news

FOR IMMEDIATE RELEASE
Media Contact – Bernie Clark
bernie.clark@clearstonelabs.com
Tel: +1 610-924-5336
 
Eli Lilly and Company presents Clearstone Central Laboratories with 2010 Global Supplier Award
 
Annual award recognizes business partners who are able to deliver superior service and results that provide Lilly with a competitive edge
 
Indianapolis, Indiana – 12 April 2011 – Clearstone Central Laboratories, a leading global provider of central laboratory services for late-stage clinical trials, has been selected by Eli Lilly and Company for their 2010 Lilly Global Supplier Award.  This award was presented to Clearstone executives today in a recognition ceremony at the company’s headquarters in Indianapolis.
 
The Lilly Supplier Award for Excellence recognizes suppliers who have achieved superior results providing Lilly with a competitive edge in 2010.  Nominations were submitted by internal procurement and clinical study teams that could demonstrate how a supplier had a measurable impact on Lilly corporate priorities through the delivery of exemplary quality, service, speed, total cost reduction, and other value adds.
 
“We were honored to be nominated for this prestigious award, and are obviously thrilled to accept the prize from our business partners at Lilly”, said Clearstone CEO Lewis Cameron.  “This kind of recognition speaks volumes as to our relationship and track record with Lilly, but also shines a light on our amazing employees around the world who make a difference for our clients each and every day.  We accept this reward on their behalf and look to further strengthen such relationships by continuing to deliver exceptional service and results for our clients.”
 
###
 
About Clearstone
Clearstone Central Laboratories is the largest and most experienced private company exclusively focused on providing central lab services to support late-stage drug development with accurate and timely test data.  With over 20 years of experience in mature and emerging markets, we offer world-class laboratory testing, project and data management, and logistical support to leading pharmaceutical and biotech companies around the world.  Clearstone’s 500-member global workforce delivers these services from our wholly-owned CAP-accredited laboratories and global kit production facilities in Beijing, Hamburg, Paris, Singapore and Toronto. We also own and operate APOLLO CLPM™ – the leading proprietary central laboratory protocol management system.  For more information, visit our website at www.clearstonelabs.com.
 
 
 
Regards,
 
Bernie Clark
Director, Global Marketing & Communications

Clearstone Central Laboratories
PO Box 103
Oaks, Pennsylvania 19456 USA
Phone: +1 610-924-5336
Mobile: +1 484-919-8022
bernie.clark@clearstonelabs.com
www.clearstonelabs.com

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.

Valerie Palumbo Joins PharmaNet as Senior Vice President, Corporate Quality Assurance

Princeton, NJ – April 28, 2011 – PharmaNet Development Group, Inc., a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, announced today that Valerie Palumbo has joined the Company as Senior Vice President, Corporate Quality Assurance.

“We are very pleased to have Valerie join us,” said Thomas Newman, MD, President, PharmaNet Development Group. “Valerie brings deep experience in developing global programs that will enhance our quality processes and augment our existing compliance programs.”

Ms. Palumbo has more than twenty years of experience in the development and implementation of quality assurance programs in the FDA-regulated drug and medical device industries. Her experience includes oversight of pre-clinical, clinical, and clinical supplies manufacturing activities. In addition, Ms. Palumbo has significant experience in the globalization of policies and procedures that drive company-wide compliance, and in the implementation and enhancement of computer system validation and 21 CFR Part 11 compliance processes.

About PharmaNet

PharmaNet Development Group, Inc., a recognized leader of global drug development services to the pharmaceutical, biotechnology, generic drug, and medical device industries, provides comprehensive capabilities in Phase I-IV clinical development, bioanalytical and bioequivalence services, regulatory, staffing, and therapeutic solutions. For the applied knowledge and intelligent solutions needed to accelerate drug development programs of all sizes around the world, PharmaNet works for you. For more information, please visit www.PharmaNet.com.

Contact: Anne-Marie Hess, Vice President, Marketing and Corporate Communications
Phone: +1 609 951 6842
Email: ahess@pharmanet.com

FOR MEDIA INFORMATION: 
Simon Vane Percy
Vane Percy & Roberts
Office: +44 (0)1737 821 890
Mobile:  (0)7710005910
Home: +44 (0)1883 724505
(e) simon@vanepercy.com
FINAL
SYNEXUS ACQUISITION STRENGTHENS ITS EUROPEAN PLATFORM INCREASING TOTAL NUMBER OF SITES TO 26
Synexus has agreed to acquire Leipzig based ClinPharm and will complete the acquisition in January 2010. This deal will increase the number of Synexus’ Dedicated Research Centres to 26 in nine countries, thus significantly strengthening its European reach and further reinforcing its position as the global leader.
Synexus is the world’s largest multi-national company entirely focussed on the recruitment and running of clinical trials at its own Dedicated Research Centres. While it has a network of research centres in Central and Eastern Europe, this acquisition will add eight research centres in Germany.  It will strengthen Synexus’ Central and Eastern Europe portfolio of centres in Poland, Hungary and Bulgaria with additional sites in Austria and Ukraine, enhancing its platform in an area of significant importance to its clients. Synexus now has research centres in Western, Central and Eastern Europe, South Africa and Asia. 
Synexus’ clinical trial patient recruitment proposition has gained considerable momentum over the past couple of years as the pharma industry has realised that its ‘new model’ really does live up to its promises of being able to access greater patient populations at an expedited rate for a lower total cost, while ensuring consistently high quality clinical outcomes. 
The ClinPharm acquisition will increase Synexus’ total patient population reach to over 30 million patients; an increase of 50 per cent globally and 100 per cent across Europe. No other patient recruitment organisation can compete in terms of size or scale. ClinPharm also brings considerable additional therapy area experience to Synexus.
This acquisition follows a period of considerable growth for Synexus. It has traded in line with expectations, experiencing substantial growth in revenues, profits and order book value over the past three financial years and over a 100 per cent increase in net profit in the last financial year.  In addition to organic growth, fuelled by the interest in its unique model, acquisitions are a key component of Synexus’ growth strategy. This rapid expansion has been made possible by the financial support of private equity fund Lyceum Capital, who backed a management buyout of the business in 2007, enabling it to de-list from AIM. Working with Lyceum, the management team has since pursued an aggressive growth strategy to help Synexus capitalise on increasing international demand for the professionalisation of recruiting and running clinical trials at customised research centres, staffed by full-time investigators. This has included two previous complementary acquisitions.

Commenting on the deal, Synexus Chief Executive Michael Fort said: “The Synexus concept has been proven. We made, what were perceived to be, bold statements about our capabilities. Our work with some of the world’s leading pharma companies has, however, now convinced the market that we do represent the new way of finding patients and running clinical trials at Dedicated Research Centres. In order to keep pace with the market’s demands it is necessary for us to increase our infrastructure and patient reach. ClinPharm provided the ideal opportunity as they have considerable presence in Western, Central and Eastern Europe and also understand the way we work.”
The deal will be finalised in January 2010 after ClinPharm’s year end. ClinPharm’s founding CEO, Hans-Detlev Stahl MD, Ph.D. (Melb). F.R.A.C.P joins Synexus as European Medical Director. Dr Stahl has considerable experience both clinically, having worked as a Consultant Specialist in Rheumatology and Clinical Immunology and, more specifically, in clinical trials having worked as a Principal Investigator and Co-ordinating Investigator for over 10 years. In addition he is widely published with over 50 scientific publications and two textbooks bearing his name. 
Dr Stahl commented: “It was a natural fit to team up with Synexus.  We know each other very well and our geographic coverage is totally complementary. Together we are much stronger and I look forward to helping the new company with further expansion which delivers real benefits to our clients in pharma.”  
Dr Helena Sigal, currently ClinPharm’s Director of Operations, will become Synexus’ Country Manager in Germany. The Austrian and Ukrainian clinics will join Synexus’ existing CEE region reporting to Dr Christian Tueni, CEE Regional Director. Both Drs Sigal and Tueni will report to Jane Restorick, Snr VP International Operations.

Synexus notes
Synexus® headquartered in Manchester, England, is the world’s largest multi-national company dedicated to the recruitment and running of clinical trials at its own research centres across the globe on behalf of its pharmaceutical, biotech and CRO clients.  Synexus now has 26 Dedicated Research Centres across the UK, Germany, Austria, Poland, Hungary, Ukraine, Bulgaria, India and South Africa staffed by full-time GCP-trained investigators.
The traditional way of recruiting for clinical trials through individual doctors is still by far the most common method, despite the fact that each doctor only recruits an average of five patients per study and more than 40 percent recruit one or less.  This incredibly costly model remains the norm.

FOR IMMEDIATE RELEASE

Emily Clarke – Marketing Officer
Tel: +44 (0) 8456 777001  Fax: +44 (0) 8456 777002
Email: emilyc@woodleyequipment.com

WOODLEY EQUIPMENT LAUNCH THEIR NEW AND IMPROVED POINT OF CARE PRODUCT RANGE
Woodley Equipment have launched their new and improved Point Of Care range for laboratory diagnostics and specialist technical support.

Woodley Equipment Company Ltd have been supplying equipment to the Clinical Trials industry for over 20 years. Woodley specialise in Point Of Care (POC) diagnostic solutions and have recently expanded and developed their product range and supporting services. Woodley now employ several Biomedical Scientists who specialise in Haematology, Biochemistry and Point of Care devices for all disciplines, a Medical Electronics Manager and Service Engineers to enhance the supporting service associated with the newly expanded POC product range. 
POC testing can be implemented using disposable testing kits, such as dipsticks and cassettes, handheld analysers and monitors, or small benchtop analysers, all of which require little or no maintenance. This equipment can be applied to a range of different tests such as blood gases, electrolytes, coagulation, urinalysis, lactate, glucose, cholesterol, pregnancy assessment and drugs of abuse testing, covering a variety of fields including biochemistry, haematology and virology. Woodley are proud to be offering an extensive range of analysers, but in addition, Woodley will always source and supply any additional POC equipment required to individual specifications. 
Woodley Equipment can supply POC equipment and reagents to sponsors and CROs on a global scale. It is essential that any company supplying POC devices is suitably equipped to provide an efficient and reliable service as this is a highly specialised area of expertise. Woodley’s Biomedical Scientists have a high level of knowledge and experience and are on hand to provide global training and advanced technical support. Woodley have their own in-house service department with qualified engineers to ensure all their equipment is fully calibrated and maintained to the highest standards. Their experience in logistics is also essential to maintain the supply of sensitive reagents worldwide. Reagents need to be kept at correct stable temperatures throughout the shipping process, so it is vital that Woodley have the experience to move equipment and reagents across borders and through difficult countries whilst ensuring the cold chain is maintained and documented.

Woodley Equipment have extended their range of POC devices to now include:
Glucometers, Lipid analysers, Pregnancy assessment, Alcoholmeters, Coagulation
analysers, Haematology analysers, Biochemistry analysers, Blood gas and electrolyte
analysers, Drugs of abuse assessment, Urinalysis, Haemoglobin analysers, White blood
cell count analysers, Micro albumin analysers and Plasma/Low Hb photometers.

Woodley’s new and improved POC service can provide benefits to clinical trials by acting as a single source for all your POC requirements. Woodley provide a full service from initial enquiry through to final collection, they are with you every step of the way. They will organise all deliveries, collections, training, technical support and provide advice to any number of sites across the globe, bringing you pure peace of mind when it comes to your equipment solutions.

#  #  #

If you would like further information on Woodley Equipment Company Ltd or their new and improved Point Of Care range please call, visit www.woodleyequipment.com/clinicaltrial or email Emily Clarke: +44 (0) 8456 777001 or emilyc@woodleyequipment.com

Press Release: Date – 17 Feb 2010

Almac Launches New STEMS System to Transform Temperature Controlled Shipment Monitoring in Clinical Trials

Novel technology saves time and reduce costs in clinical studies

“Almac Clinical Services marked the start of 2010 with the official launch of a new state-of-the-art web-based, Shipping Temperature Electronic Monitoring System - stems. Unique to the pharmaceutical and biotech industries, this latest addition to the Almac services portfolio is set to revolutionise the management of temperature controlled shipments within the clinical trial industry. ‘

Temperature excursions can inhibit the clinical supply chain, resulting in crucial investigational products being delayed or quarantined and not made available for immediate use at the study site. Excursions can occur at any point in a global supply chain and often arise as a result of multiple uncontrollable factors 
  
Upon download, Almac’s Shipping Temperature Electronic Monitoring System – stems, equips clinical supply professionals with immediate visibility over all crucial shipment temperature reports. This enables users to make instant decisions 24/7 on their clinical supplies without the need for monitor returns or faxing of results.
 
Stems reduces any quarantine time for clinical supplies at study sites, saving both time and money for a global clinical study.

stems is the latest addition to the Almac services portfolio for temperature controlled clinical supplies. Alongside the Group’s Specialist Temperature Controlled Team, and customised shipping unit systems, this new technology delivers the following key features:

Key Features
•	100% shipping temperature reports -  allowing root cause analysis for process improvements saving time & financial resources in large global trials
•	Instant reporting enabling near zero quarantine time – improved inventory management whilst  saving time and reducing costs
•	Fully-validated system – compliant with 21 CFR Part 11 requirements
•	No return shipments required for devices, saving time and reducing expenditure
•	Fully compatible with a range of browsers and requires little training
•	Automated email notifications sent to predefined users
•	Complex multiple alarm system programmed to match drug temperature requirements

This latest launch also coincides with a new Label Approval System (LAS) – a unique workflow-based label approval management system. LAS gives users full online review, amendment, traceability and control functionality regardless of geographic location.

Martin Lamb, Vice President of Global Business Development, Almac Clinical Services commenting on the launch of the new system: “I am delighted to announce the launch of our new Shipping Temperature Electronic Monitoring System - stems. We have experienced rapid growth in the volume of our controlled temperature shipments in the past few years. Improving visibility and performance in this area is a key goal for Almac, our clients and regulators alike, so the introduction of new, innovative tools has been a core part of our business strategy. By helping our clients achieve these goals, stems will be of major interest to Pharmaceutical and Biotech clients.’

If you would like further information on the system or would like to view a demo please visit www.stems.almacgroup.com .

Contact: 
Aileen Murphy							
aileen.murphy@almacgroup.com			
Tel: +44(0)28 3836 2436

An online demo can be viewed at the following link:

www.stems.almacgroup.com .

Media Enquiries:
Tristan Jervis or Alex Heeley on: 0207 861 3019 or 0207 861 3030. E-mail: t.jervis@defacto.com.

About Almac 
 
Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,400 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”.  US operations are based in Pennsylvania, North Carolina and California.  Construction of the company’s new $112m North American Headquarters in PA started in July 08 and will be completed in 2010.
For more information about the Almac Group, please visit www.almacgroup.com or e-mail info@almacgroup.com.

SCA COOL LOGISTICS ANNOUNCES
GLOBAL PARTNERSHIP WITH MINNESOTA THERMAL SCIENCE

New Partnership Expands Product Line and Availability in the U.S

Leighton Buzzard U.K – 2010 –SCA Cool Logistics a European market-leader of temperature-controlled packaging would like to announce the strategic partnership with  Minnesota Thermal Science (MTS), an international provider of solutions for the safe transportation of temperature sensitive pharmaceutical, blood and biologic products. The partnership will allow and SCA Cool Logistics and MTS to expand their operations globally, as well as offer a complete range of products to all clients.

Through this partnership, SCA Cool Logistics will provide sales and distribution of the MTS Credo® product line throughout Europe and other parts of the world, providing their clients a broader product offering, quicker more efficient delivery and local customer support. In turn, MTS will expand its product offerings to include SCA Cool Logistics’ leading Sherpa product line and the new ZeoCool product rage. By offering complimentary products, clients will now have the opportunity to work with one provider to create a complete temperature packaging solution that will address all of their needs.

Nick Walsh, Sales Manager – Strategic Accounts commented:

“As the demand from the market increases for a wide range of cost efficient, high performance solutions that can be supplied on a Global basis, SCA Cool Logistics and MTS are uniquely placed to provide a complimentary and highly innovative product offering both to our existing international customer base and those in a diverse number of new market segments”

“MTS has consistently demonstrated its leadership in delivering sophisticated cold chain packaging solutions and is excited about the opportunity to expand globally with Cool Logistics,” said Karl Schlenker, Vice President of Strategic Business Development for MTS. “The ability to deliver a full range of products from local distribution will shorten lead times and reduce delivery cost to our clients. Because MTS and SCA Cool Logistics currently serve a number of mutual clients, the partnership will not only enhance our relationships with them, but also result in more account coverage and deeper global relationships.”

SCA Cool Logistics founded in 2000, designs, qualifies, manufactures and supplies temperature controlled packaging solutions with the largest test facility in Europe. The company focuses predominantly, on Pharmaceutical, Biotech, and Clinical Research industries.

The company was acquired by SCA packaging in 2006 forming part of the SCA group.
SCA is a global consumer goods and paper company focusing on: personal care products; forestry products; tissue and packaging. With Global sales of 11 billion Euros, operations in 90 countries SCA are ranked among the top 100 most sustainable companies in the world.

To learn more about SCA Cool Logistics and its products, visit www.sca-cool-logistics.com

Contact: Fred Dominguez
Tel: (949) 428-6645
Email: fred.dominguez@clindatrix.com

ClinDatrix, Inc. Deploys Oracle® Health Sciences Suite

Irvine, CA – March 15th, 2010

ClinDatrix announced today that they have completed the IQ/OQ/PQ validation for Oracle Clinical, Oracle Remote Data Capture 4.5.3 and Oracle Thesaurus Management.  ClinDatrix is now offering its clients the robust, highly reliable and scalable Oracle Health Sciences Suite of applications.  The company will use these tools to broaden its current world class quality data management and clinical services in the pharmaceutical, biotechnology, and medical device industries.   ClinDatrix is currently servicing 6 clients and 21 global clinical trials.  This month marks ClinDatrix’s 8th year in business.

Implementing, the industry’s leading clinical data management system will facilitate ClinDatrix’s current global expansion into Phase III clinical trials.  The company is launching two Phase III EDC trials this month, for two different sponsors.  Utilizing Oracle Health Sciences suite extends ClinDatrix’s clinical trial services by providing the sponsor with electronic data capture.  The company has created customized self-paced online training for investigator sites and is providing 24/7 technical support.  Using Oracle Clinical and Oracle Remote Data Capture Onsite 4.5.3 will meet the needs of the sponsor while providing site personnel a simplified user interface.  ClinDatrix plans to increase trial staff efficiency by allowing the global investigator sites to record, store, and help manage clinical data. Discrepancy management is eased by providing immediate validation checks, batched validation checks and remote monitoring.  Oracle Thesaurus Management System (TMS) facilitates rapid coding of medical terminology and supports all dictionaries required by international regulatory authorities.  Oracle Adverse Event Reporting System (AERS) is a comprehensive solution for product safety monitoring and compliance.  Using these tools will expand services and allow the company to continue to provide clients solutions to help manage all intricacies of their clinical trials.

”Oracle Clinical and Oracle Remote Data Capture provide an integrated EDC solution that uses the same database for either paper or EDC data submissions.  This is a strong feature from a Data Management perspective”. Louise M. Murphy, PhD, MBA, President and CEO

About ClinDatrix
ClinDatrix is committed to providing world class, full service clinical research capabilities to the biotechnology, medical device, and pharmaceutical industries. Partnering with its clients, ClinDatrix uses a personalized approach to apply knowledge and experience to the goals of managing, monitoring, collecting, validating, analyzing, reporting, and delivering quality clinical data with efficiency and accuracy.  ClinDatrix has been in business 7 years and has successfully managed over 100 studies.  For more information, please visit http://www.clindatrix.com.

PHARMAVIGILANT ENHANCES eTMF SYSTEM WITH GROUNDBREAKING FUNCTIONALITY;

COMPETITIVE GAP WIDENS

Company Unveils I-Vault 2.5 for Enhanced Reporting, Tracking and E-mail Functionality

WESTBOROUGH, Mass., July 27, 2010 – PharmaVigilant, a clinical trial technology provider, today unveiled I-Vault 2.5, the enhanced version of its industry-leading electronic Trial Master File (TMF) system.  This new version offers easier access to the critical trial data that sponsors need to make important decisions related to their clinical trial quickly and effectively.  I-Vault 2.5 improves usability, administration and notification capabilities for seamless site startup, site closeout and IRB submissions, drastically reducing costly trial delays and roadblocks.

By offering unlimited rights and roles and enabling global scalability, PharmaVigilant’s enhanced eTMF system offers improved accuracy and analysis of trial data.  Flexibility is key, particularly for complex trials, and I-Vault 2.5 allows each sponsor to determine which trial documents they wish to collect and how they would like them organized.  This level of customization makes it easier for sponsors to adhere to study startup and closeout timelines while saving time by making disparate data easier and faster for sponsors to find.

“Sponsors need to convert their trial master files yesterday, so the need for robust, full-function products that can scale globally are in demand in the market.  PharmaVigilant is committed to aggressive investments in our technology, and as a result we are widening the gap between ours and our competitors’ offerings,” said James DeSanti, founder and CEO of PharmaVigilant.  “With this newest version of I-Vault 2.5, our clients can better isolate trial inefficiencies and achieve significantly higher quality and cost savings.  PharmaVigilant continues to produce innovative and unique technologies that are changing the landscape of the clinical trial industry.”

The newest version of I-Vault 2.5 includes key features such as:

·         Enhanced e-mail notifications – allows trial sponsors to subscribe all users of a certain role to a notification.

·         Enhanced document tracking capabilities – automatically send e-mails to designated users when an action has occurred on the select document they are tracking.

·         Improved reporting functionality – users can view their documents in charts broken down by status, site or type, improving transparency and organization of files.

·         Separated signed and approval status – provides increased visibility for users.

PharmaVigilant offers a full suite of clinical trial technology offerings including Electronic Data Capture (EDC), data warehousing, study building (I-Builder 2.0), Electronic Trial Master File System (eTMF), Remote Source Document Verification (rSDV), study administration and an automated site payment system.  PharmaVigilant focuses on Phase I-IV clinical trials, registries and other post-marketing studies. The technology has supported more than 200,000 patients in 14 countries across North America, South America, Europe, and Asia and continues to expand rapidly.

Medidata Solutions CEO Tarek Sherif and President Glen de Vries Named
Ernst & Young Entrepreneur Of The Year® 2010 Metro New York Area Award Winners

Clinical Technology Company Co-founders Honored for Excellence in Business Services

NEW YORK, N.Y. – June 17, 2010 – Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Tarek Sherif, CEO, and Glen de Vries, President, have been honored with the Ernst & Young Entrepreneur Of The Year® 2010 Award for the Metro New York area. Sherif and de Vries were selected from nearly 70 executive nominations across various industries for demonstrating extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses and communities.

Ernst & Young’s panel of independent judges consisting of entrepreneurs and prominent leaders from academia, business and the media honored Sherif and de Vries for building a truly collaborative, sustainable and growth-oriented business.

With their vision of bringing new efficiencies to the clinical research process through advanced technology solutions, Sherif and de Vries have guided Medidata through its rapid growth to establish one of the largest free-standing software companies in New York City and one of the two industry leaders in electronic clinical data collection and management solutions. Together they have grown Medidata by offering a compelling business story based on strong customer commitments, proven technology and solid execution.

“Initiative and resourcefulness are two components that make any entrepreneur successful, and those factors have definitely played a large role in selecting this year’s winners,” said Jodi Burns, Ernst & Young LLP Entrepreneur Of The Year Program Director for Metro New York. “In taking a start-up to IPO, during a recession no less, Tarek Sherif and Glen de Vries have demonstrated a strong technology vision and business model that will no doubt continue to propel the company forward.”

“Glen and I are truly honored to be recognized by Ernst & Young alongside many of New York’s entrepreneurial visionaries,” said Sherif. “We realize this award also honors all of Medidata’s employees, who, through hard work and extraordinary execution, have built our successful company by listening to customers, understanding their needs for improved clinical development processes, and delivering innovative technology to expedite their trials successfully.”

The award was presented at the Ernst & Young Entrepreneur Of The Year 24th anniversary gala event at the New York Marriott Marquis on June 15. Sherif and de Vries are now eligible for the national Ernst & Young Entrepreneur Of The Year award, which will be announced at the annual awards gala in Palm Springs, California on November 13, 2010. The awards are the culminating event of the Ernst & Young Strategic Growth Forum, the nation’s most prestigious gathering of high-growth, market-leading companies.

About Ernst & Young’s Entrepreneur Of The Year® Awards Program
Ernst & Young’s Entrepreneur Of The Year® is the world’s most prestigious business award for entrepreneurs. The award makes a difference through the unique way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, Ernst & Young Entrepreneur Of The Year® celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 135 cities in 50 countries.

Ernst & Young refers to the global organization of member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young LLP is a client-serving member firm of Ernst & Young Global Limited located in the U.S.

About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com

ClinStar Expands to US

San Francisco, CA (June 09, 2010) – ClinStar, a leading Western CRO in Russia, Ukraine, Belarus and the Baltic States, announced its first steps in adding clinical operations capacity in the United States. ClinStar entered into contractual relationships with Mr. Stephen Fogelson, M.S. to assist ClinStar in running the US portions of the global studies for ClinStar’s Sponsors. This partnership will boost ClinStar’s geographical reach by adding US sites to the successful and well-established business in Russia, Ukraine and other parts of Eastern Europe.

On assignment with ClinStar, Mr. Fogelson will manage full spectrum of clinical activities in the United States including site identification, qualification, monitoring, project and site management, etc. Clinical operations will be carried out in accordance with ClinStar SOPs, harmonized with US regulations.

Mr. Fogelson is a distinguished expert in clinical research and development, with over 20 years of experience in the industry. For the last 5 years Mr. Fogelson has been providing extensive strategic and tactical consultancy services to pharmaceutical and biotech companies. Mr. Fogelson commented: “I am very excited about this opportunity. ClinStar clearly understands global needs of the industry with a great balance of cost, speed and quality.”

“I am very proud that ClinStar is entering its second decade with such a tremendous advancement,” said David Passov, President and CEO of ClinStar. “After providing our clients with 10 years of the highest quality of service and dedication in our regions, this expansion marks an important progress in our service offerings. By adding clinical operations capabilities in the US, ClinStar significantly enhances its abilities for servicing clients in need of full-range service offering for their FDA and EMEA registration studies. By expanding our capabilities into US, we will become a global provider while retaining ClinStar’s core value of local expertise, and we will continue to provide faster patient enrollment, extraordinarily high quality and unsurpassed focus on every client.”

ClinStar is now offering its clients a full-range of clinical trial solutions including clinical and regulatory affairs, medical monitoring, QA auditing, as well as study materials logistics, warehousing and distribution.

About ClinStar: ClinStar is one of the most prominent CROs in emerging markets of Eastern Europe and the Baltics, with 10 years of expertise in Phase I-IV clinical studies in multiple therapeutic areas. Headquartered in San Francisco, California, ClinStar manages studies from its offices in Russia, Ukraine, Belarus, and Estonia, with total staff of over 280 people. Its portfolio contains over 130 clinical trials conducted for US and European pharmaceutical and biotechnology companies. More information is available at www.clinstar.com.

Press Release 110215

INTERLAB (Munich, Germany, February 2011), the leading European central laboratory with global operations, again achieves a 2-digit growth in 2010 after a historically high in 2009.

Competitive, flexible and reliable services have resulted in seven additional master services agreements being signed in the last twelve months.

INTERLAB’s laboratory network with nine locations worldwide offers access to high volume facilities, large in-house test menus and enhanced knowledge of local and regional culture and regulations.

INTERLAB announces new lab facilities to open in Shanghai, China, mid 2011 which are to substitute the Beijing laboratory used in the last five years.
At INTERLAB senior project teams coordinate all global activities from their offices in Germany or USA. Regional project teams in Argentina, South Africa, Israel, India, Singapore, China and Australia follow harmonized SOPs and global QA standards.

iLAB-World is INTERLAB’s proprietary software developed and validated following 21CFR part 11. While flagging and blinding criteria of lab reports can be customized at no additional cost, the layout of lab reports is uniform worldwide. A single global database avoids the need of manual data entry and verification – a unique feature.
In order to ensure data comparability all lab facilities are periodically audited and cross-validated: certifications are available to our customers.

contact:
INTERLAB central lab services – worldwide GmbH
Dr. Hermann Schulz, MD
Chief Executive Officer
Bayerstr. 53, D-80335 Munich, Germany
Tel +49 89 741 3930
www.INTERLAB.de
info@INTERLAB.de

Medidata Solutions Introduces New Contracting Application to
Streamline Clinical Trial Site Recruitment Process

Grants Manager Contracting™ Reduces Overall Study Startup Time by
Making Clinical Trial Budget Negotiations More Efficient

NEW YORK, N.Y. – January 19, 2011 – Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today extended the Grants Manager® web-based budgeting application with a new Contracting module, enabling sites and sponsors to negotiate clinical trial site budgets directly online, eliminating the burden of managing hundreds of email messages and reducing budgeting cycle times. Trial managers will also be able to monitor site negotiation status by study, site or across the portfolio in real-time, bringing unprecedented visibility to the process of site recruitment.

Sponsors currently rely on Medidata Grants Manager for benchmark cost data to quickly and accurately develop site grant budgets. The new Contracting module provides a natural extension to the budgeting process by offering negotiating, reporting and management of contracting in an integrated, online environment.

“Grants Manager Contracting represents a significant opportunity to accelerate site recruitment by automating the arduous and manual back-and-forth between sponsors and sites during the clinical trial budget negotiation process, allowing sponsors to move seamlessly from planned budget to finalized site costs in less time,” said Lori Shields, vice president of Medidata’s Data Operations. “In managing to the overall budget, sponsors have been enthused with the visibility to real-time site negotiation data, including signaling the need for intervention if negotiations begin slipping against the project timetable or forecasted budget.”

Grants Manager Contracting is the newest member of an expanding family of Medidata products that help speed clinical trial start-up and improve management. Contracting budget plans can be developed internally within Grants Manager or imported by sponsors that prepare their budget with other tools. Selected sites can immediately review the proposed budget online in a format that assists rapid understanding and facilitates negotiation and agreement. This in turn leads to more rapid site enrollment and improved site satisfaction. Ultimately, Grants Manager Contracting reduces overall study startup time by eliminating current manual tracking methods, reducing reliance on emails and spreadsheets, providing managers visibility of rollout progress, and offering sites an easily understood format for budget review.