Dr. Joanne Jiang, representing Fountain Medical Development, invited to present at BIO in San Diego.http://www.fountain-med.com/news.php?id=11www.fountain-med.comInternational Competitiveness Track: Doing Business Globally, Breakout Sessions
Date: Wednesday Jun 18, 2008  Time: 2:00 PM - 3:30 PM
Speaker: Leslie Platt, Esq - Chair | Company: Pillsbury Winthrop Shaw Pittman,LLP 
Joanne Jiang, PhD, MBA, Fountain Medical Development and others
This Panel will explore the key financial and policy features, benchmarks and differentiators of global competitiveness in biopharmaceuticals research and development, and commercialization. The Panel will examine differential product development costs in the U.S., Canada, Europe, Asia, and Latin America.  It will explore what various stakeholders should do now to prepare for globalization, and will discuss foreign outsourcing and how U.S. and other biopharmaceuticals organizations and markets are approaching these issues.

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Fountain Medical Development display at ASCO,Chicago at booth number 21131. Please visit our booth!http://www.fountain-med.com/news.php?id=12www.fountain-med.comFountain Medical Development will be displaying at ASCO 2008, Chicago at booth number 21131.  Please visit our booth!

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Clinical Development in China: Current Status and Future Trendshttp://www.fountain-med.com/news.php?id=14www.fountain-med.comSoaring drug development costs ¨C coupled with slim prospects for obtaining blockbuster
products ¨C have driven pharmaceutical companies to look for cost-reduction strategies in
nearly every area of their business. One of the leading initiatives for cost reduction is the
mobilization of more clinical trials to Asia and Latin America.
In the current environment, China has become an increasingly attractive place to host
global standard clinical studies. Not only does China provide the vast number of patients
suitable for a variety of therapeutic areas pursued by global pharmaceutical companies
and medium- and small-scale biotechnology firms, but it also provides the fastest
growing pharmaceutical market worldwide. This scenario allows ample commercial
return as a result of successful registration using Chinese clinical study results.
Benefits of Conducting Research in China
Opening Chinese study sites likely is the best insurance policy for the timely completion
of ongoing or planned clinical studies for almost all drug development programs. tIndeed,
timeline delays have been a major issue for many drug development programs. Statistics
have demonstrated that more than 70 percent of trials drag beyond the expected
completion deadline. ¡°Last patient enrolled¡± becomes an ever-demanding milestone for
many clinical study teams to reach.
Incorporating China into a company¡¯s global development program often allows the
project team to boost patient enrollment mid-way into the study, enabling the enrollment
curve to ramp up quickly and achieve recruitment goals in advance of the expected
timeline. This time savings frees up additional resources for both the clinical team and
the development team. In addition, an advanced development timeline usually leads to
faster registration, which translates into a highly significant commercial advantage. For
example, a blockbuster product entering the market one day earlier than planned can
result in hundreds of thousands of dollars in additional sales worldwide.
Acceptance of Chinese clinical study data has been demonstrated by both verbal
communications and actions taken by the Food and Drug Administration (FDA), the
European Medicines Agency (EMEA) and Japanese regulatory agencies. There have
been seven audits performed in trial sites in seven different cities throughout China by the
FDA since 1999 which yielded no major citations. The FDA also has granted label
changes based on a large outcome study solely performed in China.
The EMEA repeatedly has accepted Phase II and Phase III studies with Chinese patients
as a significant component of the studies. Moreover, the Japan regulatory agency, Kikko,
recently has acknowledged a willingness to accept data generated from clinical studies in
China.
Finding Right Chinese Partner Is Key
Naturally, driven by increasing market demand and supported by a positive regulatory
landscape, moving clinical studies to China already is occurring. To date, most of the
Western-standard clinical studies are conducted by contract research organizations
(CROs) and Chinese subsidiaries of global biotech or pharmaceutical companies. One
important aspect of making these studies successful is identifying the right partner(s) in
China. For a typical clinical trial, sponsors usually work through a Chinese CRO or an
internal clinical operational group in China.
In either case, it is important for a pharmaceutical or biotechnology company to establish
a well-thought out communication plan. This plan not only must support communication
within the operational team, but also has to adequately manage communications with
investigators and the clinical research associates (CRAs). For companies that do not have
a division in China, choosing the right CRO to implement projects is the most important
decision.
In terms of evaluating different CROs in China, sponsors often are impressed by low
price quotations and sometimes overly positive promises, which can be both misleading
and inaccurate. To avoid common CRO selection pitfalls, sponsors should interview key
personnel on the project team, e.g., the project manager, and the lead CRA, data manager,
etc.
Questions focusing on the trials details usually can identify potential weaknesses early in
the interview process. In addition, the communication and working style of these key
team members are very important. CRO staff should be able to communicate effectively,
using English, in oral and written forms. They should also value and practice basic
teamwork tenets, i.e., honesty, openness, the ability to work independently and
responsibility for their deliverables.
One unique aspect of conducting clinical studies in China is that CRAs spend more hours
at the investigator sites as compared to time spent for studies performed in the United
States or the European Union. Because the clinical research experience levels are
different among the Chinese investigators, it is critical that CRAs set appropriate levels of
monitoring for each site. Prior to study initiation, CRAs need to properly gauge the level
of experience at each particular site and work with the investigator and site coordinator to
address all details required by protocol during initiation and subsequent study visits.
The additional hours spent per study site rarely results in higher cost of clinical studies,
because the number of sites required in China is much lower than those that would have
been needed for the United States. This decrease in sites in China is attributed to the
number of patients enrolled per site ¨C typically 10 to 20 times higher than those in the
United States. China has a highly concentrated hospital system in metropolitan areas and
Chinese hospitals are usually large, with up to 1,500 to 3,000 beds per hospital. Due to a
lower number of sites and a high patient enrollment rate, it is highly feasible for each
CRA to focus on two-to-three key sites in the same city for a particular study. This allows
more consistency in monitoring and controlling study implementation processes.
Clinical Trial Offerings in China To Increase
As China hosts more and more global standard clinical studies, it is not hard to imagine
that the scope of supporting services also will expand. For example, global central
laboratories have begun to put their footprints in China by opening subsidiaries in cities
like Beijing and Shanghai. Related pharmacogenomic as well as biomarker analytical
capabilities also are being established in China. Leading CROs in China already have
expanded into this area and are expediting blood sample analysis by conducting assays
locally during and after clinical studies.
In the near future, the central lab business will grow tremendously as a result of both an
increasing number of trials and a lack of alternatives. It is a well known fact that the
Chinese government purposely restricts shipping blood samples outside of China due to
concerns over leaked genetic information. This makes it necessary to analyze blood
samples for Chinese subject locally.
Challenges To Consider
In the midst of a booming clinical studies surge in China, there are a few challenges that
need to be overcome to improve the overall environment for clinical study there. One of
the biggest challenges is the investigational new drug (IND) review timeline. Currently, it
takes at least eight to 10 months to open an IND in China. China¡¯s State Food and Drug
Administration (SFDA) is rolling out a ¡°green channel¡± concept, which could accelerate
the review timeline to six-to-eight months. Review priorities will be given to compounds
or biologicals that are novel, first-in-class and address significant, unmet medical needs
in China through their commercialization.
In light of the long regulatory approval time, to fully benefit from the excellent patient
enrollment results in China it is critically important to have a well-planned global
development program that includes China early in the process. If China is only an
afterthought or a last resort due to a delayed trial, the long IND review timeline is likely
to undermine the clear benefit of high Chinese trial enrollment rates to the global
development program.
Many study sites in Beijing and Shanghai host at least four ongoing clinical studies. The
majority of the Chinese divisions of global pharma companies also are located in these
two cities. As a result of this concentration, hospitals in these areas were the first to be
accessed by the Chinese divisions of the top 10 players in the industry.
Although experienced investigators may be occupied with several therapeutic areas
(especially in oncology, cardiovascular and diabetes, etc.) in the top hospitals in first-tier
cities, companies must recognize that there are numerous SFDA-certified hospitals in the
second-tier cities that are willing to cooperate with sponsors to conduct early- or latephase
clinical trials. These investigators have already passed good clinical practice
training and have been audited by the SFDA; they are very cooperative, eager to learn
and willing to follow procedures. With the proper training and monitoring, these sites can
and will deliver the same quality of clinical trial conduct as the top sites in Beijing or
Shanghai provide.
In summary, China has proven to be capable of delivering high-quality clinical studies
with moderate cost, and increasingly supportive and associated services for clinical
development also are being established in China. As such, these factors are driving most
of the top 20 pharmaceutical and biotech companies worldwide to incorporate China into
their routine drug development programs.
However, there are new challenges to face as more clinical studies make their way into
China. Improving IND review timelines and clinical study expertise at more clinical trial
sites, especially those in secondary cities, are two of the most important priorities to
ensure China¡¯s continued success and allow it to be the preferred country for clinical
research.
Dr. Joanne Jiang, Ph.D., MBA, is the co-founder of Fountain Medical Development, a
contract research organization (CRO) offering a full range of ICH GCP-compliant
clinical research services in China for multinational clients. In the pharmaceutical
industry for 12 years, Dr. Jiang started her career in preclinical pharmacology area at
Bayer pharmaceutical and Eli Lilly, working as research scientist, lab head and project
leader, and furthered her expertise in drug development and project management as a
global project manager. She has worked for Aventis and Daiichi Sankyo, managing drug
development and life cycle management projects, encompassing preclinical to Phase IV
activities, with a particular focus on clinical trial planning and management, and the
integration of marketing plans and regulatory strategy to enable optimal trial design.
joanne.jiang@fountain-med.com
 

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.http://www.fountain-med.com/news.php?id=10www.fountain-med.comARMENIA GATEWAY TO MAJOR MARKETS

 

 

FMD K&L Armenia ribbon ceremony

 

 

FMD K&L Armenia delivery International Biotechnology Park Official opening

 

 

FMD K&L Armenia Biotech Park

 

 

FMD K&L Armenia Biotechnology Park Official Opening by Armenia TV News

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Come see us at IBC pharmaceutical R&D summit, Shanghai, China, April 7-9, 2009.http://www.fountain-med.com/news.php?id=15www.fountain-med.comFountain will be displaying at China 2009 R&D summit.  http://www.IBCLifeSciences.com/china
Dr. Dan Zhang will be leading the session on clinical development and outsourcing.
 

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Fountain Medical and ProteLight Receive ChinaBio®s "Most Promising" Awardhttp://www.fountain-med.com/news.php?id=16www.fountain-med.comAt the 4th ChinaBio® Investor Forum, held in Beijing on December 11 and 12, 2008, two companies received the prestigious "Most Promising Company" award.  Selected by a panel of venture capitalists actively investing in the China biotech industry, Fountain Medical Development Ltd. won the award in the services category, and ProteLight Pharmaceutical & Biotechnology Co., Ltd won the drug development category

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Dr. Dan Zhang was interviewed by PharmaAsia news on the new drug safety regulation issued by SFDA.http://www.fountain-med.com/news.php?id=17www.fountain-med.com"The new version has expanded significantly ¡¬ It clearly spells out the reporting timeline for death case, as well as AE and SAEs. It also clearly identifies the role/responsibilities of city level, provincial level and SFDA in handling AE and SAE cases. "For detail information on the new regulation and its impact on conducting clinical trials in China. Please contact FMD for one-on-one consultation.

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Fountain will exhibit at both ASCO and DIA Annual Meetings next month.http://www.fountain-med.com/news.php?id=18www.fountain-med.comCome see us at ASCO, Chicago, USA, June 5 to 7, 2010, Booth # 2011
 
Come see us at DIA, Washington DC, USA, June 14 to 16, 2010,Booth # 1905
 
Fountain will exhibit at both ASCO and DIA Annual Meetings next month. Principals from our China offices are excited to be there to answer any questions you have about what has become the new frontier in drug development.
 
China's pharmaceutical market is growing at 22 to 24% annually.   China offers large number of patients as well as treatment naïve patients.   Talking to the leading full service CRO, Fountain, will give you the assessment of how to best utilize China in your global development program and maximize the value of your portfolio.
 
Look forward to seeing you at these events.
 

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Fountain will exhibit at the 2011 ASCO Annual Meetinghttp://www.fountain-med.com/news.php?id=19www.fountain-med.comCome see us at ASCO, Booth #3087, in Chicago, USA, June 4 to 8, 2011! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2012 DIA China Annual Meetinghttp://www.fountain-med.com/news.php?id=20www.fountain-med.comCome see us at DIA China 4th Annual Meeting, Booth #C10, in Shanghai International Convention Center, Shanghai, China, May 20 to 23, 2012! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2012 ASCO Meetinghttp://www.fountain-med.com/news.php?id=21www.fountain-med.comCome see us at ASCO Meeting, in Chicago, USA, June 2 to 5, 2012! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 24th Annual DIA Euro Meetinghttp://www.fountain-med.com/news.php?id=22www.fountain-med.comCome see us at DIA Euro Meeting, Booth #410, in Copenhagen, Denmark, March 26 to 28, 2012! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain Medical Development: Clinical trials, government involvement and China's futurehttp://www.fountain-med.com/news.php?id=23www.fountain-med.comDr. Joanne Jiang, interviewed by Pharma Television,‘Fountain Medical Development serving clients’ clinical development needs in Asia.

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Dr. Dan Zhang will make a speech at China Forum 2012http://www.fountain-med.com/news.php?id=24www.fountain-med.comNovember 11, 2012, our CEO Dr. Dan Zhang will make a speech about “Navigating China’s regulatory environment” at the China Forum 2012.

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News Releasehttp://www.fountain-med.com/news.php?id=25www.fountain-med.comAs one of the fastest growing clinical CRO in Asia and China, Fountain Medical Development (FMD) established eight operation offices throughout China, Hong Kong, Taiwan and Korea, including strong operation of Data Management and Biostatistics, with experienced Biometrics team in both US and Nanjing.
FMD’s core competency resides in managing multi-country pivotal clinical studies for filing at FDA, EMEA and CFDA. 
In synergy with the soaring growth of Phase I-IV clinical trial needs in China and Asia, FMD has grown its operation team to more than 200 staff, providing full solutions to support local registration as well as medical affairs, licensing in program needs for clients in US, EU and Asia.   In order to address the needs of early phase studies in multiple therapeutic areas, FMD expanded its phase I operation from single site into a network approach.   
In 2013, FMD’s main focus will continue to be providing superior quality services as the strong local partner for global and domestic pharmas and biotechs.
 

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Fountain will exhibit at the 2013 DIA China Annual Meetinghttp://www.fountain-med.com/news.php?id=26www.fountain-med.comCome see us at DIA China 5th Annual Meeting, Booth #B4, in Beijing International Convention Center, Beijing, China, May 12 to 15, 2013! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2013 China Medical Affairs Summithttp://www.fountain-med.com/news.php?id=27www.fountain-med.comCome see us at 2013 China Medical Affairs Summit, Booth #1, in Shanghai International Convention Center, Shanghai, China, June 18 to 19, 2013! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier! 

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Fountain will exhibit at the China Trials 2013http://www.fountain-med.com/news.php?id=28www.fountain-med.comCome see us at China Trials2013, Booth #22, in Beijing International Convention Center, Beijing, China, Nov 13 to 15, 2013! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Dr. Dan Zhang will make a speech at the 2014 SABPA Science &Technology Forumhttp://www.fountain-med.com/news.php?id=29www.fountain-med.comCome see us at 2014 SABPA Science &Technology Forum, in San Diego, USA, March 29, 2014! Our CEO Dan Zhang will make a speech about at the Forum. Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2014 DIA China Annual Meetinghttp://www.fountain-med.com/news.php?id=30www.fountain-med.comCome see us at DIA China 6th Annual Meeting, Booth #B14, in Shanghai International Convention Center, Shanghai, China, May 11 to 14, 2014! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will attend the 50th Annual DIA Euro Meetinghttp://www.fountain-med.com/news.php?id=31www.fountain-med.comCome see us at DIA 2014 50th Annual Meeting, in San Diego, California, June 15 to 19, 2014! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will attend the 2014 BIO International Conventionhttp://www.fountain-med.com/news.php?id=32www.fountain-med.comCome see us at 2014 BIO International Convention, in San Diego, California, June 23 to 26, 2014! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2014 ASCO Meetinghttp://www.fountain-med.com/news.php?id=33www.fountain-med.comCome see us at ASCO Meeting, Booth # 13089, in Chicago, USA, May 30 to June 3, 2014! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2015 DIA China Annual Meetinghttp://www.fountain-med.com/news.php?id=34www.fountain-med.comCome see us at DIA China 6th Annual Meeting, Booth #B35, in Shanghai International Convention Center, Shanghai, China, May 24 to 27, 2015! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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Fountain will exhibit at the 2015 ASCO Meetinghttp://www.fountain-med.com/news.php?id=35www.fountain-med.comCome see us at ASCO Meeting in Chicago, USA, May 29 to June 2, 2015! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

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FMD K&L Inc. Expands Operations to Armenia to Support Business Growthhttp://www.fountain-med.com/news.php?id=36www.fountain-med.comYerevan, Armenia; 1 July, 2015 – FMD K&L Inc., a privately owned contract research organization (CRO) with headquarters in the US and China, recently expanded their operations to Armenia to support their customers’ needs in the region and the growth of their business in Europe.  

 

This office will support client needs for a range of services including study management, data management, biostatistics, programming, clinical data interchange standards consortium (CDISC) compliant eSubmission, medical writing such as protocol development and report writing, monitoring of European clinical sites, and safety handling.

 

“FMD K&L Inc. has already established their footprint in both the US and China up until this time; however, with our expansive growth potential and ongoing commitment to make ourselves easily accessible to our clients, we felt as though our investment to grow the business in this region was vital and look forward to continued growth in the future,” says Dan Zhang, CEO.

 

We will be holding a ribbon cutting ceremony at our new offices in Yerevan, Armenia on Friday, 10 July 2015 at 6:30pm.  Members of the local government and media are invited to attend.  Please plan to arrive between 6:00 – 6:15pm and show press credentials upon arrival.  Following the ribbon cutting, members of the executive team will be available to answer questions and take you on a tour of our new facility.  Photos and video will be permitted.   

 

“Our initial move into the area has been extremely successful and we have already surpassed our capacity at the current location.  We are looking to expand to a larger space in the coming months, growing our staff from 18 to 30 in 2015 and to 60 by the end of 2016,” says Kirit Velani, Client Development Director.
 
About FMD K&L Inc.

FMD K&L Inc. is a Contract Research Organization (CRO) offering data management, biostatistics, statistical programming, CDISC compliant eSubmission, site monitoring, and medical writing services to the pharmaceutical, biotechnology, and medical device industries worldwide.  In addition, we provide regulatory affairs in China and South East Asia, and clinical operations in mainland China, Hong Kong, Taiwan, and South Korea.  Our services encompass end-to-end solutions utilizing industry data standards and rigorous operating procedures that enhance our clients’ ability to get their products approved faster, at minimum risk, and lower cost in order to meet patients’ needs for advanced medicines.
 
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Contact:

Catherine Ditzler
Marketing Manager

1.215.283.6035

catherine.ditzler@klserv.com

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FMD K&L opening in Armenia, 2015http://www.fountain-med.com/news.php?id=40www.fountain-med.com 

 

 

It gives me great pleasure to announce the success of our FMD K&L opening in Armenia, 2015. After months of team’s hard work, we have entered into the gateway of Europe. The evening commenced at 7pm on a hot, continental evening in Yerevan, the capital. The honorary guests and VIP’s were invited to witness the introduction and global strategy for FMD in Armenia and Europe. Dr. Henry Wu made a special trip to the event for the inaugural ribbon cutting ceremony. This was followed by a succinct introduction for the honorary guests and VIP’s about his place in FMD and his impression of the unity within the Armenian branch. Dr. Wu commented on the cultural characteristics imbuing within Armenia along with its deep and expansive history, concluding that the importance of education services (especially relating to the medical field) and location of Armenia makes it the perfect gateway for a pharmaceutical market in Europe.

 

Among the invited guests was John D. Balian, MD, an experienced Senior Executive in Multinational companies including Pfizer Inc and Johnson & Johnson. He was in Armenia on a family vacation and did not want to miss this very auspicious occasion. In his introduction, Dr Balian, highlighted the importance of FMD’s work as the ‘second largest CRO in China’, emphasizing that there ‘is nothing small in China’! Dr. Balian’s natural charisma and experience in the field shone through as he bilingually engaged with the audience in Armenian and English. Dr. Balian overtly expressed the healthy working relationship between FMD and this organization, welcoming future plans and the development strategy of FMD.

 

Drinks and canapés were on hand to make a fitting taste, talk and tour of the offices. Relevant and useful leads were generated throughout the evening as people from local companies came to be entertained and inspired by the work FMD is doing in a rich and untapped country. During the evening, a presentation was given on the topic of ‘Importance of Clinical Trials’ with an added focus on patient perspective. Dr Karapet Davtyan, Study Manager, summed up the evening and closed with a final speech thanking all the honorary guests and VIP’s attending the event.

 

FMD’s investment and branching off into Armenia has turned out to be a success from all involved. FMD’s expansion in Armenia will continue to increase, as will the productivity, ability and unity of the FMD ‘Pharmily’.

 


Sincerely,

Kirit Velani

Director of International Client Engagement

 

 

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Armenia Office on Local TV Newshttp://www.fountain-med.com/news.php?id=42www.fountain-med.comFMD K&L Armenia ribbon ceremony

http://v.youku.com/v_show/id_XMTI4OTA3NTIyNA==.html?from=s1.8-1-1.2

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FMD K&L Inc. Expands Operations to Japan to Support Client Needs at a Local Levelhttp://www.fountain-med.com/news.php?id=43www.fountain-med.comTokyo, Japan; 29 October, 2015 – FMD K&L Inc., a privately owned Contract Research Organization (CRO) with headquarters in the US and China, recently expanded their operations to Japan to support client needs at a local level.

As we continue to grow our footprint throughout the globe, we put the needs of our clients first. “We have anticipated that our clients would need CDISC conversion services in Japan given the new regulatory changes that are quickly approaching in the near future,” said Dr. Dan Zhang, CEO. “With our expertise on CDISC compliance and our extensive experience on supporting our clients for regulatory submissions we are able to provide high quality services to suit their needs.”

This office will support client needs for a range of services including data management, biostatistics, statistical programming, clinical data interchange standards consortium (CDISC) compliant eSubmission, regulatory services, and clinical operations.  We will also assist Japanese clients who would like to enter the China market by offering clinical project services including regulatory affairs, project management, clinical site monitoring, and site management.

Although we have just established our footprint in Japan, we have extensive experience working on projects in this region.  This in turn makes us a trusted partner that will utilize our expertise to provide cost‐effective and high quality work for your next project.

About FMD K&L Inc.

FMD K&L Inc. is a Contract Research Organization (CRO) offering data management, biostatistics, statistical programming, CDISC compliant eSubmission, drug safety, and medical writing services to the pharmaceutical, biotechnology, and medical device industries worldwide.  In addition, we provide regulatory affairs in China and South East Asia, and clinical operations in mainland China, Hong Kong, Taiwan, South Korea, and Europe. We continuously strive to raise the standard of excellence through accuracy and efficiency. This results in high quality output to get our client’s drug or medical product approved faster and to improve the lives of patients.

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Contact:

US Contact                                                                       Japan Contact

Catherine Ditzler                                                             Sanae Fujita (藤⽥ 早苗)

Marketing Manager                                                         Director of Business Development

1‐215‐283‐6035                                                              81‐3‐6228‐7360

catherine.ditzler@klserv.com                                        sanae.fujita@fountain‐med.com

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Fountain will exhibit at the 2016 DIA China Annual Meetinghttp://www.fountain-med.com/news.php?id=44www.fountain-med.comCome see us at DIA China 8th Annual Meeting, Booth #C3, in Beijing International Convention Center, Beijing, China, May 15 to 18, 2016! Principals from our China offices will be there to answer any of your questions about clinical development and drug markets in the China /Asia region – truly the New Pharmaceutical Frontier!

 

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China-Based CRO Selects Oracle Cloud to Optimize Clinical Trial Data Managementhttp://www.fountain-med.com/news.php?id=49www.fountain-med.comFountain Medical Development (FMD), a full-service Contract Research Organization (CRO) headquartered in Beijing, China, and its US affiliate, FMD K&L, have adopted Oracle’s cloud-based clinical data management solutions, to increase operational efficiencies and speed time to market. The solutions deliver increased productivity to the company’s drug development process, reduce overall costs, improve communications with its sponsors, and advance clinical study quality and speed, worldwide.

FMD was able to retire its aging, antiquated, legacy system and migrate to a more cost-effective cloud-based environment with Oracle Health Sciences InForm and Oracle Siebel Clinical Trial Management System (CTMS). The new, unified, technology platform has enhanced capabilities in data management, study planning and design, trial operations, analytics, and patient engagement.

“We are committed to delivering innovative solutions to our sponsors. This is why FMD decided to work with Oracle,” said Dr. Henry Wu, CEO, Fountain Medical Development. “Oracle’s data management solutions will enable us to improve our data quality, advance our trial data management efficiencies, reduce costs, and gain a deeper understanding of our clinical trial data across FMD’s integrated enterprise globally.”

Fountain Medical Development is a leading CRO offering a full range of International Conference on Harmonization Good Clinical Practice (ICH GCP) compliant clinical research services for multinational clients conducting clinical research in China. As one of the fastest growing clinical CROs in East Asia and China, FMD has established 12 operational offices throughout China, Hong Kong, Taiwan, Japan, Korea, the United States, and Armenia, with a strong focus on data management and biostatistics.

By moving to Oracle Health Sciences InForm and Oracle Siebel CTMS), FMD will gain powerful analytics capabilities that will provide a faster and better understanding of its clinical trial data across its locations, saving the company time and effort.

“Clinical research is becoming more complex and holistic by the day, and contract researchers are challenged to provide more services than ever before. Oracle Health Sciences provides global contract research organizations, like FMD, with an integrated platform and advanced analytics tools to help CROs and their sponsors find the cures of tomorrow,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences.

FMD is a member of the Oracle CRO Advantage Program, an initiative that helps drive CRO success with Oracle Health Sciences products through training, sales and marketing support, and bi-directional communication on Oracle products and strategy.

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Eventshttp://www.fountain-med.com/news.php?id=48www.fountain-med.comWe’ll be attending the following upcoming industry conferences.  We hope to see you there!

 

Conference:2018 SAPA Annual Conference

Date:October 5, 2018

Location:Somerset, New Jersey

Speaker:Haishan Xiong

Speech Topic: Accelerate Development and Maximize Values of Innovative Drugs -Leverage CFDA’s Adoption of ICH Standards

 

Conference:2018 CBA Annual Conference

Date:October 6, 2018

Location:Foster City, California

Speaker:Dan Zhang

Speech Topic:  Accelerate New Drug Development - Paradigm Shift in The Post-ICH Regulatory Systems in China, and US

 

Conference:CABS Regulatory Forum

Date:October 7, 2018

Location:San Francisco, California

Speaker:Dan Zhang

Speech Topic: Comparison of Regulatory System Between US and China

 

Contact us today to schedule a meeting with us onsite!

 

Contact FMD: Aprille Walker, Aprille.Walker@fountain-med.com

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FMD K&L Europe unit Yerevan Hosts Seminars on Clinical Researchhttp://www.fountain-med.com/news.php?id=50www.fountain-med.comFMD K&L Europe unit in Yerevan, Armenia conducts workshops on the topic of “Experience and Potential of GCP clinical trials in Armenia” since May, 2016.
This is the first step towards a new bright future of Armenia Bio-industry, which also attracts the attention of Armenian local media-news.am. The following is the article written in the website of news.am.


http://med.news.am/arm/news/11072/erevanum-klinikakan-hetazotutyunneri-veraberyal-seminar-e-yntanum.html

Yerevan Hosts Seminars on Clinical Research
12 July, 19:40

Yerevan hosts seminars on “Experience and Potential of GCP clinical trials in Armenia”, organized by FMD KL Europe Contract Research Organization in cooperation with Armenian Association of Young Doctors.
FMD KL Europe Business Development Specialist Alla Aristakesyan mentioned to NEWS.am Medicine reporter that the aim of the seminars is to share knowledge of conducting GCP (Good Clinical Practice) clinical trials in compliance with standards that are globally adopted, as well as to share the experience and potential of conducting such clinical trials in Armenia. Alla Aristakesyan briefed that the Seminar-Workshop is organized in the scope of the “Armenian Biotech Development Forum” long-term state project and the international forum that is going to take place in the near future.
It is worth mentioning that the program of the seminars has been approved by the RA Ministry of Health and the participants will receive 2 CME credits and nominal certificates.
Note that GCP standard is international standard on ethical norms and quality of scientific researches, which covers rules on research initiation, conduction, documentation and the preparation of reports of studies that involve human participants.
These rules have been formulated in ICH (International Conference on Harmonization) and the Declaration of Helsinki.
Like GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice), GCP is meant to standardize some aspects of the medical service of the population. GCP, GMP and GLP are considered to be “three whales” of evidence-based medicine.

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FMD K&L Merged with iMEDGlobalhttp://www.fountain-med.com/news.php?id=51www.fountain-med.comFort Washington, PA; 13 October, 2016 – FMD K&L Inc. (FMD K&L) and iMEDGlobal Corporation (iMEDGlobal) are pleased to announce that they have entered into a merger agreement. FMD K&L is a privately owned Contract Research Organization (CRO) with headquarters in the USA and China. iMEDGlobal is a privately owned CRO with headquarters in the USA and with main delivery centers in India and the Philippines.

The services, clientele, and delivery centers of the companies are complementary in nature, providing  alignment towards the same strategic direction. The merger enables the combined entity to realize cost and revenue synergies across operational integration, a broader spectrum of services, an extended customer base, an expanded global presence, and a stronger sales force. It will also be better equipped to create sustainable value for the clients and institute better business focus for the company and the workforce.

By leveraging the joint capabilities across both firms, including FMD K&L’s extensive experience in CRO services which include Clinical Operations, Data Management, Biostatistics, Statistical Programming, and eSubmissions/CDISC as well as iMEDGlobal’s service inventory across Pharmacovigilance, Regulatory, Toxicology, and Medical Affairs, it enriches the existing service portfolio of the individual firms and will in turn create benefits to our clients, geographies, and markets.

The merger results in a wider geographical coverage with 19 offices across the globe in countries like the USA, UK, Philippines, India, China, South Korea, Japan, Taiwan, and Armenia. The combined entity will have over 1200 employees. It will be able to provide flexibility in delivery and engagement models, coverage in all time zones, and faster access to the local service team.  Backed with an in-house multi-lingual workforce, the company will be in a position to extend regional support for global projects, especially in markets which have language dependencies.

“The combined entity will be led by a strong leadership team possessing substantial prowess in the Pharma and CRO industry,” says Dr. Xin Ke, CEO, FMD K&L. “Driven by our core values of accountability, innovation, leadership, quality, and partnership, the company will be prepared to expand its operations across the globe. The combined team of leaders share the same vision, culture, and values which will help in the smooth transition and will also be pivotal in propelling the company for monumental performance.”

“The merger itself resulted in achieving synergies in terms of better geographical coverage, a stronger talent force, and a more comprehensive service menu for our clients in the life sciences industry,” states Dr. Dan Zhang, Executive Chairman, FMD. “Further, the company will be better positioned to take up large-scale projects in new and existing markets.”

Mr. Prashanth Visweswaran, Founder and Executive Chairman, iMEDGlobal states, “The merger represents a culmination of business interests to propel the company to the next level. The strategic advantage of complementary businesses will be instrumental in unlocking greater value for worldwide clients, stakeholders, and the employees. As near-term benefits from this merger, we foresee upward trajectories in revenues, global expertise in service delivery, and growth opportunities for our employees.”

About FMD K&L

FMD K&L is a Contract Research Organization (CRO) offering data management, biostatistics, statistical programming, CDISC compliant eSubmission, medical writing, and clinical operations to the pharmaceutical, biotechnology, and medical device industries worldwide.  In addition, we provide regulatory affairs services in China and South East Asia.  We continuously strive to raise the Standard of excellence through accuracy and efficiency.  This results in high quality output to get our client’s drug or medical product approved faster and to improve the lives of patients.

About iMEDGlobal

iMEDGlobal is a global CRO specialized in regulatory affairs, product safety and toxicology, medical affairs and technology, and clinical operations for biopharmaceutical, medical device, and consumer healthcare industries. Headquartered in Princeton, New Jersey, USA, iMEDGlobal has a presence in the USA, UK, India, and Philippines with delivery centers across these areas ensuring fast execution of the services. 

Contact:

 

Catherine Ditzler                                                                                                                                

Senior Marketing Manager                                                                                                              

FMD K&L                                                                                                                                            

1-215-283-6035                                                                                                                                  

catherine.ditzler@klserv.com                                                                                                           

 

Gargi Kumari                                                                                                                                

Global Marketing Head                                                                                                             

iMEDGlobal                                                                                                                                         

1-609-759-6900                                                                                                                                 

gargi.kumari@imedglobal.com

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Dr.Dan Zhang and Dr.Xiong addressed at high-end pharmaceutical conferences to analyze ICH impacthttp://www.fountain-med.com/news.php?id=55www.fountain-med.comThe impact of China's new ICH membership is front and center in the minds of Pharma executives. Case in point, FMD attended two high level conferences this past week and presented to our insights into this topic. 

 

The 2017 International Conference on Pharmaceutical Innovation and Development was held in the beautiful coastal city of Yantai on 17-18 September.   Dr. Dan Zhang, chairman of FMD, expert of “Thousand Talents Plan”, delivered a keynote speech entitled "opportunities and challenges brought by ICH".

 

Dr. Zhang pointed out that the CFDA has been carefully preparing for the ICH for some time. In the past 3 years, the agency released a multitude of policies in line with ICH standards, such as No. 52, 53, 54, 55 Guidance Documents (Draft), replacing certification of clinical trial institutions by record-keeping system, optimization of inspection procedures, accepting of foreign clinical trial data, and so on. Through the implementation of Marketing Authorization Holder (MAH) system and many other policies, we can see that the CFDA has long been paving the way for joining the ICH.     

    

Of course China still has a long way to go to bring itself fully in line with ICH, including the number of technical guidelines, the experience of clinical researchers, the number of clinical research institutions. Challenges represent opportunities. For pharmaceutical companies, what will they do after ICH implementation? What kind of products will they develop to take advantage of the new environment? And how to find experienced clinical research institutions and operation team? For the investors, joining the ICH presents a real challenge of taking a fresh look at the overall strategy. Pharmaceutical companies and investors are both facing the corresponding challenges. All of these challenges require investors and pharmaceutical executives to re-think their businesses.  

 

For China, joining ICH will do more good than harm to the domestic pharmaceutical industry. New drugs or orphan drugs can now more easily enter the international market, accessing much larger markets to recoup investments. As a result of a unified R & D market, global investment, especially in China, will be more valuable. More widely clinical data sharing make it possible to reduce repeated clinical trials. Investment is, in some ways, more efficient at a reasonable valuation. China's accession to the ICH will improve the overall research capabilities of new drugs. Who will be the winner? First of all, the biggest winners are patients. Chinese patients can access new and better drugs earlier than before. Doctors can offer patients more choices. Moreover China can participate in early phase clinical trials, allowing doctors to experience innovative drugs earlier, making it easier for researchers to innovate. Third winners are CROs, not only the clinical CROs but also the SMO, CMO and others in the value chain. Fourth is innovative pharmaceutical enterprises.

 

Meanwhile in western China, hundreds of scientists and executives gathered at the 4th World Nobel Laureates Medical Summit on September 16th, 2017 in Guiyang, an area known for its traditional medicine prowess. Five Nobel prize winners, more than ten Chinese and American academicians, over 100 distinguished experts, together with prominent leaders and senior investment institutions from biopharmaceutical industry in and outside of China participated in the summit, circling round the theme “Science-Fact and Fiction” to discuss the major program of medical science and technology.

 

FMD's Vice President Dr. Haishan Xiong gave a featured speech on ICH impact. Dr. Xiong focused on the strategic and the practical aspects of the trends in the market. He concluded that the drug industry is becoming a single global market. Those enterprises who invest in innovation and are prepared to take on the execution risks will thrive in this market. 

 

Later Dr. Xiong participated in a panel discussion on cross boarder investment, which FMD has done a couple of times in its 10-year history. One of the panelists is Nobel Laureate Dr. Steven Chu, former Secretary of the Department of Energy of the USA. The panel was vibrant and attracted many participants. 

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FMD K&L Biometrics team President Dr. Tiepu Liu, Associate Director of Statistical Programming Dr. Chttp://www.fountain-med.com/news.php?id=56www.fountain-med.comFMD Biometrics team was excited to participate in the 2017 CDISC China Interchange conference held in Beijing on September 21 and 22.

 

The theme of this year’s meeting is “Empowering Innovation through Standardization” that sums up very well what’s going on in China in the pharmaceutical industry and regulatory policies. As China joins ICH and brings up processes and standards to coordinate efficient global pharmaceutical product development and regulatory review, many opportunities come up, thus CDISC standardization becomes a critical and timely hot topic.

 

During the conference, FMD’s biometrics leaders shared our experiences in this subject area. Dr. Tiepu Liu, President of Global Biometrics, presented history and practice of regulatory guidance in adopting CDISC standards. Chao Wang, Associate Director of Statistical Programming, shared experience in implementing Define.XML in China studies. The speakers shared their insights in implementing CDISC in NDA/BLA submissions.

 

CDISC, Clinical Data Interchange Standards Consortium, as a global, nonprofit organization, develops data standards to streamline clinical research and enable connections to healthcare. Ever since the US FDA planned and later requires data submission for regulatory review and approval, standardizing data format for submission has become a major focal point for sponsors. Recently China FDA has recommended data submission for product reviews and CDISC standards will play a major role in submission format to expedite review time and improve quality.

 

Major benefits to implement CDISC standards include:

  • Fostered efficiency

  • Enhanced innovation

  • Facilitated data sharing

  • Increased predictability

  • Complete traceability

  • Improved data quality

  • Reduced costs

  • Streamlined processes

 

FMD has been a pioneer in adopting CDISC standard in data and analysis and delivery. We have been a gold member of CDISC since the very beginning of CDISC initiative. Our senior leadership team was intimately involved in the first draft of SDTM Implementation Guide and pilot project testing. Over the years, we have provided many training sessions to our global clients. FMD has established in-depth knowledge and hands-on experiences that will undoubtedly make important contributions in the coming years as China starts implementing CDISC standards in its electronic regulatory submissions and reviews.

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Webinar: Leverage the Regulatory Changes in China to Accelerate Global Drug Development Programhttp://www.fountain-med.com/news.php?id=64www.fountain-med.comFMD will host a webinar on how to leverage the regulatory reform in China to accelerate global drug development. Dr. Dan Zhang and Emil Fu will discuss the regulatory reform in China and the strategies biopharm companies can take to make your programs more efficient.

 

Click here to register the online event.

 

Title: Leverage the Regulatory Changes in China to Accelerate Global Drug Development Program

 

Time: Friday, October 5, 12 noon EDT

 

Background:

 

The regulatory regimes in China has been undergoing a significant overhaul.  These changes aiming to align the China system to the ICH standards is causing confusion and misunderstanding. To take full advantage of the new system in China, overseas compaines must plan early to include China in their global development plan to accelerate their product development cycle.

 

Our industry experts will explore the recent regulatory reforms in China including the new regulations on the acceptance of foreign data by the China National Drug Administration (CNDA) formerly the cFDA. They will focus on the impact on the biopharma industry. Audience will learn how to take full advantage of the reform to accelerate global development.

 

Dr. Dan Zhang, Executive Chairman of FMD, will discuss the impact of the recent regulatory reform in China. Among other strategic imperatives, Dr. Zhang will delineate the potentials to leverage these favorable changes to accelerate global drug development programs. Limited space is on a first-come-first-serve basis. Registration is open now.

 

Click here to register the online event.

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Webinar: Leverage the Regulatory Changes in China to Accelerate Global Drug Development Programhttp://www.fountain-med.com/news.php?id=65www.fountain-med.comFMD will host a webinar on how to leverage the regulatory reform in China to accelerate global drug development. Dr. Dan Zhang and Emil Fu will discuss the regulatory reform in China and the strategies biopharm companies can take to make your programs more efficient.

 

Click here to register the online event.

 

Title: Leverage the Regulatory Changes in China to Accelerate Global Drug Development Program

 

Time: Friday, October 5, 12 noon EDT

 

Background:

 

The regulatory regimes in China has been undergoing a significant overhaul.  These changes aiming to align the China system to the ICH standards is causing confusion and misunderstanding. To take full advantage of the new system in China, overseas compaines must plan early to include China in their global development plan to accelerate their product development cycle.

 

Our industry experts will explore the recent regulatory reforms in China including the new regulations on the acceptance of foreign data by the China National Drug Administration (CNDA) formerly the cFDA. They will focus on the impact on the biopharma industry. Audience will learn how to take full advantage of the reform to accelerate global development.

 

Dr. Dan Zhang, Executive Chairman of FMD, will discuss the impact of the recent regulatory reform in China. Among other strategic imperatives, Dr. Zhang will delineate the potentials to leverage these favorable changes to accelerate global drug development programs. Limited space is on a first-come-first-serve basis. Registration is open now.

 

Click here to register the online event.

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