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Perceptive Informatics ESTABLISHES ALLIANCE WITH AG MEDNET

TO BRING GReATER EFFICIENCY anD QUALITY TO MEDICAL IMAGING-BASED TRIALS

Marshall Edwards Accelerates Study Timeline and Experiences Cost Reduction

through Perceptive Alliance with AG Mednet

Boston, MA, February 4, 2009 — Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced it has established an alliance with AG Mednet, a global diagnostic imaging network, to bring greater efficiency to the electronic transport of medical images and a higher level of quality to imaging data. Medical imaging data collected globally from clinical sites will be delivered to Perceptive Informatics through AG Mednet’s secure, web-enabled network.
Through a more efficient image acquisition and collection process, which eliminates medical image file shipments, Perceptive’s alliance with AG Mednet is focused on helping sponsors to realize cost savings. Due to the high image quality available through AG Mednet’s digital delivery system, Perceptive is able to help sponsors decrease the time required for image reviews since less time will be spent on queries and data reconciliation with sites.
“As sponsors increasingly rely on medical imaging to assess new compounds, accelerate development, and decrease the cost of getting treatments to market, we are focused on enhancing the speed of medical image delivery and the quality of associated data,” said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics. “Perceptive’s alliance with AG Mednet is representative of our goal to help clients raise the productivity of the clinical development process to a new level through our eClinical platform.”
Abraham Gutman, President and Chief Executive Officer of AG Mednet, added, “We are pleased to combine the routing power of the AG Mednet network with the leading medical imaging capabilities of Perceptive Informatics to help streamline medical image collection and review for each trial, and together provide tangible benefits to sponsors.”
 
“Marshall Edwards Inc. is currently working with Perceptive Informatics and AG Mednet on a medical imaging-based study with a focus on increasing efficiencies and reducing costs. We are pleased with the
accelerated timeline possible for this study brought by the value of this alliance, as well as many other benefits such as initial cost reductions for courier services related to image delivery,” said Patti Rossi, Pharm. D., Vice President of Clinical Operations, Marshall Edwards, Inc., a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics and subsidiary of Novogen.
 
AG Mednet, which provides the largest HIPAA and 21 CFR Part 11 compliant image transport and exchange network, routes a broad range of medical imaging modalities, including CT, MRI, ultrasound, PET and digital x-ray. The dedicated, carrier-class network has a robust fiber-optic infrastructure to handle uncompressed files of any type for any size study. The automated system, which enables the secure, seamless electronic transfer of study data from sites to Perceptive’s central image repository, enhances site compliance while providing detailed reporting for regulatory requirements.

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Latest from Russia

SynRG opens business development division in the USA

On Septrember 10, 2009 Contract Research Organization Synergy Research Group (SynRG) announced company’s business development center of gravity move to the USA: new Director of Business Development will be located in North Kingstown, RI. According to company’s top management, this action will allow to attract potential sponsors – small and mid-sized American pharmaceutical and bio-technology companies, for whom issues of time reduction for new drug launch are essential in the current economic situation.
”Best-in-class companies don't view a downturn as a period in which to simply survive. They see opportunity in the uncertainty and navigate through the storm with investments in growth strategies that not only help them carry on, but also prepare them to move quickly once the economy recovers,” says David Frigstad, Chairman of Frost & Sullivan.
“To catapult ahead of the competition, companies should continue to invest in growth strategy development and seek insights and guidance from trusted sources," adds Frigstad. "After all, if they don't, their competitors will."
By opening business development in the USA, SynRG follows exactly this approach. The company is positive that in the current situation Russia will be even more attractive in terms of clinical trials for American small and mid-sized sponsors. To this end SynRG does its best to utilize opportunity presented by the crisis – to make Russia one of the leaders in clinical trials marked worldwide.
“We have always emphasized that one of the strategic goals set by SynRG is enhancing of research and investment attractiveness of Russia for foreign sponsors, so business development in the USA is a natural step along this strategic line”, - says SynRG CEO Igor Stefanov. “We spent quite some time interviewing candidates and conversing with the finalists, and now I am happy to introduce our new Director of Business Development, Anna Ravdel”.
Anna Ravdel has graduated from the University of Manchester with an MBA degree, and worked as a marketing and sales director in various international companies. Prior to joining SynRG, Anna had worked as a Director of Business Development at Evidence Clinical and Pharmaceutical Research (Russia/USA) and at a global CRO Worldwide Clinical Trials.
 “I have known SynRG for a long time by their quarterly magazine “Orange Book” summarizing information on clinical studies conducted in Russia. Deep knowledge of local specifics and regulatory requirements as well as a large number of medical institutions participating in clinical trials conducted by SynRG and a wide net of CRAs working in different cities allowed this company to quickly reach one of the leading positions in the Russian clinical trial market. I have no doubt in SynRG further success, and I will be happy to bring my experience and enthusiasm to the continuous advancement of the Synergy Research Group”, - says Anna Ravdel. 
 “We have conducted serious preliminary work in document flow optimization on the stage of RFP receipt and preparation of study proposal. This will allow us to substantially cut response time and receive competitive advantages in the future bids. We have already granted Anna access to our client database – and this is more than 300 prospects. However, our plans are going further – until the end of the year we are planning to open Ukrainian office and, probably, a virtual office in Prague, as more and more our clients are interested in our presence from Eastern European countries to Kazakhstan on a regional level.
Synergy Research Group (SynRG™) is a leading Russian Contract Research Organization successfully working on the territory of Russia and CIS countries since 2002. SynRG™ provides our clients with the board specter of clinical trial services for Russian and foreign pharmaceutical and biotech companies. SynRG™ also operates central drug and clinical trial materials depot in Moscow. Currently Synergy Research Group is represented in Russia (Moscow, St. Petersburg, Novosibirsk, Ekaterinburg, Perm, Rostov-on-Don), and also in Kazakhstan (Almaty and Astana). Through its partners, SynRG also can conduct clinical studies in Ukraine, Belorussia, Eastern and Western Europe, India, Pakistan, and the USA. The company Headquarters are located in Moscow, Russia.

Stiefel Laboratories Implements Medidata Rave® to Achieve Immediate Cost Savings across Global Clinical Studies
 
Medidata Solutions, a leading provider of clinical trial solutions, today announced that Stiefel Laboratories has selected Medidata Rave® as the central component of its clinical data management process. Medidata Rave has already helped Stiefel to significantly reduce upfront study costs and expanded use of this electronic data capture (EDC), management and reporting solution is expected to play a key role in helping Stiefel to achieve a projected 35 percent reduction in data management costs during the next three years.
 
Stiefel, a global pharmaceutical company headquartered in the United States, develops skin care products used by millions of people each year in more than 100 countries. Prior to implementing Medidata Rave, Stiefel conducted its clinical trials using paper-based systems. In order to streamline work processes across trial teams worldwide, the company decided to implement an electronic system for data capture. Stiefel’s team opened its search for an EDC system with broad functionality that could serve as the end repository for all clinical data and easily export data directly into its SAS environment. After a formal evaluation of nine EDC vendors in March 2008, Medidata Rave stood out to Stiefel among competing solutions as the system that worked best in a straight-to-SAS environment and could also be hosted off-site while supporting a knowledge transfer of the database build functionality.
 
“We chose Medidata Rave based on a range of criteria, including ease-of-use for sites and monitors, simple and fast study start-up, zero-footprint and browser-independent capabilities, no requirement for a back-end CDMS, availability of real-time, on-demand tools and Medidata’s dedication to customer support,” said Gavin Corcoran, M.D., chief scientific officer at Stiefel. “As we evaluated systems, we were also impressed with Medidata’s continued expansion of Rave’s features and functionality. We expect that Medidata will continue to invest heavily in further innovation and product development, which will only help us down the road.”
 
With help from Medidata’s Professional Services staff and a contract research organization (CRO), Stiefel launched its first trial using Rave in less than 10 weeks. By leveraging Medidata’s flexible and interactive implementation process, Stiefel was able to reduce study start up time from an average of 10 weeks to an average of six weeks. With three Rave studies already in place in the US, Canada, Germany, Iceland and Belize, Stiefel has achieved a reduction in data management costs and expects those savings to increase as it starts to build out global libraries.
 
Stiefel plans to have six Rave studies up and running by March 2009, with a long-term goal of deploying 35 trials during the next three years. The company is using Medidata Rave’s eLearning modules to ensure consistent training across globally diverse sites and studies, and also intends to explore leveraging Rave to enable a seamless integration between its clinical trial management system (CTMS) and integrated web response system (IWRS) in an effort to maximize the value of its current and future technology investments.
 
“By tightly linking these systems, we can start to establish a data ‘pipeline,’ where data is entered once and then pulled to all other systems, further improving efficiencies and making relevant data available to the entire clinical team as quickly as possible,” added Corcoran.
 
“We are very pleased that Medidata will play a key role in supporting Stiefel’s continued commitment to advancing dermatology and the development of skin care treatments around the world,” said Tarek Sherif, CEO, Medidata Solutions. “Stiefel’s selection of Medidata Rave speaks not only to our ongoing dedication to product innovation and customer support, but also to our mission of helping sponsors attain operational excellence in clinical research.”
 
About Medidata Solutions Worldwide
 
Medidata Solutions (www.mdsol.com) is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies – including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation – Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers reduce trial cycle times, achieve early visibility to reliable clinical data, and maintain strict fiscal responsibility, while safely accelerating the process of bringing life-enhancing treatments to market.
 
About Stiefel Laboratories, Inc.
 
Stiefel Laboratories is enthusiastically committed to advancing dermatology and skin science around the world. The company's deeply-rooted dedication and drive for innovation along with its sole focus on dermatology has led Stiefel to become the largest independent dermatology company in the world. In addition to more than 30 wholly-owned subsidiaries, six manufacturing plants and a global research and development network, Stiefel's most valuable asset is its global network of nearly 4,000 driven associates.
 
By combining expertise, knowledge and imagination, Stiefel delivers exceptional ethical, over-the-counter and aesthetic products to its customers in more than 100 countries around the world, ultimately providing a unique Stiefel skin health experience. Stiefel also is committed to improving today's treatments and exploring tomorrow's innovations. Each year, the company invests more than $100 million USD in developing the most advanced skin health solutions. Additionally, Stiefel supplements its research and development efforts by seeking strategic partnerships and acquisitions around the world. To learn more about Stiefel, visit www.stiefel.com.