LIMSource News: What's New: January to February 2006

• QSI WinDocs Solution Offers Affordable, Comprehensive Document Control
• Informatics Grad Student Named First LabWare Fellow
• Collaboration Agreements Support FDA's Critical Path Priorities List
• Democrats Consider Legislation to Halt Labeling Preemption
• FDA'S New Labeling Rule Aims to Improve Drug Safety
• ARTEL and Caliper Life Sciences Announce Technology Partnership
• Bio-Rad Releases Nineteen Specialized Infrared Spectral Data Collections
• Agilent Technologies Introduces New Mass Spectrometer Product Line; Expects to Double Market Share in LC/MS
• TAP Unveils New Automated System for T-flask Cell Culture
• The Department of Chemistry and Chemical Biology at Harvard University Purchase a Site License of ACD/2D NMR Processor
• Grenoble Incorporates ACD/Labs Software into Leading NMR Research Centre
• Protedyne Corporation Appoints Fran Tuttle President and CEO
• GenoLogics Appoints Don Listwin to Board of Directors
• Steve McGarel Joins ABB Switzerland Minerals Business Unit
• Entre Technology Group Announce 2005 Performance Results
• Entre Technology Wins Contract with Fortune 500 Biomedical Company
• Texas Industries (TXI) and Polysius Corporation Select ABB for New Cement Plant Project
• ABB Wins Order for Vietnam Cement Plant Conversion
• Pfizer Selects SYSTECH International to Combat Counterfeiting of Viagra
• Autoscribe Announces New Sample Tracking Software
• Proposed FDA Labeling Rule Could be Challenged by Executive Order
• Initiative on Early Drug Trials Gets Mixed Reviews
• Survey Shows Part 11 Compliance Fuels Regulatory IT Spending
• New FDA Guidances Could Revolutionize Phase I Clinical Trials
• Drugmakers Likely to Foot Bill in Combining EHR and EDC
• Genzyme Selects Labtronics' LimsLink for Global Data Management System
• New White Paper on Best Practices for Managing Laboratory Chemical Inventory
• Autoscribe Introduces Matrix Gemini, a Highly Scaleable, Fully Configurable COTS LIMS
• Thermo Unveils Darwin Commercial-Off-the-Shelf (COTS) LIMS for Pharmaceutical Manufacturing
• Commercial-Off-the-Shelf Solutions Highlight Thermo's Informatics Exhibit at Pittcon 2006
• LabVantage Releases Sapphire R4.4
• STARLIMS Nordic Launched to Serve Sweden, Denmark, Norway, Finland and Iceland
• STARLIMS Congratulates the California Department of Health Services for its "Best of California Award"
• QSI Announces Full Functionality LIMS for Under £400 a Month
• QSI Partnership with Intercol to Emphasize WinLIMS Support
• ABB Supplies Electrical and Process Control Equipment for Holcim’s New Settat Cement Plant
• ClinPhone Named in Top 100 Fastest Growing European Companies
• Teranode and Science Commons to Build Neurology Repository
• Labtronics New LimsLink Release Provides Increased Lab Data Security
• Labtronics Appoints William Bushey to Lead Implementation and Validation Service
• ACD Opens European Office

QSI WinDocs Solution Offers Affordable, Comprehensive Document Control

Documents are the life-blood of business, used to define processes, specify products, record transactions and communicate with customers. Today's quality standards require that documents and records are accessible,
traceable and can withstand scrutiny and audit. Traditional manual methods of document control carry a significant element of risk. Electronic control can provide a secure, convenient solution, and WinDocs is a new package from Quality Systems International (QSI) designed to deliver comprehensive document control at an affordable price. According to QSI's Managing Director Clive Collier " Some available systems cost tens of thousands and are far too complicated, whereas the affordable ones are often little more than filing systems. WinDocs provides all the functionality needed for real document control at a sensible price." Functionality includes full version control, document review procedures, distribution and access control. Documents can be cross-referenced and linked to others. The system offers fast document access with enhanced security protection against unauthorised viewing. The risk of using out-of-date or unauthorised documents is eliminated. WinDocs is built on a secure document repository held within an SQL (Structured Query Language) database, the backbone of most modern database systems. WinDocs is a single- or multi-user application and can be used as a stand-alone package or seamlessly linked to QSI's other quality products like their WinLIMS solution. For details, visit http://www.qsiuk.com.

Informatics Grad Student Named First LabWare Fellow

A student at the Indiana University School of Informatics has been selected as the first recipient of a new fellowship established by LabWare Inc. Swati Lakhanpal, a graduate student at the School’s Indiana University-Purdue University Indianapolis campus, was awarded the LabWare Fellowship in Innovation in Laboratory Informatics. The $30,000 fellowship, awarded annually, aids a student enrolled in the laboratory informatics graduate program and enables the student to further their study and conduct full-time research under the guidance of program faculty. Lakhanpal earned a master’s in chemical engineering at the Florida Institute of Technology and completed her undergraduate work at Panjab University, Chandigarh, India. "Swati Lakhanpal is a perfect choice to be inaugural recipient of the LabWare Fellowship for Innovation in Laboratory Informatics,” says Douglas Perry, Ph.D., associate dean for graduate studies and research and director of the Laboratory Informatics Graduate Program. “She will apply her knowledge and skills as a chemical engineer to extend the practice of laboratory informatics through her thesis research.” T he Laboratory Informatics Graduate Program at IUPUI, the first of its kind in the nation, is designed for students with undergraduate degrees in laboratory-based sciences who seek advanced training in laboratory informatics to pursue careers in the agricultural, biomedical, chemical, food, petroleum and pharmaceutical industries. LabWare is an international software products company focused exclusively on configurable laboratory information management systems (LIMS). Many international companies rely on LabWare LIMS to support their product development and quality assurance functions. Informatics is an evolving field that explains the impact of information technology and develops new uses for it in areas such as health, science, the arts, education, business and industry. The IU School of Informatics was established in 2000 – the first and the largest of its kind in the nation – and has nearly 1,500 undergraduate and graduate students enrolled in programs at campuses in Bloomington, Indianapolis and South Bend. For details, visit http://www.indiana.edu.

Collaboration Agreements Support FDA's Critical Path Priorities List

The FDA is expected to formally release its long-awaited list of priorities for changing the drug development process within the next 30 days, pending agreements between the agency, the NIH and academics, according to a high-ranking FDA official. The agency is finalizing agreements with the NIH and various academic research centers to collaborate on various Critical Path projects before releasing the list, said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs. The FDA is "still in discussions" with these groups, Gottlieb told DID. The need to finalize collaborative agreements and outreach strategies is the "overriding reason" why the list has yet to be released, Gottlieb added. The agency had initially pledged to release a report detailing the initiative's priorities as early as December 2004. Meanwhile, the FDA also has said it will be only the facilitator of the Critical Path Initiative, with the NIH, private companies and academics taking the lead. During a briefing last fall, Nancy Smith, director of the FDA's Office of Training and Communication, said the NIH will have to take a large role in the effort because of funding shortfalls at the FDA. During her presentation at the Regulatory Affairs Professionals Society's 2005 Annual Conference, Smith argued, "while the NIH's budget has doubled" over the last few years, the "FDA's has absolutely not," leaving the Critical Path plan without the necessary funds. As a result, the agency may have to turn to the NIH for help in implementing the initiative, Smith added. The NIH is ready to support the Critical Path Initiative, NIH spokesman Don Ralbovsky said. Critical Path "dovetails nicely" with NIH's own efforts to "more strategically move scientific knowledge into tangible health benefits," Ralbovsky told FDAnews. The two agencies are currently negotiating NIH's role in Critical Path, he added. "The NIH and the FDA have been in constant dialogue about our shared aims and ways to enhance the complementary nature of our respective programs. We expect this process to continue to ensure that the opportunities presented by both the Clinical Path and the NIH Roadmap are fully realized for the benefit of the American people," Ralbovsky said. NIH will be working with the FDA to further Critical Path as part of a similar NIH plan, known as the NIH Roadmap. "Specifically, the NIH Roadmap programs that are relevant to the aims of the Critical Path include those addressing a national informatics infrastructure, coordination of clinical research policies, the training of research and health professionals, bioinformatics, biomarker development, genomics, predictive toxicology, and countermeasures to bioterrorism and emerging infectious disease threats," Ralbovsky said. For details, visit http://www.fda.gov.

Democrats Consider Legislation to Halt Labeling Preemption

The FDA faces growing opposition to its newly released drug-labeling rule as Democrats in both chambers consider legislation to prevent the rule from preempting state law. This move follows a threat by state legislators to sue the agency to overturn the rule. The recently released labeling rule includes a provision that, "FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old, or new format, preempts conflicting or contrary State law." Sen. Edward Kennedy (D-Mass.) and Rep. Maurice Hinchey (D-N.Y.) both challenged this language and pledged to consider legislative options to remove any references to preemption. "It's a typical abuse by the Bush Administration — take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry," Kennedy said. However, the agency argues that preemption has always been the FDA's policy. The agency also believed that restating this position was necessary because of concerns by stakeholders about increased liability under states' "failure to warn" suits. Manufacturer concerns about liability are "the single biggest impediment" to implementing the labeling change, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, told DID. The agency believes the new labeling rule is an "important public health tool," and the FDA wants to ensure it is implemented, Gottlieb added. The FDA also believes it has the scientific expertise to make a final decision on drug labels. State courts do not have the same expertise and should not be able to overrule the agency, Gottlieb said. In addition, the preamble language "will not end litigation," he said, because courts will have discretion to make their own decisions about labeling. While Kennedy was still assessing the regulation, Hinchey suggested that an earlier bill he had introduced, the FDA Improvement Act, could serve to prevent preemption. The bill, H.R. 2090, introduced last May, included language preventing federal standards from preempting state tort law and prohibiting the federal government from intervening in state product liability cases. Hinchey said he would work to advance the bill and that he is exploring other legislative options. A copy of the new rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," is online at http://www.fda.gov/bbs/topics/news/2005/NEW01272.html.

FDA'S New Labeling Rule Aims to Improve Drug Safety

The FDA has issued sweeping changes to its drug labeling rules and has published four guidance documents designed to help drug manufacturers comply with the first major revision to labeling in more than 25 years.
High-ranking agency officials unveiled the draft and final guidances and the final rule on labeling for human prescription drugs and biologic products — designed to reduce medical errors by presenting labeling information in an easier-to-read package insert — at a recent press conference. Under the rule, the FDA will require drug manufacturers to change package inserts to include a highlights section that explains the most important information about a drug, including any health warnings, indication and usage information, and dosage and administration requirements. The agency believes including a summary section will make it easier for doctors to properly prescribe medicines. According to the FDA, roughly 300,000 preventable adverse events occur annually, many of which result from confusing medical information. The labeling initiative already is under fire from various stakeholders who argue the agency is illegally preempting state authority and that the FDA's approach to labeling has not been effective in protecting human health. The agency is facing the prospects of state-led lawsuits and an Institute of Medicine report recommending against its labeling policy, sources say. The FDA will implement the rule in phases, with new applications submitted after the rule's June 30 active date having to comply immediately. Drug products approved within the past five years will gradually be required to revise prescribing information based on how recently the drugs were approved. To access the final rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1269-nfr0001-01.pdf.

ARTEL and Caliper Life Sciences Announce Technology Partnership

ARTEL and Caliper Life Sciences have announced a technology partnership to strengthen quality assurance for automated liquid delivery systems used in the laboratory. As a result of this collaboration, Caliper will now conduct in-house testing on its automated liquid handlers, such as the Sciclone and RapidPlate, using ARTEL’s Multichannel Verification System (MVS). Caliper’s customers benefit from third party verification of equipment performance, as well as the provision of an equipment optimization technology and standard method validation tool that can be integrated into their own laboratories. This partnership leverages ARTEL’s expertise in low volume measurement and Caliper’s innovative automated liquid handling capabilities. For details, visit http://www.artel-usa.com.

Bio-Rad Releases Nineteen Specialized Infrared Spectral Data Collections

Bio-Rad Laboratories, Inc. has announced the release of nineteen high-quality infrared databases including:
Alcohols and Phenols; Aldehydes; Amino Acids and Peptides; Anhydrides and Lactones; Carboxylic Acids; Dyes, Alkynes, and Azo Compounds; Esters; Explosive Materials; HAZMAT; Hydrocarbons and Halogenated Hydrocarbons; Hydrocarbons; Ketones; Nucleic Acids, Nucelosides, and Nucleotides; Organometallics, Inorganics, Silanes, Boranes, and Deuterium Compounds; Phosphorus Compounds; Polymeric Compounds; Steroids; Sugars and Carbohydrates; and, Sulfur Compounds. With the addition of these databases, Bio-Rad now offers over 95 standalone IR spectral databases. Bio-Rad's spectral databases are used by scientists worldwide in the verification, classification, identification of chemical substances across multiple areas of research, such as pharmaceutical, forensic, environmental, materials sciences, and polymers. For details, visit http://www.knowitall.com/newdatabases.

Agilent Technologies Introduces New Mass Spectrometer Product Line; Expects to Double Market Share in LC/MS

Agilent Technologies Inc. has announced introduction of an entire portfolio of chromatography-based mass spectrometry (LC/MS) systems that is expected to nearly double its LC/MS market share by 2008. The new Agilent 6000 Series LC/MS portfolio is expected to set a new standard in price-performance, reliability and ease-of-use that the company says will transform productivity in the laboratory. The Agilent 6000 Series will include five classes of instruments, including the company’s first triple quadrupole (triple quad) and quadrupole time-of-flight (Q-TOF) mass spectrometers. With these additional instruments, Agilent now will be able to address nearly 70 percent of the estimated $1.3 billion LC/MS instrument market – more than double its current market opportunity. The 6000 Series also includes Agilent’s single quadrupole, ion trap and time-of-flight (TOF) mass spectrometers. Each of the new LC/MS instruments includes the following three features that are unique to Agilent: Agilent’s proprietary autotune technology that automatically calibrates the instrument with the click of the mouse, optimizing for sensitivity and mass accuracy; Compatibility with Agilent’s multimode source and HPLC-Chip technology; and, Integration with LC and MS software for instrument control and data analysis. For details, visit http://www.agilent.com/chem.

TAP Unveils New Automated System for T-flask Cell Culture

The Automation Partnership (TAP), a world leading manufacturer of innovative automation for life science applications, has unveiled its new automated cell culture system CompacT SelecT, which has been designed for managing the process of preparing, culturing and harvesting cells in T-flasks and delivering them into assay-ready plates. CompacT SelecT, which is slightly larger than a Class II safety cabinet, has been innovatively engineered as a smaller and more affordable version of TAP’s internationally proven SelecT automated cell culture system, making this outstanding technology available to more pharmaceutical / biotech companies and academic institutions. CompacT SelecT can increase productivity by continuous unattended operation to simultaneously culture multiple different cell lines and automatically manipulate T-175 flasks using its unique anthropomorphic arm. Cells produced can either be harvested or automatically plated into 96 and 384 well plates and will also detail how the sterility of the cell culture environment is preserved and a complete audit trail assured. For details, visit
http://www.automationpartnership.com/tap/news/pages/curr_news.asp.

The Department of Chemistry and Chemical Biology at Harvard University Purchase a Site License of ACD/2D NMR Processor

Advanced Chemistry Development, Inc. (ACD/Labs) has announced that the department of Chemistry and Chemical Biology at Harvard University has chosen ACD/2D NMR Processor as their NMR processing package of choice. ACD/2D NMR Processor will be deployed to all staff, students, and faculty to use on both PCs owned or leased by the department as well as on individual user’s personal machines. The key person involved in seeing this project to fruition at Harvard’s Dept. of Chemistry and Chemical Biology was head librarian of the Chemistry and Chemical Biology Library, Ms. Marcia Chapin. Marcia had the daunting task of taking a long list of requested capabilities and features and finding a suitable NMR application to meet her patrons’ needs. Some of the requested capabilities involved automatic generation of multiplet reports set to a specific journal format, and software stability. During the software evaluation, ACD/2D NMR Processor was able to meet and exceed everyone’s expectations for a complete and easy-to-use processing package in a very competitive head to head comparison with other NMR processing utilities. For details, visit http://www.acdlabs.com.

Grenoble Incorporates ACD/Labs Software into Leading NMR Research Centre

Advanced Chemistry Development, Inc., (ACD/Labs) has announced that the Université Joseph Fourier (UJF), a major player in the science and technology field in the Grenoble area, France, has installed a complete suite of ACD/Labs’ NMR prediction, verification, and data management software tools at their Centre Grenoblois de Résonance Magnétique (CGRM). The installation encompasses ACD/Labs’ 1H and 13C NMR Predictors for calculating chemical shifts and coupling constants; 1D and 2D NMR Processors for vendor-neutral processing and analysis; and the NMR database modules of ACD/SpecManager, the overall spectroscopic processing and data management software that unifies analytical data information of all types into a single interface. Researches at the CGRM evaluated several commercially-available software packages, and determined that ACD/Labs’ NMR software met and exceeded their spectral assignment needs. By providing them with a means of capturing legacy data, they will be able to reduce the amount of data lost when doctorates leave and information isn’t transferred properly. This system will serve as a rich resource for both present and future UJF researchers, as they gain the ability to easily search and retrieve legacy data, therefore reducing analysis rework.For details, visit http://www.acdlabs.com.

Protedyne Corporation Appoints Fran Tuttle President and CEO

Protedyne Corporation, a leading laboratory automation provider, has announced that Fran Tuttle has joined the company as President and Chief Executive Officer and will also join the company’s Board of Directors. Protedyne also announced that Rolf Classon has been elected Chairman of the Board. Classon has served on Protedyne’s Board of Directors since August 2004. Ms. Tuttle has over 25 years of experience in life sciences leadership. Most recently, she was Senior Vice President of Near Patient Testing at Bayer Diagnostics, one of the world’s largest diagnostic companies. At Bayer, she was responsible for a worldwide business of $400 million. Before joining Bayer Diagnostics, she spent 20 years at Chiron Diagnostics (formerly Ciba Corning Diagnostics), a leader in molecular and immunodiagnostics. Ms. Tuttle began her career as a CPA at Peat, Marwick, Mitchell and Company (now KPMG). She also holds an MBA from Harvard Business School. For details, visit http://www.protedyne.com.

GenoLogics Appoints Don Listwin to Board of Directors

GenoLogics Life Sciences Software Inc., a leading provider of an integrating platform and data management systems for systems biology research, has announced the appointment of Don Listwin to the company’s board of directors. Listwin is a networking industry veteran who spent a decade at Cisco Systems as Executive VP, having left the company in 2000. Most recently, Listwin served as the former President and CEO of Openwave Systems, a software and services provider for the communications industry. In 2004, based on personal experience with family members fighting cancer, Listwin founded Canary Foundation, the only non-profit organization in the United States entirely dedicated to the early detection of cancer. Today the Canary Foundation is investing in research to catalyze the development of a biomarker discovery platform for early detection of cancer. Listwin is chair of the boards of Canary Foundation and Sana Security. He has previously served on the boards of Openwave, JDS Uniphase, Redback Networks, TIBCO Software, E-Tek, the Cellular Telecommunications & Internet Association (CTIA) and NetAid. Listwin is a member of the Board of Trustees at the Fred Hutchinson Cancer Research Center in Seattle Washington . A native of Canada , Listwin holds a B.S. in electrical engineering and an honorary doctorate of law from the University of Saskatchewan. For details, visit http://www.genologics.com.

Steve McGarel Joins ABB Switzerland Minerals Business Unit

ABB, a global power and technology group, has appointed a new Regional Sales Manager responsible for North and Central America; the UK and Ireland; Australia and New Zealand; India and Pakistan and Southern Africa.
Steve McGarel will be a member of the Minerals Processing Automation team headed by Rauli Hantikainen and will be based in Baden, Switzerland. Steve joins ABB from Pavilion Technologies and brings to the team more than 20 years of experience in metallurgical, fertilizer and cement plants in both process and management roles. Amongst this he has over 6 years experience in sales and implementation of cement process optimization solutions, contributing to direct sales; product functional design; project implementation; internal consulting and field engineering support on an international basis. Prior to this he spent 11 years in operations management on cement plants in South Africa and played an important role in the design and implementation of the first model based control applications on cement kilns and mills in 1999. As the author of multiple published papers and co-inventor of several patents on cement process optimization, Steve has had considerable influence on the competitive landscape for cement process optimization and we are proud that Steve has chosen to join the ABB team For details, visit http://www.abb.com/minerals.

Entre Technology Group Announce 2005 Performance Results

Entré Technology Group, a leading provider of OEM technology and embedded computing solutions, reported a 26% increase in revenue and the highest gross margin in Company history for the fiscal year ended December 31, 2005. Because the Company is privately held, specific amounts were not disclosed. Total revenues for the year ended December 31, 2005 increased 26% over fiscal year 2004 driven largely by the award of two OEM PC and Printer fulfillment contracts with a combined valued of over $1,000,000. The services division, CyberTechs, also helped drive growth with a first quarter technology-refresh project valued at just over $189,000 and the addition of an OEM PC fulfillment client with purchases of $412,000 during the year. “The exciting thing about the success we had in 2005 is that it has laid the foundation for continued success in 2006,” said Bob Clayton, President of Entré. “Our clients in the OEM and embedded space are large medical diagnostic companies and laboratories that are relying on us to fulfill more and more of their embedded technology needs. We consistently compete against, and beat, the billion dollar integrators that cannot provide the responsiveness and account servicing that we can. Additionally, due to our strong financial performance, our clients know we have the resources required to keep their production lines supplied with embedded PCs and printer solutions. In our estimation we supply OEM and embedded products that help our clients generate an aggregate of nearly $4 billion in annual revenue.” Entré Technology Group is a privately held company with two operating divisions. The Entré division provides OEM and embedded solutions to medical diagnostics companies and medical laboratories throughout North America. The Cyber-Techs division provides network IT services to companies based in the Dallas/Fort Worth metroplex. Each division is operated independently and each division reported revenue and gross margin increases for fiscal year ended December 31, 2005. For details, visit http://www.entretechnology.com.

Entre Technology Wins Contract with Fortune 500 Biomedical Company

Entré Technology Group, a leading provider of OEM technology and embedded computing solutions, was awarded a nationwide PC fulfillment project by a global, multibilliondollar, broad-based health care company. The contract covers PC equipment used to remotely monitor, manage and service several lines of medical diagnostic instruments such as immunoassay systems and hematology analyzers. Entré will be relied upon to ship pre-configured PCs that are customized for each installation direct to the end-user location. “We are very pleased to be awarded this contract. It demonstrates the confidence our clients have in our ability to act as an extension of their organization to serve their customers and markets.” said Bob Clayton, President of Entré. “With this particular client we have maintained a 99.9% on-time and 99.9% quality rating on tens of thousands of units shipped since we became a certified supplier in 1990.” The contract calls for Entré to configure a Windows-based PC with site specific settings and ship it directly to the end-user location for installation by a Field Service Engineer. The PC operates in a “headless” configuration, which means it does not have a keyboard, mouse or monitor. The first article has already been approved and shipments are expected to begin by the end of January. Total unit volume and dollar value of the contract were not disclosed. Entré Technology Group provides OEM and embedded technology solutions to medical companies and labs throughout the United States, Puerto Rico, and Canada. For details, visit http://www.entretechnology.com.

Texas Industries (TXI) and Polysius Corporation Select ABB for New Cement Plant Project

ABB, a leading power and automation technology group, has announced that it has been awarded a contract by TXI, the largest producer of cement in Texas and a major producer in California, for part of a complete new cement plant near Riverside, California. Project partners are Polysius Corporation, Zachary Construction and AMEC Engineering. The Riverside Cement Plant is located at Oro Grande, in the Mojave Desert of southern California. The contract, which includes an order value of over 4 Million Dollars, was awarded to ABB in November 2005. Start-up of the plant is scheduled for the fourth quarter of 2007. The scope of supply includes all motors, drive systems, gas analyzers & Continuous Emission Monitoring System (CEMS) for the new raw mill, pyre-processing line and finish mill processes. Polysius, a specialist in equipment for the cement industry, required complete compliance to meet their equipment specifications. This involved special designs for motors, complete system and US Environmental Protection Agency (EPA) compliance responsibility for CEMS as well as integration services for gas analyzers, E-houses and CEMS. The Riverside project is the first new cement plant to begin construction in the US within the last five years. At the same time, it is the largest of ABB’s major recent orders for this industry and with Polysius USA. There are many new projects of this type planned for 2006 and 2007 and ABB, with this project award, proves to be a capable and competitive supplier for the cement industry. The new Riverside plant will establish TXI as a low cost producer for this region. TXI will increase the production and reliability of cement in a strong market. For details, visit http://www.abb.com/cement.

ABB Wins Order for Vietnam Cement Plant Conversion

ABB, a leading power and automation technology group, has announced that it has entered into a contract with Hatien II Cement Company, an affiliate of Vietnam National Cement Corporation (VNCC), for their conversion project from fuel oil to coal burning. ABB has been supplying several products and systems to the same customer since 1997. The contract became effective in September 2005 while production start is planned for the end of 2007. The plant is located at Kien Luong, in the Kien Giang province of Vietnam. ABB’s deliveries comprise the complete electrical and automation system with MV switchgear, LV distribution and power factor correction, transformers, electrical cables, Industrial IT control system, as well as design and technical documentation & technical services. For details, visit http://www.abb.com/cement.

Pfizer Selects SYSTECH International to Combat Counterfeiting of Viagra

SYSTECH International, a leading provider of Packaging Performance Management solutions for manufacturing operations, has announced the successful deployment of its TIPS Serialized Product Tracking software on Pfizer's Viagra packaging line. The solution manages all packaging line devices, including writing and recording EPCs to the RFID tags and redundant bar codes. The software enables Pfizer to verify all data on the RFID tag and bar code, establish parent-child relationships in which the products are placed, store events and information in a secure database, and share the information with partners in the distribution chain for authentication of the Viagra product. The solution also handles all real-time packaging level business processes including managing rejects, reworks, and QA functions. TIPS Serialized Product Tracking is part of SYSTECH's comprehensive suite of machine vision inspection, packaging line automation and information management solutions. For details, visit http://www.systech-tips.com.

Autoscribe Announces New Sample Tracking Software

Autoscribe's new Sample Tracker allows users to track samples and the progress of work and is suitable for many applications in a wide variety of industries. Sample Tracker may be used in both highly regulated and unregulated industries and provides exactly the same user experience no matter how the application is accessed; rich client on a LAN, thin client on a WAN, or via the Web using a standard browser. The unique OneTime Configuration tools automatically create a unified Sample Tracking configuration for both desktop and web use. Once a screen has been built using the unique OneTime Configuration Tools, it is immediately available on the user's network or via the Web. Sample Tracker benefits include: Simplified sample management by tracking work and samples; Enhanced traceability and accountability by auditing all actions; Saves time by automatically allocating tasks / tests to samples as they are registered; Eliminates errors by allocating a unique identifier to each sample; Immediate feedback on work progress using the status features; Enhances available information through a standard set of reports e.g. trend of sample turnaround times; Allows full protection of entered data; Supports barcoding (requires barcode hardware). Sample Tracker is built on Autoscribe's Matrix Gemini technology and is developed using pure Microsoft .NET tools. For details, visit http://www.autoscribe.co.uk.

Proposed FDA Labeling Rule Could be Challenged by Executive Order

State lawmakers are considering a legal challenge to a proposed FDA rule, which they argue improperly limits state authority to require more stringent labeling requirements. The National Conference of State Legislatures (NCSL) argues that the agency's alleged plan to preempt state authority over drug labeling is in direct violation of Executive Order (E.O.) 13132 on Federalism. The group may use the order to sue the FDA to force another round of public comments before the agency could issue its final rule, said NCSL staffer Joy Wilson. The states group contends the FDA's proposed labeling rule would essentially limit industry liability under state product liability laws by allowing a federal labeling standard to take precedence. States would be unable to bring "failure to warn" claims under state common law if the federal rule preempts state standards, said NCSL staffer Susan Frederick. The NCSL believes that federal rules are meant to be the very minimum of protectiveness and that state law is supposed to represent the most protective standard. E.O. 13132 requires that the federal government first consult with state and local governments before finalizing rules that present a potential conflict between state and federal law. But the agency supposedly will soon issue a final labeling rule that will preempt state laws without providing state and local governments the ability to comment, noted Frederick and Wilson. According to a recent NCSL letter to HHS Secretary Mike Leavitt, the agency's decision to issue the final rule represents "a thinly-veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial rulings." The Food, Drug & Cosmetics Act does not give the agency authority to preempt state law in the area of prescription drugs, the letter states. The group added that the agency's decision not to go through another round of public comments "amounts to an abuse of agency process and a complete disregard for our dual system of government." FDA officials could not be reached for comment. PhRMA declined to comment until the final rule is issued, an association spokeswoman said.For details, visit http://www.fda.gov.

Initiative on Early Drug Trials Gets Mixed Reviews

The FDA's latest bid to accelerate new drug approvals, while praised by the pharmaceutical industry, is facing a backlash from some lawmakers and advocacy groups who point to the proposal as evidence the agency is too close to industry and does not place enough emphasis on public health. In a series of guidance documents released last week, the FDA said it aims to bring more efficiency to the earliest stages of clinical drug development. Under the guidance, clinical investigators can begin to test microdoses of investigational drugs in small numbers of people before they would normally start conventional Phase I clinical trials. The idea is to weed out unpromising compounds early in the development process. Senate Finance Committee Chairman Chuck Grassley (R-Iowa), a frequent critic of the agency, argued the FDA is loosening the reins on drug companies. "It's no secret that the FDA is too cozy with the drug industry, so I'm concerned for those who will be receiving these experimental drugs," said Grassley, who pledged to keep a close eye on the new guidance documents. "I'll work to ensure that these regulations don't compromise human safety," he said. Sidney Wolfe, director of Public Citizen's Health Research Group, agreed the guidance documents are a concern. These efforts are "reducing the protections to human subjects," Wolfe said. Human subjects will be at greater risk because the new approaches would reduce the number of animal tests undertaken before humans receive the drugs, he said. For details, visit http://www.fda.gov.

Survey Shows Part 11 Compliance Fuels Regulatory IT Spending

Life sciences industry spending on IT is rising rapidly and poised to accelerate more than 15 percent each year through 2011, in part due to Part 11 compliance and legacy system remediation projects, says a survey from Frost & Sullivan. "The life sciences industry is now in a period of transition, as it seeks to use IT in resolving the process inefficiencies that cause a lot of dollars to be wasted across the spectrum, from R&D to post-marketing," said Raghavendra Chitta, an industry analyst with Frost & Sullivan. "These companies are now witnessing a sharp uptake of IT tools, which is not limited to the drug discovery process in the life sciences industry." Regulatory requirements are now one of the main drivers of IT spending in the life sciences industry, the survey said. The recent drug withdrawals have brought about an increased focus on pharmacovigilance and related regulatory compliance. There have also been huge investments to achieve Part 11 and other related compliance.
While big pharma companies hold potential for IT vendors because of their more mature, predictable and large IT budgets, they are also more complex customers, the survey says. The recent drug recalls and pricing pressures have triggered rationalization of operational costs. The larger pharmaceutical companies have already replaced legacy systems or are replacing them, thus leaving little chance for increased IT spending. For details, visit http://www.fda.gov.

New FDA Guidances Could Revolutionize Phase I Clinical Trials

Clinical investigators can begin to test microdoses of new investigational drugs in smaller numbers of people before beginning conventional Phase I clinical trials, according to new FDA guidances that could change the face of clinical trials. The agency's goal is to improve the process for bringing drugs to market by knowing more about a drug's properties and effects before beginning Phase I trials, officials announced at a recent press conference. In effect, a "Phase 0" smaller trial will be included following animal studies in many trials before beginning conventional Phase I trials. The initiative is part of the agency's March 2004 Critical Path Initiative that outlined challenges that plague the drug development process, which is "long and complex, expensive and too often uses technology of the last century," acting FDA Commissioner Andrew von Eschenbach told the press briefing. He said that nine out of 10 compounds developed in the lab fail in human studies largely because they behave differently in people than in animals and laboratory tests. These new changes to exploratory studies will "remove hurdles in earliest phases so researchers can more rapidly establish whether a compound has clinical benefit for patients," Eschenbach said. To explain the changes to industry, the FDA issued guidance on exploratory investigational new drugs (INDs) — a new type of IND for clinical studies that offers "advice on conducting very early studies for drugs and biotherapeutics," Janet Woodcock, deputy commissioner for operations told the press. Unlike Phase I studies, which aim to test dosage levels in large numbers of people, this allows early testing with microdoses in people before traditional Phase I trials commence. Microdose studies use extremely low doses, well below what would normally be dispensed in a Phase I trial, Woodcock said. In fact, the dose is so low that a research participant would not feel any effect, nor would any effect be outwardly observed, she said. However, with modern imaging technology, microdoses will reveal how a compound distributes and metabolizes and whether it hits its target organs, she explained. This technology reveals a "tremendous amount of information in exploratory studies without exposing patients to risk," she said. For details, visit http://www.fda.gov.

Drugmakers Likely to Foot Bill in Combining EHR and EDC

Pharmaceutical companies will likely have to be the main investors in merging the parallel universes of electronic health information on the healthcare side and electronic data capture on the clinical research side to achieve interoperability, according to experts. The merging of electronic health records (EHR) and electronic data capture (EDC) will increase patient safety and reduce many of the costs associated with clinical trials, but all stakeholders will need to participate in the dialogue and pick up some of the tab to make it a reality, agreed presenters at a recent ExL Pharma conference in Reston, Va. "There is money to be invested," said Somesh Nigam, information management director for Johnson & Johnson, who explained that merging EDC and EHR will lead to more research opportunities because protocols can be better matched to patients by electronically weeding through exclusivity and inclusivity data, resulting in increased patient enrollment. The merge should also result in reduced monitoring visits, which could greatly benefit sponsors, Nigam said. "I think drugmakers will be willing to pay but it just needs to be packaged in the right way," he said. Pharmaceutical companies will also reap the benefits of being able to access data in real time, which will enhance patient safety and streamline many of the administrative processes associated with clinical trials. So why isn't industry clamoring to bring the technologies together? "This is just the beginning," said Hugh Donovan, general manager for Siemens Medical. He expressed his frustration with the overwhelming perception that merging EHR and EDC was some sort of impossible task. "There are lots of issues ... but we have to get out there and do it and see what happens in reality," Donovan said. "The real benefit is to be able to pull the data." "First we have to make sure we can communicate and document how the pieces fit together," said CDISC President Rebecca Kush. "There are a lot of questions and the pilot with FDA is a work in progress that will become the standard, not just one of many." The FDA's Critical Path Initiative, which aims to get more products into the pipeline to keep pace with technological advancements, fits nicely into CDISC's goal of developing a standard model that supports the entire life-cycle of clinical research protocols to achieve semantic interoperability, Kush explained. HL7 fits in by providing standards for exchanging, managing and integrating data that support both EHR and EDC. For details, visit http://www.fda.gov.

Genzyme Selects Labtronics' LimsLink for Global Data Management System

Labtronics Inc. has announced that Genzyme Corporation has chosen Labtronics’ industry-leading LimsLink solution to provide the integration capabilities required to achieve their goal of creating a Global Product Data Management solution. Genzyme is one of the World's top biotechnology companies, and its rapid growth has resulted in many regulated products both in the marketplace and in their pipeline. This has created an increase in the amount of product data that they need to capture, process and archive by several orders of magnitude over the
past few years. Genzyme recognized that they needed to ensure that these large volumes of product data could be managed effectively and efficiently while also complying with the many regulations inherent in their industry.
Genzyme determined that they needed to create a Global Product Data Management system that consists of many laboratory systems working together as a cohesive solution. They implemented a new LIMS snd Scientific Data Management System (SDMS) to deal with the massive amounts of data being generated by their laboratory instruments, recognizing the need that these instruments and systems communicate in order to leverage their technology investment. Genzyme chose Labtronics’ LimsLink laboratory data integration solution to provide
the required communication capabilities. LimsLink can provide a bi-directional connection between all of the company’s laboratory instruments and their management systems, both LIMS and SDMS. The automation of test results downloaded from their lab instruments to their management systems enables Genzyme to eliminate
human error in data entry and to increase lab productivity. LimsLink is also fully compliant with the regulations that biotechnology companies have to comply with including FDA 21 CFR Part 11. For details, visit http://www.labtronics.com.

New White Paper on Best Practices for Managing Laboratory Chemical Inventory

ChemSW, Inc.’s latest white paper details best practices in chemical inventory management, providing insights to ensure system adoption and successful incorporation into lab processes. Reasons why systems fail and why they succeed are examined, as well as the true costs associated with chemical inventory management and cost savings that result when such a system is optimized for maximum effectiveness. For your copy, visit http://www.ChemSW.com/bestpracticepr.htm.

Autoscribe Introduces Matrix Gemini, a Highly Scaleable, Fully Configurable COTS LIMS

Autoscribe has introduced Matrix Gemini, a LIMS that provides exactly the same user experience no matter how the application is accessed; whether it is via a rich client on the LAN, a thin client on the WAN, or via the Web using a standard browser. Unique OneTime Configuration tools automatically create a unified LIMS configuration for both desktop and web use. Once a screen has been built using the OneTime Configuration Tools, it is immediately available on the network or via the Web. Unlike most current commercial LIMS, the web interface is not a “bolt on” to an old application. This new technology allows companies to deploy exactly the same interface to all users, reducing deployment, training, validation and maintenance costs. Autoscribe’s Matrix Gemini LIMS also provides all existing customers with the opportunity to seamlessly migrate their current desktop applications to the web without the requirement to use programming, java or esoteric scripting languages. When existing Matrix V4 users upgrade to Matrix Gemini, supplied under their support agreement, they will have immediate access to all their existing client screens via their web browsers, with no additional work or costs. A concurrent user licensing scheme allows customers to mix and match network and web connections as they need them, changing from day to day as required – again no extra fees to pay. Matrix Gemini is developed using pure Microsoft .NET tools. For details, visit http://www.autoscribe.co.uk.

Thermo Unveils Darwin Commercial-Off-the-Shelf (COTS) LIMS for Pharmaceutical Manufacturing

Thermo Electron Corporation, a world leader in analytical instruments and informatics, has announced the
commercial availability of Darwin LIMS, the latest evolution in commercial-off-the-shelf (COTS) laboratory information management systems for pharmaceutical manufacturing R&D and QA/QC. A natural selection for the world's leading pharmaceutical companies, Darwin has been developed to lower the cost, risk and time associated with implementations as well as the total cost of ownership (TCO) of modern LIMS solutions. "Thermo is responding to customer demands for software solutions that address the specific needs of their laboratories without extensive customization," said Dave Champagne, vice president and general manager of Thermo's informatics business. "This is especially important to our pharmaceutical customers because of that industry's complex testing, workflows and regulatory requirements. They need solutions that are easy and rapid to deploy and adopt, easily upgraded and seamlessly integrated into their organizations." Darwin fulfills many customer requirements "out-of-the-box" by providing deeper, more targeted pharmaceutical functionality compared to traditional LIMS. Users will find dissolution, content uniformity, stability management, product management, batch management and system interfacing as dedicated capabilities within Darwin - fully supported by Thermo's helpdesk and covered in depth in the user manual. The inclusion of such functionality as standard in the base system significantly reduces on-site customization, resulting in reduced costs, risks and time associated with implementation, training, validation, maintenance and upgrades. In addition, Darwin is not limited to a restrictive sample-centric workflow. Darwin's product- and batch-oriented workflows allow R&D and production data to be logically organized, summarized and reported, allowing users to work more effectively and providing managers with a broad view of the entire manufacturing process. Darwin has been created using the Microsoft .NET framework. This enables users to extend the system using industry standard tools, not a proprietary language that the vendor must teach key users of the system how to program. For details, visit http://www.thermo.com/lims.

Commercial-Off-the-Shelf Solutions Highlight Thermo's Informatics Exhibit at Pittcon 2006

Thermo Electron Corporation, a leading provider of analytical instrumentation and informatics, will showcase its purpose-built, commercial-off-the-shelf (COTS) LIMS and CDS solutions at Booth # 3733 at Pittcon 2006, March 13-16 at the Orange County Convention Center in Orlando, Florida. "Visitors to Thermo's booth will find tailored informatics solutions, designed to meet specific industry and application requirements with the minimum amount of customization," said Dave Champagne, vice president and general manager of Thermo's informatics business. "Our value proposition is the reduction in cost, risk and time of implementations, as well as total cost of ownership, that are associated with extensive customization. Plus, the greatly enhanced integration between our solutions and the customers' enterprise yields increased efficiency and greater knowledge from data." Thermo's informatics exhibit will feature: 1) Darwin LIMS the laboratory information management system designed specifically for pharmaceutical manufacturing R& and QA/QC; 2) The latest version of SampleManager LIMS, 9.0, which begins its evolution as a COTS solution for industrial laboratories; 3) Atlas CDS 8.0, Thermo's renewed chromatography data system with superior integration with SampleManager and Darwin for maximum productivity; 4) Migration Agent, a new software and professional services solution that reduces risk and overcomes business challenges when migrating from any existing LIMS to a Thermo LIMS; 5) Retriever, a web-based data extraction, presentation and reporting solution that enables secure access to laboratory data, no matter the originating data system. Thermo has had five informatics oral and poster presentations accepted by the Pittcon committee as part of the conference program. Topics include "Using LIMS to Drive Productivity in the Manufacturing Environment" and "LIMS Implementation Trends in Discovery Research." A full schedule is provided on www.thermo.com/pittcon, see Technical Presentations. In addition to its informatics solutions, Thermo will be exhibiting a wide range of industry leading instrumentation, software and services.

LabVantage Releases Sapphire R4.4

LabVantage Solutions, Inc., a leading provider of thin-client LIMS, has announced the availability of its new release Sapphire R4.4. Sapphire R4.4 offers a significant number of new features and benefits including: Architectural Enhancements; Enhanced Scheduling; M18N Internationalization Improvements; Advanced Analytical Quality Control Functionality; Programmable Business Rules; New Archiver Module; Improved Patching Capabilities; Clustering Module; Evergreen Configuration Tool Enhancements; Enhanced Stability & Shelf-Life Testing Module; LDAP Capabilities; and, BioBanking Module. "Sapphire R4.4 further adds to the out-of-the-box functionality available in Sapphire to better address the needs of the top research, development, formulation, raw material testing, and quality management laboratories,” said Jim Aurelio, CEO of LabVantage. “As a true thin-client solution [versus just a web-enabled software], Sapphire is unlike any other leading LIMS on the market, enabling enterprise-wide access and visibility coupled with the lowest total cost of ownership for our customers,” he added. Sapphire R4.4 is available immediately. As an added benefit to current maintenance & support customers, LabVantage also announced that it will perform free virtual installations and upgrades of Sapphire on any licensed server. As with previous versions of Sapphire, this release features a user-friendly interface enabling quick end user acceptance and training. Sapphire’s built-in Evergreen configuration tool allows Sapphire to readily adapt to a variety of data capture, result management, storage, and sample handling needs for any laboratory – whether it’s for an initial deployment or to address future changing business requirements. With functionality spanning from R&D through manufacturing, all on one enterprise platform, Sapphire offers IT organizations the ability to support only one complete solution, rather than multiple point systems. Moreover, Sapphire’s open architecture and API enable easy integration with third party systems, instruments, databases, and other business applications. For details, visit http://www.labvantage.com.

STARLIMS Nordic Launched to Serve Sweden, Denmark, Norway, Finland and Iceland

STARLIMS Corporation, a global provider of LIMS, has announced the opening of a new office in Stockholm. STARLIMS Nordic will serve existing and new customers in Sweden, Denmark, Norway, Finland and Iceland. "The establishment of this new office is an outgrowth of STARLIMS's expanding activities in the Nordic region," said Rene Pronk, Managing Director of STARLIMS Nordic. "It also reflects the company's European growth strategy, which includes providing immediate on-site support in all areas of the continent. The new STARLIMS Nordic organization gives us important new opportunities, since customers in the region naturally prefer to deal with local representatives. We are delighted to establish this new team, which is fluent in Swedish and Finnish as well as English." STARLIMS Corporation has been active in Nordic countries for several years, and has signed several contracts with customers in the region.For details, visit http://www.starlims.com.

STARLIMS Congratulates the California Department of Health Services for its "Best of California Award"

STARLIMS Corporation, a leading global provider of LIMS, has announced its congratulations to the California Department of Health Services (CDHS) for receiving the "Demonstrated Excellence in Project Delivery - Best of California Award". CDHS received the award in recognition of its implementation of a STARLIMS solution in the Richmond Laboratory Complex, the tertiary public health lab for the State of California. "We are delighted to see CDHS receiving this much-deserved recognition," said Jeff Ferguson, Chief Operating Officer at STARLIMS Corporation. "The success of this project reflects the commitment and hard work of key CDHS managers, and the leadership of Mr. Chris Cruz, Senior Project Manager. We congratulate Mr. Cruz and CDHS on their achievements and look forward to continued collaboration." Best of California Awards are designed to recognize California government agencies for "efforts and innovations to advance service to the citizen via the use of technology. They are awarded by the Center for Digital Government, a national research and advisory institute on information iechnology policies and best practices in state and local government. The new STARLIMS solution integrates all RLC laboratory activities into a single platform-which interacts with the State's CAHAN, ELR and WebCMR initiatives to provide easily accessible data for informed decision-making. Replacing several legacy systems, it incorporates input from over 110 instruments and a workflow for approximately 200 tests. The STARLIMS solution serves about 100 lab technicians and scientists in five laboratories. For details, visit http://www.starlims.com.

QSI Announces Full Functionality LIMS for Under £400 a Month

Quality Systems International (QSI) has announced that they are now offering a subscription payment option that will enable establishments with limited budgets to enjoy the benefits of LIMS for under £400 a month. This monthly fee covers software licences, installation, training, technical support and any software enhancements for the term of the contract, and at the end of the term the system is fully owned. Although particularly attractive to those with limited budgets, the new scheme will have many attractions for larger users - less impact on cash flows and the capital budget, low entry costs and guaranteed upgrades. This financial solution preserves existing lines of credit, and the subscriptions are fully tax-deductible. Going down the subscription route in no way compromises the performance of the system, indeed the WinLIMS "out of the box" package is very comprehensive, offering functionality such as Document Control and Health and Safety procedures. Also included is a secure online reporting module powered by Business Objects Enterprise II and Crystal II, technology licensed at an attractive price through an OEM agreement exclusive to WinLIMS. For details, visit http://www.qsi.co.uk.

QSI Partnership with Intercol to Emphasize WinLIMS Support

Quality Systems International, a global LIMS vendor, has announced a strategic business partnership with International Agencies Co. Ltd. (Intercol), a leading Bahrain based Private Limited Company who have been
supplying and supporting IT solutions throughout the Gulf Region for over 10 years. QSI’s WinLIMS is available as an “Out of the Box” product, yet has built-in functionality for the food and drink sector, including formulations and recipe management, materials requirement planning (MRP), full batch traceability, shelf life stability trials, vendor assurance, and more. QSI’s alliance with Intercol is a new step in their commitment to service and support for clients across the globe. Intercol’s Information Technology Group are responsible for sales, implementation, and support of WinLIMS throughout the region. These services are provided from two technology centres located in Dubai and Bahrain. Each centre is staffed by a team of highly trained IT professionals who will ensure that all users of WinLIMS will maximise the benefits of implementing WinLIMS within their organisations. For details, visit http://www.qsi.co.uk.

ABB Supplies Electrical and Process Control Equipment for Holcim’s New Settat Cement Plant

ABB, a leading power and automation technology group, has been awarded a contract from Holcim (Maroc) S.A. In 2004 Holcim decided to build the packing plant at the Settat location, about 70 kilometres south of Casablanca, Morocco. At the end of 2004 Holcim decided to establish a complete cement factory by expanding, in two steps, with a new cement grinding plant and a clinker production line. The grinding plant will have a capacity of 1.7 Mio tons per year, while the clinker production capacity will be 4000 tons a day. Operation of the grinding plant is scheduled for the third quarter of 2006, respective for the last months in 2007 for the clinker production line. The quarry is located about 25 km from the main plant and the limestone will be transported using a railway between the two locations. ABB engineered, supplied, installed and commissioned the complete electrical equipment for the packing plant, including high voltage distribution, main transformers and medium voltage distribution. The packing plant went into operation after a demanding short construction period on schedule. The cement is produced in the other Moroccan Holcim plants in Fès and Oujda and delivered by railway to Settat. To cope with the production of the new plant, the expansion of the packing plant with two additional silos, an additional packing line and a palletizer has been under construction since the middle of 2005. For cement grinding and clinker production ABB delivers the high and medium voltage distribution, transformers, the low voltage motor control centers, the medium and low voltage motors and drives as also the process control system. The process control system will finally be combined into one system at the main plant and another at the remote quarry, using the same design and application principles for convenience of use and maintenance. For details, visit http://www.abb.com.

ClinPhone Named in Top 100 Fastest Growing European Companies

ClinPhone, a global leader in clinical technology solutions, has been named as one of the fastest growing companies in Europe. Business Week and Brussels-based Europe's 500 Entrepreneurs for Growth teamed up for the second consecutive year to showcase the top 100 fastest growing European companies. ClinPhone was named at number 71 in the list, registering a staggering 218% increase in sales since 2001. This is the latest in a long line of awards received by ClinPhone, again recognizing the company's continued growth and exemplary operation. To be ranked on Europe's top 100 list a company must have been founded before 2002, have had at least 50 employees at the beginning of 2001 and have shown profits on at least one occasion during a three year reference period. As many of Europe's blue chip businesses are shedding thousands of workers, this list recognizes small and mid-sized companies who are increasing their employee base and posting healthy sales growth. ClinPhone was founded in 1993 as a technology company whose aim was to improve the clinical trial process by providing centralized support services that are available 24/7. The original concept developed into a global business that now provides a range of eClinical solutions to many of the world's leading pharmaceutical and biotechnology companies. Today, ClinPhone's range of services are driven by a unique integration of Internet and telephone based technologies enabling process improvement for sponsors as well as CRO partners. Building on its telephone and web-based randomization and medication management expertise, ClinPhone can offer a wide range of innovative products covering all aspects of a clinical trial, including Electronic Patient Reported Outcomes (ePRO), Interactive Voice and Web Response (IVR and IWR), Patient Recruitment Solutions and Clinical Trial Management Software (CTMS). For details, visit http://www.clinphone.com.

Teranode and Science Commons to Build Neurology Repository

Teranode, an innovator of experiment design automation software for the Life Sciences industry, has announced that it's teaming with Science Commons, a project of the non-profit Creative Commons corporation, to build the industry's first neurology repository for the Semantic Web. The Semantic Web is a new technology that puts data into a machine-readable format so that computers can aggregate data and make inferences about relationships between certain types of data. It has applications across many life science arenas, including R&D, clinical trials, translational medicine, and personalized medicine. The project, dubbed NeroCommons.org, will be a freely accessible neurology commons of data, tools, and pathway knowledge to be used by both public and private researchers. Science Commons will use Teranode's XDA informatics platform as the infrastructure for NeuroCommons.org. All content will be available in RDF, allowing participating foundations to search and access a shared repository of data and research currently restricted by different formats and copyright restrictions. Teranode and Science Commons believe the repository will lower unintended legal and technical barriers to research, facilitate communication and materials usage between scientists, and increase innovation opportunities for accelerated research of new therapies for neurological diseases. For details, visit http://www.teranode.com.

Labtronics New LimsLink Release Provides Increased Lab Data Security

Labtronics Inc. has announced the release of LimsLink 4.0, the latest version of their laboratory instrument integration solution. LimsLink helps laboratories eliminate manual data entry by electronically transferring instrument data to their management systems, such as LIMS. This ensures the accuracy and security of the data and helps companies comply with regulatory guidelines such as FDA 21 CFR Part 11. LimsLink 4.0 was developed in response to the increasing number of large regulated companies utilizing LimsLink for their interfacing requirements. There is a growing need to implement LimsLink to a large number of users in different geographical locations while still maintaining compliance with data integrity regulations such as FDA 21 CFR Part 11. As a result LimsLink 4.0 has added many new and enhanced features that directly address these issues. LimsLink 4.0 enhancements allow customers to improve the security of their data and streamline set up and support of security configurations resulting in the most secure environment possible for their valuable laboratory data. LimsLink 4.0 also provides features that reduce network traffic and improve client to server ratio allowing customers to deploy LimsLink to more people wherever they are in the world without having a major impact on their existing IT infrastructure. For details, visit http://www.labtronics.com.

Labtronics Appoints William Bushey to Lead Implementation and Validation Services

Labtronics Inc. has nnounced the appointment of William Bushey as Project Manager. Reporting directly
to Robert Pavlis, President, Bushey will oversee Labtronics' Implementation and Validation Services. In his new role, Bushey will ensure that customers gain maximum benefit from their software investment and are in full compliance with all regulatory guidelines. He will lead Labtronics seasoned group of application experts and will have full responsibility for the success of all customer projects. Bushey brings more than 15 years of validation, IT and laboratory experience to Labtronics, with significant regulatory compliance expertise including vast knowledge regarding FDA 21 CFR Part 11, GAMP IV and cGMP. He joins the company from Novopharm where he served as Manager, Systems Validation. There he managed the validation project of Novopharm's Laboratory Information Management System (LIMS), was the local leader of a global initiative to create validation standards
according to GAMP IV guidance and remediation of existing cGMP-sensitive systems to adhere to 21 CFR Part 11 and represented the company in presentation and defense of validation documentation to regulatory agencies such as the FDA. Bushey has also managed the implementation of large Enterprise Resource Planning (ERP) systems for a number of companies, spent time as an implementation consultant for a software company and started his career as a chemistry laboratory technician at Upjohn Pharmaceuticals (now Pfizer). For details, visit http://www.labtronics.com.

ACD Opens European Office

Advanced Chemistry Development, Inc (ACD/Labs) has announced that they are expanding their direct presence in Europe by opening an office in the United Kingdom. ACD/Labs will now to able to offer a complete range of business and technical services, and provide a faster response to the needs of their customers. The new office in the UK will serve local pharmaceutical, chemical, environmental, and academic markets, providing customers with direct access to ACD/Labs' technical sales, support, and software development services. The UK office will be initially staffed with a team of professionals who have in-depth knowledge of the region, and who are already experienced with ACD/Labs products. ACD/Labs will now be able to offer a complete range of business and technical services, and provide a faster response to the needs of their customers. The United Kingdom has traditionally been an important market for ACD/Labs' specialty software products for analytical, organic, and other areas of chemistry, with installations at many leading chemical and pharmaceutical R&D organizations. ACD/Labs' UK customers include Pfizer, Oxford University, University of Cambridge, Quest International, AstraZeneca, and GSK For details, visit http://www.acdlabs.com.

What's New - January to February 2006 The following is a wrap-up of news of interest during the months of January to February 2006

What's New - January to February 2006
The following is a wrap-up of news of interest during the months of January to February 2006