collaboration with Cambridge Regulatory Services

In order to provide comprehensive services and further cater to client needs, InCROM Europe has affiliated with Cambridge Regulatory Services, a leading consulting company with expertise in advising on regulatory affairs such as clinical trial applications (CTA). The founder of Cambridge Regulatory Services previously worked at the Medicines and Healthcare Products Regulatory Agency (MHRA) for an extensive period of time, making him very knowledgeable where regulatory affairs in the EU are concerned.