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Document Control Systems Releases Updated MASTERControl Quality Management Suite The Web-based MASTERControl Quality Management Suite v4.0 from Document Control Systems Inc. (DCS) allows companies to automate document-based processes, such as change control and training control together with forms-based data collection processes, such as corrective actions and customer complaints, under a single, integrated Web portal. The MASTERControl Quality Management Suite v4.0 contains MASTERControl Portal, MASTERControl Documents, MASTERControl Forms, MASTERControl Training, MASTERControl CAPA, MASTERControl PDF Publishing, MASTERControl Collaboration, and MASTERControl Submissions. The MASTERControl Portal has been updated to include several key features, including My Recent Menu, which allows users to find documents or forms immediately. The menu displays a user’s 15 most recently viewed documents or forms with the click of a menu button. Additionally, users can place an external link to a controlled form process such as CAPA (corrective action and preventive action), personal time off request, customer complaint, or ideas program. This external link can be sent in an e-mail or provided on a common Website. The customer maintains complete control over external links and can choose whether the external link requires authentication and displays the MASTERControl login or is anonymous. The MASTERControl Portal also now supports an out-of-office designation with notifications. The My Tasks menu has been enhanced to provide users with even more information about the tasks that require their input. Changes also have been made to MASTERControl Training, including process triggers to ensure that training tasks are completed on time. Another feature is robust reporting. The software provides reporting and charting of real-time data based on current status of all training tasks and incident reporting. In addition, all changes between documents, such as standard operating procedures (SOP) and their associated training courses, are synchronized to ensure quality and compliance. The new My Training inbox has been added to provide trainees with an accessible location to view day-to-day training tasks and records that need to be completed. MASTERControl Training and the entire MASTERControl Quality Management Suite use electronic signatures for trainees to sign off when tasks are completed. MASTERControl Forms automates and manages quality processes that require collection of data captured on a form, such as audits, complaints, deviations, or any nonconformance issues from initiation to closure. With MASTERControl CAPA best practice CAPA form templates are available that can be used as is or customized to a company’s specific workflow process. CAPA and other forms-based processes can be linked with other MASTERControl processes as a closed-loop solution to automate incident reporting, solution identification, document change if required, employee training as required, and ongoing tracking to ensure process improvement. Organizations can connect an entire quality system as one automated, closed-loop solution, says Brian Curran, VP of Strategic Marketing and Product Management at DCS. Decision Resources and PharMetrics Offer Interactive Disease Analysis Product Decision Resources Inc. and PharMetrics have teamed up to enhance the way pharmaceutical companies analyze disease markets. The combination of PharMetrics’ rich data sets with Decision Resource’s analysis and interviews with thought-leading physicians provides biopharmaceutical companies with an in-depth view of what is truly happening in a disease market and why. The result of the partnership is DecisionMETRICS, a product that allows companies to accurately assess potential market size and identify untapped patient populations; identify key leverage points that can be used to effectively position a product; identify patient groups that provide the most opportunity, and refine messaging to drive desired patient behaviors; and assess the impact of emerging therapies and anticipate future dynamics in the marketplace to take preemptive action. DecisionMETRICS covers a wide selection of therapeutic areas, including metabolic diseases, central nervous system disorders, and immune and inflammatory diseases. DecisionMETRICS combines epidemiological, patient-level, and primary-market research data into one comprehensive package, says Michael Weintraub, President and CEO of PharMetrics. We can provide a more in-depth view of what is truly happening in a disease market and why to more accurately project what is most likely to occur in the next two years, says Sarah Fuller, President of Decision Resources. MD Net Guide Adds Five New Specialties to Its electronic newsletter Series In a move that almost doubles the size of its eDigest series of electronic newsletters, MD Net Guide has launched six new titles for bimonthly publication in 2005. Covering new developments in cardiology, endocrinology, gastroenterology, pediatrics, rheumatology, and urology, the newsletters are e-mailed, free of charge, to board-certified doctors who subscribe to the newsletters. All 11 eDigest publications are designed to help physicians keep up to date with the wealth of medical information on the Internet. In addition to publishing specialty-specific news and medical breakthroughs, eDigests offer CME listings, clinical-trial announcements, upcoming events, PDA downloads, product updates, and other important resources. “Through the expanded eDigest series, we are now able to offer an e-mail based newsletter for each of our specialty publications,” says Tighe Blazier, general manager of Intellisphere LLC, MD Net Guide’s parent company. “Specialists are under severe time constraints, and they need information that is accurate and current so that they can deliver the best possible patient care.” The eDigest format provides a structure that is easy to access, yet focused entirely on the doctor’s area of interest, says Tighe Blazier, General Manager of Intellisphere LLC, MD Net Guide’s parent company. New Electronic and Web-based Applications, Sites, and Technologies Thomson Releases New Research Tool for the Pharmaceutical and Biotechnology Industries The Thomson Corp. has introduced Thomson Pharma, an information solution designed to improve the workflow of the drug-discovery and development process. It provides research tools that fulfill the information needs of professionals working at all stages of the drug-development pipeline. Thomson Pharma was conceived and designed based on feedback from more than 11,000 customers ranging from large pharmaceutical organizations to start-up biotechnology companies, collected over eight months in 2004. “It is this type of feedback that drove the development of Thomson Pharma, and we continue to maintain our work with customers to evolve the product,” says Ian Tarr, executive VP, pharma and chemical markets, at Thomson Scientific. “We accepted the challenge to create a resource that would break down the information barriers to the business-critical content necessary for our customers to maintain a competitive advantage.” Thomson Pharma integrates trusted information from Thomson Scientific with critical content from other information businesses across Thomson, including content from its financial, healthcare, and legal and regulatory groups. The core Thomson Pharma content areas include drug information, intellectual property data, literature and news, company data, chemical information, sequence data, and drug target information, enhanced with value-added content resources and powerful search tools. Thomson Pharma provides researchers and other professionals in the fields of biology, chemistry, licensing, business development, and competitive intelligence with content derived from well-known legacy products, such as Investigational Drugs Database (IDdb), Derwent World Patents Index, Delphion, Web of Science, Drugdex, and many others. Thomson Pharma provides professionals worldwide with access to pharmaceutical-related information and news, says Ian Tarr, Executive VP, Pharma & Chemical Markets, Thomson Scientific. Fast Track Systems Enhances Trialspace Grants Manager Trialspace Grants Manager, a benchmarking and budgeting application from Fast Track Systems Inc., includes new features that give clinical and contracting professionals in pharmaceutical and biotechnology companies more control over predicting and managing investigator costs and budgets for clinical trials. Originating from Fast Track’s offline, desktop-based benchmarking product PICAS, TrialSpace Grants Manager provides a comparative industry view of trial-payment data for use in the clinical-trial budgeting process. By offering the largest and most comprehensive compilation of industry-based grants and protocols available, TrialSpace Grants Manager speeds up the negotiation cycle by revealing comparable payment data that are critical to clinical-trial budgeting. The enhancements include a grant total calculator as part of the investor planning tool. Users can simply create custom calculations of estimated trial costs and attach comments for reference and review. The per-visit budget enhancement allows users to assign multiple screening visits, discontinuation visits, withdrawal visits, associated follow-up visits, as well as assign a procedure to all visits. Other capabilities include direct export of all country budgets into Microsoft Office Excel with formulas preserved and full worksheet formatting. Lilly Launches Online Clinical-Trial Registry Eli Lilly and Co. is launching a publicly available clinical-trial registry, lillytrials.com, which will post the results from all Phase I through Phase IV clinical trials of its marketed products. Additionally, the company will post information on the initiation of all Lilly-sponsored Phase II through Phase IV clinical trials via the Website registry. “The Lilly registry will be the most comprehensive effort to date, by either a public or private entity, to publicly disclose clinical-trial information,” says Alan Breier, M.D., VP and chief medical officer of Lilly. “We believe the Lilly registry will become a tremendous resource for physicians and healthcare providers seeking important information about clinical research involving Lilly medicines.” For each clinical trial of its marketed products, the company will publicly disclose the results corresponding to the study’s predefined primary and secondary outcome measures that are specified in the study protocol, as well as additional safety and efficacy results that affect patient care and the clinical use of Lilly products. Results that do not support the hypothesis being tested or that are contrary to the expected outcome also will be disclosed. Additionally, Lilly will post a comprehensive description of the trial design and methodology for each study. A listing of all Phase II, III, and IV clinical trials will be posted on the registry at the initiation of each trial using a unique numerical identifier, trial descriptor, phase, trial start date, projected end date, and trial status. When a trial is completed and the drug is commercially available, the results of the trial will be affixed to its identifier. Lilly already posts serious and life-threatening studies to the government’s Website, clinicaltrials.gov. The company will populate the government site with all Lilly-sponsored Phase II, III, and IV clinical trials, regardless of the disease or condition being studied. For Phase I, II, and III studies, Lilly will disclose clinical-trial results when a drug’s indication is approved and the drug is commercially available. Additionally, Phase III trial results for secondary indications of marketed drugs that fail to support the hypothesis being tested or that are contrary to the intended outcome will be disclosed as soon as possible after the data analysis is completed but not later than one year after the trial is completed. Phase IV trial results also will be disclosed as soon as possible after the data analysis is complete but no later than one year after the trial is finished. For studies that are under review by a peer-reviewed journal that prohibits prepublication disclosure of results, the results will be posted on the registry at the time of publication. In addition to posting clinical-trial results online, the company will seek to disclose results through a peer-reviewed medical journal, subject to the discretion of the journal editors. The company will commit to providing a reference in the clinical-trial registry for study results that are disclosed in a peer-reviewed journal. In addition, Lilly’s clinical-trial results may be disclosed through presentations or abstract submissions at professional scientific meetings. Implementation of these standards will begin with all clinical trials for marketed products that were completed after July 1, 2004. In addition, the registry will be populated retrospectively with results of core efficacy and safety registration trials of marketed compounds approved since July 1, 1994. The company will assign an independent third party to audit and verify adherence by Lilly to these standards of disclosure. Dr. Breier adds that lillytrials.com is populated with nearly one-half of the data the company has committed to make publicly available. Some additional results are complete, but are not currently being disclosed due to pending publication. Other outstanding data are being gathered and entered to fully populate the registry Website by no later than July 2005. The Lilly registry will be the most comprehensive effort to date, by either a public or private entity, to publicly disclose clinical-trial information. ICM Addresses SARBANES-OXLEY COMPLIANCE DEMANDS ICM Corp. has launched Cougar v1.0, a complementary product to its Leopard platform. Cougar v1.0 helps pharmaceutical and other FDA-regulated companies to manage the extensive work required to comply with sections 302 and 404 of the Sarbanes-Oxley Act. Cougar v1.0 offers the following functions: document and information management; process automation and workflow; communication and collaboration; monitoring and reporting, configuration practices; and system documentation and administration tools. With Cougar v1.0 users gain real-time visibility into processes, risks, and controls from a single point of access, and they can manage and use information to effectively make decisions, not just collect data. In addition, the product helps reduce costs by facilitating and accelerating the compliance process, and it establishes a flexible foundation for longer-term compliance initiatives. “The Sarbanes-Oxley Act is not just a one-time compliance exercise,” says Ramon Dempers, president and CEO of ICM. “It is a new way of doing business that forces executives to anticipate risk and manage it carefully.” Cougar v1.0 is an ongoing, long-term solution that helps a company implement permanent and positive change to its compliance approach, says Ramon Dempers, President and CEO of ICM. Wolters Kluwer Health Launches New Medication Order Management Database Wolters Kluwer Health is offering a Medication Order Management Database (MOMD) to support computerized prescriber order entry (CPOE)/e-prescribing applications. MOMD provides clinically relevant medication orders, otherwise know as “sigs” or dosing instructions, to ensure patients are prescribed the most appropriate dose based on a given drug and set of clinical parameters. This will help to reduce the thousands of medical errors that occur every year in the United States. This latest offering from Medi-Span, a provider of drug information databases from Wolters Kluwer Health, enhances CPOE and e-prescribing applications by incorporating clinical parameters such as patient age, weight, renal function, indication, route of administration, and special conditions. In addition, MOMD offers the ability to set multiple user preferences, such as one that allows a user to specify the number of sigs retrieved and one that provides the option to return sigs in terms of dose (5 mg) and/or dosage form (1 tablet). “We are extremely pleased that the Medication Order Management Database will provide users with the most robust solution available on the market today,” says Ken Killion, CEO of Wolters Kluwer Health’s clinical tools business unit. As a flat file database, MOMD can be integrated with vendor or self-programmed systems. Incremental and full database updates are available weekly and monthly via CD-ROM or telecommunications. Wolters Kluwer Health is offering a Medication Order Management Database (MOMD) to support computerized prescriber order entry (CPOE)/e-prescribing applications. Vision Integration Partners Initiates Medical-Education Portal Vision Integration Partners LLC has launched drsvp.com, a Web-based technology that optimizes the communication between physicians and pharmaceutical companies that sponsor medical-education events. The Website provides a secure online environment where physicians can view and reply to pharmaceutical company-sponsored medical-educational events posted on the medical professional’s Web-based calendar. This application is expected to significantly reduce pharmaceutical companies’ administrative and marketing costs paid to third-party vendors, as well as their representatives’ time-off territory, now required to coordinate such events. Busy physicians are able to find all of these events on one site, reply to the event, view the speaker credentials, set preferences, get directions, and give instant feedback to sponsoring companies before and after the event. The portal also addresses ethical matters within the pharmaceutical and medical fields. The Pharmaceutical Research and Manufacturers of America (PhRMA) and the American Medical Association (AMA) have developed strict guidelines that regulate how information can be disseminated between pharmaceutical reps and healthcare professionals. As it relates to medical education, drsvp.com assists in supporting these guidelines by serving as an independent clearinghouse for educational forums using pre-approved templates. “Pharmaceutical sales representatives must sacrifice a considerable amount of time out of their territory to plan, organize, and subsequently recruit physicians to attend company-sponsored educational events,” says M.J. Meinert, founder of Vision Integration Partners. “The increased administrative duty involved in this process takes away from the representatives’ time in front of physicians when they should be discussing their product, instead of recruiting the physician for the next educational event.” Many pharmaceutical companies leave it up to the representative to make up their own invitations to events without prior legal approval, a practice that can result in significant legal exposure and uncontrolled administrative costs. Drsvp.com allows them to manage invitations, speaker logistics, and surveys all on one site. Likewise, busy physicians and their staff members are faced with multiple program requests from virtually every major pharmaceutical company and must spend a significant amount of time and staff resources dealing with the numerous phone calls, unsolicited faxes, and unscheduled representative recruitment visits. Drsvp.com provides a single, comprehensive solution for both parties to interact for a fraction of what most companies are currently spending on these programs. Drsvp.com provides an integrated solution to pharmaceutical companies’ existing platforms without the advertisements, says M.J. Meinert, Founder of Vision Integration Partners. SciQuest Adds Reverse Auction and Supplier Management Functionality to Sourcing Manager SciQuest Inc. has added an on-demand bid-management solution that helps organizations achieve significant process efficiencies and cost savings over the traditional paper-based bid process. The newly added functionality enables an organization to conduct real-time reverse auction events, including creating an auction, inviting suppliers, previewing the auction, monitoring and controlling the auction, tabulating auction responses, graphing auction results, and archiving auction history. A supplier portal also is provided that allows suppliers to manage their profiles, view events, enter responses, send messages, and see their awarded items. Key features include: robust event controls for pricing, rank display, and timing, which allow buyers to manage the bidding environment ensuring suppliers are on a level playing field; real-time status monitoring for buyers and suppliers; an online evaluation functionality to allow buyers to compare supplier responses; a supplier portal that removes supplier information management burden from the purchasing staff; and a dynamic negotiation process through which suppliers are presented with their current position in the auction. This enhanced solution streamlines the bidding process with real-time controls and provides purchasing agents with increased supplier management features, says Steven J. Wiehe, President and CEO of SciQuest. CapMed Offers Software Applications To Help Patients Track and Manage their Health CapMed, a division of Bio-Imaging Technologies Inc., is targeting hospitals, pharmaceutical companies, insurers, and employers to distribute health-management tools that encourage patients to take an active role in their healthcare. These organizations are reaching critical audiences, from patients with chronic conditions to generally healthy patients. CapMed’s Personal Health Record is a software application that enables users to manage and store personal health information on the privacy of their desktop computer, while linking directly to sponsor-directed resources, such as drug information, patient education, or disease guidelines. The software application originates from a physician’s medical record, allowing information to be tracked in a problem-oriented format. This allows for information, such as medical images, to be tied directly to the problem or condition for which they relate. The Personal HealthKey is a key-chain data storage technology and autolaunching software that plugs into a computer’s USB port, allowing patients to easily and securely transport specific health reports or their entire medical record, including diagnostic medical images, anywhere. With the Personal HealthKey, doctors and patients can easily access medical records without the need for additional hardware or software. Patient-selected emergency information or patient-registration information can be designated to automatically launch when the HealthKey is inserted into the USB port. In addition, data encryption and password protection let the user decide which information to share. By some accounts, poor access to medical information is to blame for almost 100,000 patient deaths each year from medical errors, according to the Institute of Medicine. In addition, information availability has often been blamed for inefficiencies in the healthcare system, such as redundant testing and red tape. These inefficiencies, combined with other problems, account for $1.6 trillion spent on healthcare each year. According to Wendy Angst, general manager of CapMed, the lack of timely access to a patient’s medical information is both dangerous and costly, especially in the event of an emergency situation. “Our products were designed to address this problem,” Ms. Angst says. “Electronic personal health records may answer a problem that is all too apparent in the United States where 85% of medical providers rely on archaic paper charts for record keeping, leaving the patient to recall pertinent medical information, often in times of crises. This paper-based information is often illegible, subject to delays, difficult to interpret, frequently misplaced or lost, and contributes to unnecessary costs.” According to industry reports, while healthcare has adopted information technology for financial and administrative systems, it has made limited progress in using information technology to support patient care. While the dissemination of PHRs is still in its early phase, research shows a strong consumer interest and demand. In 2004, Harris Interactive surveyed 2,500 Americans and found two in five adults in the United States keep their own personal and family health records. In the same survey, 84% of all participants welcomed the concept of personal health records. We hope to encourage the growing patient interest in monitoring their health and the health of their families. With these tools, we believe we can help to minimize unnecessary healthcare costs, avoid medical errors, and even save lives, says Wendy Angst, General Manager of CapMed. Patient Interaction Launches Online Clinical-Trial Recruitment and Retention service Patient interaction (Pi), a division of First Marketing, has launched (Pi)SiteSource, a clinical-trial recruitment and retention product designed to help shorten the clinical-trial stage of product development. “By boosting site recruitment and retention performance, (Pi)SiteSource can help avoid costly delays, giving sponsors a competitive edge,” says Ron Drenning, president of First Marketing. (Pi)SiteSource accommodates a sponsor’s need to maintain control over messaging and IRB-approved content, but addresses the sites’ desire for flexibility and choice in the vehicles they use for recruitment and retention. The technology employed also makes it possible to customize the materials ordered with individual contact information as well as a photo of the lead investigator or the site logo. Back-office reporting lets the sponsor view site usage of the system and link these data with actual study enrollment and retention rates. Through analysis of these performance metrics, sponsors can quickly make informed decisions regarding resource allocation. Since sites only order the materials they need, the online ordering system also eliminates the need for expensive bulk quantities and inventory storage. The site itself, as well as consumer materials, is available for foreign language translation. The online ordering system allows clinical-trial sponsors to manage centrally, yet execute locally, says Ron Drenning, President of First Marketing. ICTI Announces Improved Statistical Services Interactive Clinical Technologies Inc. (ICTI) is offering improved statistical services designed specifically to support adaptive randomization trial designs. The nature of such trials mandates the use of IVR systems. The offerings include statistical consultation during randomization algorithm design for sponsors, computer-enhanced blackbox testing of adaptive randomization algorithms, and adaptive randomization modeling services for pre- and post-live study analysis. ICTI’s new statistical services were developed in response to the industry’s need for more complex trial designs and randomization schemes, says Eva Miller, Ph.D., ICTI Manager of Biostatistics. Follow up Capmed, Newtown, Pa., a division of Bio-Imaging Technologies Inc., provides hospitals and health systems, employers, and pharmaceutical organizations with custom personal health management solutions, marketing tools, and e-health strategies to increase market share, reduce cost of care, improve patient-provider communications, and empower patients to be more active in personal health management. For more information, visit capmed.com. Decision Resources Inc., Waltham, Mass., provides research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. For more information, visit decisionresources.com. Document Control Systems Inc., Salt Lake City, provides electronic content management and quality management systems to life-sciences companies. For more information, visit mastercontrol.com. Fast Track Systems Inc., Conshohocken, Pa., provides a data-driven systems approach to expediting clinical-trial design, setup, and execution. For more information, visit fast-track.com. ICM Corp., Roswell, Ga., is a software development company that provides compliance management products to companies regulated by the Food and Drug Administration. For more information, visit icm-corporation.com. Intellisphere LLC, Plainsboro, N.J., publishes MD Net Guide, a peer-reviewed series of medical journals that cover the nexus of healthcare and technology exclusively for physicians, and its related eDigest family of e-mail newsletters. For more information, visit mdnetguide.com. Interactive Clinical Technologies Inc. (ICTI), Yardley, Pa., specializes in the implementation of interactive trial-management solutions. For more information, visit icti-global.com. Eli Lilly and Co., Indianapolis, is an innovation-driven pharmaceutical company developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. For more information, visit lilly.com. Patient interaction, Pompano Beach, Fla., a division of First Marketing, helps facilitate, accelerate, and enhance the study enrollment and retention process. For more information, visit patientinteraction.com. PharMetrics, Watertown, Mass., provides market intelligence solutions to the pharmaceutical, biotech, medical-device, and health-plan sectors of the market using anonymous patient-centric data. For more information, visit pharmetrics.com. SciQuest Inc., Research Triangle Park, N.C., provides on-demand solutions that integrate organizations with their suppliers to enable comprehensive spend management for the life-sciences and higher education markets. For more information, visit sciquest.com. Thomson Corp., Stamford, Conn., provides integrated information solutions to business and professional customers. For more information, visit thomson.com. Vision Integration Partners LLC, Pittsburgh, delivers professional Web services to pharmaceutical companies and physician organizations. For more information, visit visionintegration.com. Wolters Kluwer Health, Chicago, provides information for professionals and students in medicine, nursing, allied health, pharmacy, and the pharmaceutical industry. For more information, visit wkhealth.com.

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