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New Electronic and Web-based Applications, Sites, and Technologies
Phase Forward Offers Enhanced Trial-Management Tools Phase Forward Inc. has released the new InForm Adapter module, providing customers with enhanced integration capabilities for its InForm Integrated Trial Management (ITM) electronic data capture (EDC) solution. The InForm Adapter module allows users to leverage a set of Web-services interfaces to access data and event information stored in the InForm database. The result is a broader set of integrated and extensible clinical workflow solutions that better leverage users’ existing proprietary systems and packaged applications. The InForm Adapter module also enables customers to build routines that leverage their study data and events to interoperate with other business systems, such as clinical, custom, financial, ERP, and inventory management systems. Available interfaces include: operational data management (ODM) export interface; discrepancy interface; event interface; and coding interface. In related news, Phase Forward has also released version 1.5 of its Web Submission Data Manager (WebSDM) product. This data-review solution streamlines operations with submission-ready files for clinical-trial data. Initially released last fall, WebSDM is an FDA submission review tool that was originally developed by Lincoln Technologies in collaboration with the FDA. The new release incorporates the newest Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulations Model (SDTM) standard, version 3.1.1; enhanced Define.XML support; and improved validation and edit-checking functions. WebSDM allows users to load and validate CDISC SDTM-formatted clinical-trial data files, browse them using standard views, access and analyze patient profiles, and prepare files for regulatory submission. The product’s enhanced enterprise capabilities offer next-generation collaboration and data sharing between stakeholders throughout the clinical development process, addressing the needs of manufacturers, clinical research organizations (CROs), affiliates, and regulatory reviewers. Our goal is to help customers adopt clinical-data standards as part of their clinical-data management, analysis, and safety evaluation cycle, says Bob Weiler, President and CEO, Phase Forward Inc. PI Offers Online Training Infrastructure The Pharmaceutical Institute (PI) has launched the Corporate Academy Program, the first complete online training infrastructure for pharma and biotech companies. The Corporate Academy Program was designed to allow companies to develop their own “online universities” by providing the training infrastructure companies need, without the cost and commitment required to build one from the ground up. The Corporate Academy Program can provide clients a training infrastructure and learning environment with custom content and skilled management. The program’s four key components include: a curriculum covering functional and therapeutic areas developed by PI along with business courses developed by a top-tier business school; a value-added online learning management system (LMS) that serves as a centralized point of access for all training resources; ongoing support in communicating the value of training programs, training corporate users, tracking and managing access, and technical support; and custom course development. The Corporate Academy Program can be deployed companywide or for individual departments and teams. Managers can take advantage of the program’s benefits without having to commit to an enterprisewide solution. The Corporate Academy Program can provide clients a training infrastructure and learning environment with custom content and skilled management. Octagon Launches Series of Next-Generation Submission Solutions Octagon Research Solutions Inc. has unveiled ViewPoint 3.6, the latest version of its enterprise submission process-management solution, for handling complex, cross-functional processes in support of regulatory submissions. ViewPoint streamlines the submission process by providing visibility into the planning and management of the drug-submission processes, while allowing users to track, manage, and compile any type of regulatory application. In version 3.6, the solution’s Resource Estimator, Reviewer, and Regulatory Dashboard have been enhanced to provide workflow estimation, collaboration, and project-tracking across the submission life cycle. Additionally, the company has released eCTD Suite 2.0, including the eCTD Viewer and eCTD Validator. This suite offers viewing and validation capabilities, limiting the risk of missing a submission date or filing an incomplete or noncompliant eCTD submission. Octagon also has unveiled eCTD JumpStart, an offering comprised of documentation and services designed to accelerate compliance with electronic regulatory submission regulations worldwide. Building on its StartingPoint eCTD template suite, eCTD JumpStart helps companies move beyond well-formatted documents to creating a solid eCTD foundation. The offering includes a style guide; document naming conventions; a folder structure for storing and managing regulatory submission documents; and bookmarking and hyperlinking standards. Additionally, it includes consulting services that address how document processes can pull together all of these standards to facilitate the efficient creation, management, and retrieval of submission-ready documents. Octagon has released StartingPoint 2.1, the latest version of its template tool. StartingPoint includes: a master template, which defines formatting and automation functionality; more than 170 authoring templates across all five CTD modules; validation test scripts; and a comprehensive user guide. In related news, Octagon has formed a strategic partnership with Adlib Software. Through the alliance, Adlib’s document transformation engine now augments Octagon’s suite of products for managing complex, cross-functional processes in support of regulatory submissions. Yesterday’s paper-based technologies and processes cannot deliver the efficiencies and intelligence that pharmaceutical and biotech companies need to make effective decisions about their submissions and execute them in real-time, says Jim Walker, CEO and Chairman, Octagon Research Solutions Inc. PRA International Introduces Hybrid Data-Management System PRA International has released Flex DMS, an advanced, clinical data-management system that combines electronic data capture (EDC) and paper data entry (PDE) in one easy-to-use system. “In trials where EDC is used exclusively, traditional study timelines can often be cut in half, if not more,” says Greg Johnson, PRA’s VP of data management. “With Flex DMS, we are capturing some of that efficiency even with studies that mix EDC and PDE, enabling us to deliver more timely and accurate results to sponsors. In the near future, we will provide clients with real-time access to study data as well.” Flex DMS has received Microsoft’s Pharmaceutical and Life Science Technology Innovation Award in the Clinical Development category. The system is currently supporting about 20 studies in various stages of development. While EDC is rapidly gaining acceptance among the medical-investigator community, there is still a need to manage paper reporting in as efficient a manner as possible, says Greg Johnson, VP, Data Management, PRA International. Thomson Scientific Releases Training and Competitive Intelligence Tools Thomson Scientific has launched Regulatory Online Learning, a Web-based resource for regulatory-intelligence training. Regulatory Online Learning integrates with IDRAC, a global regulatory-intelligence database. Users have access to expert instruction designed to provide unparalleled training in global regulatory affairs and to optimize success when dealing with regulatory authorities. The Regulatory Online Learning modules now available include: Introduction to European Union institutions and regulatory authority (EMEA); Introduction to U.S. institutions and regulatory authority (FDA); Introduction to Japanese institutions and regulatory authorities; and How to Register Medicinal Products through the Centralized Procedure. Thomson Scientific plans to launch 12 additional modules later this year. Further modules will be added subsequently. The modules cater to three levels of expertise: introductory, practical (to include case studies), and strategic. Online learning modules are developed by IDRAC experts, assisted by an internationally recognized network of consultants and partners. Content of all modules is continually updated and complemented by an e-testing capability that enables online knowledge testing after each module has been completed. In related news, Thomson Scientific has released the Thomson Pharma Generic Competition Module, a strategic tool for research-based innovator, specialty, and niche-brand pharmaceutical companies. The Generic Competition Module enhances Thomson Pharma, a drug-discovery and development information solution for professionals at all stages of the drug-development pipeline. The new module provides critical, early intelligence and independent analysis to help companies identify and assess the earliest signs of generic competition for brand products. The Generic Competition Module enables product life-cycle management teams to forecast loss of product exclusivity, to quickly identify competition, and to assess the potential effects of generic entry on their competitor’s products. Thomson Pharma also has been enhanced with a Pharma Regulatory Affairs Module. This new module provides regulatory, legal, and scientific information for development and registration of medicinal products and biologics. The Thomson Pharma Generic Competition Module answers the concerns of innovator companies by providing the critical information they need to determine and assess the likely source, impact, and timing of potential generic competition, says Jon Brett-Harris, Executive VP of Pharmaceutical and Chemical Markets, Thomson Scientific. OmniComm Systems Updates Clinical Trial Solution OmniComm Systems Inc. has released TrialMaster version 4.0, an e-clinical trial solution. In updating the solution, OmniComm focused on simplifying trial building, streamlining data-entry processes, and integrating technology to optimize the e-clinical trial process, says Rusty Beardsley, OmniComm’s executive VP, commercial development. The latest release includes e-data capture functionality, data-management functionality, trial-management functionality, and easy trial-build capability. The update offers clients more speed, more flexibility, and more control of their data in the business model of their choice — ASP, technology transition, or technology transfer. In updating the solution, OmniComm focused on simplifying trial building, streamlining data-entry processes, and integrating technology to optimize the e-clinical trial process. Oracle and DrugLogic Unify Solutions for Adverse Event Reporting Oracle Corp. has integrated DrugLogic’s Qscan with its Adverse Event Reporting System (AERS) to create a best-of-breed, enterprise risk-management architecture. The combined solution leverages advanced analytics to help enhance safety-monitoring capabilities and streamline compliance with pharmacovigilance requirements. Qscan is DrugLogic’s workflow-based analytical tool for identifying, analyzing, and resolving drug-safety risks. The solution works seamlessly with Oracle AERS’ case data, as well as data from external sources, such as the U.S. Food & Drug Administration and the World Health Organization. The combination allows pharmaceutical and biotechnology companies to generate safety signals from adverse-event data earlier and faster than before. Oracle AERS pharmacovigilance users can now visualize their case data in Qscan and use Qscan’s powerful data-mining and signal-detection capabilities to focus on the cases of most interest. Additionally, drug-safety teams can establish thresholds for automatic safety-signal detection, receive alerts when thresholds are reached or exceeded, and assess their case information using data-mining tools for statistical analysis. Qscan integration also gives users the ability to immediately investigate any adverse-event data against publicly available data sources. Drug-safety teams can monitor and analyze — in a single view — legacy, clinical, and pre- and postmarket adverse-event data. Oracle AERS, together with Qscan, equips pharmaceutical and biotech companies with a powerful lens to rapidly analyze patterns in adverse events that may indicate emerging drug-safety risks pre- and postmarket, says Mychelle Mowry, VP, Global Health Industries, Oracle. PDS Launches Updated Clinical Trial EDC Solution Phoenix Data Systems Inc. (PDS) has released Express 4, an updated version of the company’s EDC application. Express 4 is designed to help life-sciences firms and clinical research organizations (CROs) efficiently capture, clean, and manage data in clinical trials of all phases. As with previous versions, the PDS solution includes an automated coding utility and the PDS Reportal — a graphing, reporting, and real-time trial process visualization module. Interactive voice response (IVR) capabilities also have been added to the application suite. Additional enhancements include: • Net framework, offering streamlined deployment, enhanced interoperability with diverse systems, and improved update capability • The PDS AutoEncoder, a medical dictionary tool that streamlines coding • Seamless CRF version management, including automatic data migration and updates • User-interface improvements, such as side-by-side form review, increased graphical content, form-locking flexibility, enhanced form marking, hot keys for power users and data entry, and listings and subject views • Program user administration • Anywhere/anytime data collection and cleaning • Lab data capture and management, which automatically processes local and central lab data, integrating it into the CRFs and making it available for review and analysis in real-time • Enhanced reporting functionality • Improved security and privacy compliance, including object-level permissions, complex passwords, and roaming profiles The updated version of Express extends the ease of use and leading EDC functionality, providing greater flexibility for study setup, user and site management, and user-interface enhancement, says Doug Cory, VP, New Product Development, Phoenix Data Systems. Medidata and Cytel Integrate EDC Platform for Clinical Trials Medidata Solutions Worldwide Inc. and Cytel Inc. have integrated Cytel’s FlexRandomizer patient randomization engine into Rave, Medidata’s Web-based electronic data capture (EDC) system, to offer clinical-study sponsors the ability to randomize patients in all types of trials — both traditional and adaptive — directly through an EDC system. The integration allows sponsors to: check randomization and eligibility criteria uniformly across all investigator sites; monitor accrual of study patients in real-time; and adjust treatments based on patients’ dose responses or other adaptive algorithms. Additionally, all randomization data is securely maintained within one system. These features result in increased efficiencies in study conduct, reduced costs, and most importantly, increased patient safety. Cytel’s dynamic randomization engine provides Medidata Rave users the flexibility to not only perform randomization for traditional trials but also to quickly and reliably implement adaptive clinical trial designs, says Glen de Vries, chief technology officer, Medidata Solutions Worldwide. DMS Launches Clinical Trials Database DMS Data Systems has launched Clinical Trials Plus, a searchable online database of clinical trials designed to support business development, clinical development, competitive intelligence, and investment professionals in the life sciences. The database contains all clinical trials registered with clinicaltrials.gov, the largest clinical trials registry in the world. It has powerful search features and allows users to set up e-mail alerts tracking new trials on any subject and to create PDF documents from the results of their searches. The database, which is updated daily, also contains links to related industry news and company profiles. “Our databases provide current and comprehensive content and the software to search, display, and track that content,” says Dr. Rick Franklin, chairman of DMS Data Systems. “The NewsAnalyzer and IndustryAnalyzer have proved to be important tools for business development and analysis, and I am sure that Clinical Trials Plus will provide substantial additional value.” The database contains all clinical trials registered with clinicaltrials.gov, the largest clinical-trials registry in the world. Datafarm Releases Web-Based eCTD Tool Datafarm Inc. has released eCTDViewer Web Edition, version 3.0. This Web-based solution for viewing electronic common technical documents (eCTD) includes support for all recent eCTD specifications and guidelines published by U.S. Food and Drug Administration, the European Medicines Agency (EMEA), and the International Conference on Harmonization (ICH), as well as Japanese, Canadian, and Taiwanese regulatory agencies. eCTDViewer Web Edition is built upon recognized technology standards such as HTML, XML, and JAVA. This combination of cross-platform technologies makes the application easy to deploy on both Windows and Linux servers and allows it to support multiple application servers, such as BEA WebLogic and Apache Tomcat. By using this standards-based approach, Datafarm has made it possible for any organization, regardless of size, to seamlessly incorporate eCTDViewer Web Edition into their existing environment. eCTDViewer Web Edition is built upon recognized technology standards such as HTML, XML, and JAVA. Decision Resources Offers Competitive Analysis Tool Decision Resources Inc. has released DecisionBase 10, an interactive decision tool that reveals the commercial opportunity of drugs in development and on the market. The database, which allows pharma and biotech organizations to compare those drugs with their own proprietary compounds, covers 35 diseases in a variety of therapeutic areas, such as cardiovascular, central nervous system, oncology, immune and inflammatory disorders, infectious disease, psychiatric diseases, metabolic disorders, and other disease states. DecisionBase 10 allows users to: access information about, and evaluate the potential for, a specific drug or disease; drill down to a rich data set to understand current treatment and market dynamics; and compare and contrast the unmet need and opportunity for a proprietary drug against the future gold standard. New to DecisionBase 10 is the Target Product Profile methodology, which outlines a commercially compelling drug-development opportunity that is achievable within 10 to 15 years. Target Product Profiles build profiles of realistic, impactful drugs. With a two-stage survey methodology, analysts uncover what physicians want to treat a particular disease and then determine what types of enhancements to a current drug are necessary for the physicians to change their prescribing habits. Target Product Profiles allow pharma and biotech companies to discover which drug attributes present the greatest threat to their established drugs, as well as how to effectively enter a disease market with a new drug, says Sarah Fuller, President, Decision Resources Inc. CRF Enhances E-diary System for Clinical Trials CRF Inc. has launched TrialMax 3.2, a study-management tool that features advanced data-management capabilities for the electronic patient-reported outcomes (ePRO) market. This latest version incorporates functions that increase compliance, reliability, and accuracy of data collected in global trials. TrialMax 3.2 includes a more robust data transport feature, which allows for easier sharing of questionnaires among e-diaries. It also has greater capability to function in 57 languages through the use of software that captures the nuances of colloquial usage and dialect, greatly improving the ease of use for patients and the quality of data collected for researchers. “No other e-diary has software with the sensitivity needed to overcome the challenges of translating clinical-trial programs into multiple languages, enabling trial sponsors to test their product over a broad spectrum of populations,” says Pekka Keskiivari, CRF’s chief technology officer. The advanced individual components provide the tools necessary to create intuitive e-diaries that guide the patient through the study procedures, facilitating high rates of compliance and resulting in high-quality data. No other e-diary has software with the sensitivity needed to overcome the challenges of translating clinical-trial programs into multiple languages. DataLabs Launches Product for Managing System Integrations Clients can integrate their own best-of-breed suite of products using DataLabs Connect by either writing custom connectors or by leveraging the existing library of connectors. DataLabs Inc. has released DataLabs Connect v2.0, an enterprise-level middleware product built specifically for the biopharmaceutical industry. The solution includes an application server, management portal, connector framework, and predefined connectors that integrate the entire suite of DataLabs’ products, including Galt Associates’ dsNavigator encoding and dictionary-management product. The complexity of managing multiple point-to-point integrations increases exponentially as each new integration component is added. DataLabs Connect provides a common framework to support integrations with solutions based on open standards, such as CDISC and Web services, but it also provides a tool kit to integrate with proprietary systems, such as lab equipment and other legacy-type solutions. Clients can integrate their own best-of-breed suite of products using DataLabs Connect by either writing custom connectors or by leveraging the existing library of connectors. The product extends beyond the capabilities of many general purpose middleware products with the concept of a Master Resource Catalog (MRC) that serves as a central hub, brokering the communication of disparate systems. “The DataLabs Connect product is the culmination of the company’s years of experience in implementing and integrating its suite of solutions within its customers’ environments,” says Nick Richards, chief operating officer of DataLabs. In other company news, Datalabs has released Site Manager 2.0, a Web-based site-management software. Site Manager 2.0 is a communications portal that extends electronic data capture (EDC), which allows sponsors, clinical research organizations (CROs), investigator sites, and other trial participants to streamline data exchange and entry, document processing, and data management. With Site Manager 2.0, sponsors or CROs can quickly identify and initiate investigator sites and then monitor and administer the site during the course of the trial. The latest version of the solution streamlines clinical-trial efficiency by integrating CoSign, Algorithmic Research’s electronic signature solution. CoSign allows users to sign documents with secure, regulatory-compliant electronic signatures that complete the migration to paperless processes. SAS Drug Development Adds Genomic-Analysis CapabilitieS Extending the capabilities of SAS Drug Development to incorporate biomarkers into clinical research lays the groundwork for companies wanting to take the next step in bridging the existing silos of information between research and development, says Laurie Rose, Director of Global Health and Life Sciences, SAS. SAS has enhanced its flagship life-sciences offering, SAS Drug Development, with genomic-analysis capabilities. The new functionality makes it easier for pharmaceutical companies to analyze genetic data and incorporate the analysis into new drug applications. SAS Drug Development now includes more than 90 processes for genomic and proteomic-specific molecular analyses, addressing the areas of genetics, microarrays, and proteomics. The solution also provides a customizable, collaborative system to address biomarkers, which are a key component of the FDA’s Critical Path Initiative. It also enables organizations to easily incorporate molecular information into clinical decision-making, while allowing life-sciences organizations to facilitate regulatory compliance, meet requirements for traceability of analytical results, and simplify global collaboration. Spotfire Solution Powers Clinical-Trial Data Analysis Spotfire Inc. has unveiled a new analytic solution comprised of its DecisionSite software along with analytic services designed specifically for clinical trials. The new solution enables pharmaceutical scientists to visually analyze and interact with data from clinical trials, resulting in faster, more comprehensive analysis and better decisions about the risk and benefits of potential new therapies. The solution allows pharmaceutical scientists to: • Speed through outliers, trends, and relationships among increasingly complex adverse event and lab-safety data. • Build guided analyses to facilitate the consistent, systematic review of data. • Review data interactively in team meetings. • Easily incorporate new trial results to enrich the analysis and promote faster development. “Most analysis currently is paper- and table-based,” says Christian Marcazzo, senior director of life-sciences marketing at Spotfire. “We are introducing a significant shift to an analysis process that is visual, interactive, multi-dimensional, and collaborative. The result is a powerful way for pharmaceutical companies to speed the drug-development process and ensure drug safety.” Spotfire has unveiled a new analytic solution comprised of its DecisionSite software along with analytic services designed specifically for clinical trials. Skyscape Offers Point-of-Care CME Skyscape Inc. has launched Skyscape CME, an innovative program for earning continuing medical education (CME) credits. Based on the point-of-care (POC) model of CME formalized by the American Medical Association (AMA), Skyscape CME enables physicians to earn credits seamlessly while performing their daily clinical duties, including patient care and recording activities. By formalizing the certification and documentation of the self-directed learning, Skyscape has streamlined the process of continuing education, while simplifying the task of managing the board-licensing requirements. Most state licensing boards and specialty organizations in the United States require physicians to participate in at least 50 CME credits per year to maintain their medical license. The AMA has standardized educational requirements for physicians through its AMA Physician Recognition Award Category 1 Credit program. The newly launched CME service from Skyscape enables physicians to earn their required CME credits while continuing to use approved resources from Skyscape’s growing portfolio of more than 300 medical resources in more than 30 unique specialties. “CME is yet another building block in Skyscape’s overall mobile and wireless strategy to fully support healthcare practitioners with their complete decision support and compliance needs,” says Sandeep Shah, president and CEO of Skyscape. Continuing medical education is yet another building block in Skyscape’s overall mobile and wireless strategy to fully support healthcare practitioners, says Sandeep Shah, President and CEO, Skyscape Inc. Follow up Adlib Software, Burlington, Ontario, develops products for document transformation and document workflow automation. For more information, visit adlibsoftware.com. Algorithmic Research, Pleasant Hill, Calif., provides electronic signatures and data security solutions. For more information, visit arx.com. CRF Inc., Waltham, Mass., develops electronic patient-reported outcomes (ePRO) and wireless data-collection solutions for the biopharmaceutical industry. For more information, visit crfhealth.com. Cytel Inc., Cambridge, Mass., provides clinical-trial consulting services and specialized statistical software for the biopharmaceutical, medical-device, academic, and government research markets. For more information, visit cytel.com. Datafarm Inc., Marlborough, Mass., provides solutions for electronic document publishing and regulatory submission services for the life-sciences industry. For more information, visit datafarminc.com. DataLabs Inc., Irvine, Calif., develops Web-based applications for clinical development. For more information, visit datalabs.com. Decision Resources Inc., Waltham, Mass., is a world leader in 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. DMS Data Systems, Norwell, Mass., develops online databases, reports, and Website tracking systems focused on the pharmaceutical, biotechnology, drug-delivery, diagnostics, medical-device, equipment, and contract research and manufacturing industries. For more information, visit dmsdatasystems.com. DrugLogic, Reston, Va., develops analytical tools for managing risks related to drug-safety issues. For more information, visit druglogic.com. Medidata Solutions Worldwide Inc., New York, offers innovative process design, technology, and services to help life-sciences companies streamline clinical trials. For more information, please visit mdsol.com. Octagon Research Solutions Inc., Wayne, Pa., is a process-centric solutions provider, offering a suite of regulatory, clinical, process, and IT solutions to the life-sciences industry. For more information, visit octagonresearch.com. OmniComm Systems Inc., Ft. Lauderdale, Fla., provides electronic data capture (EDC) solutions for pharmaceutical, biotechnology, medical-device, and contract research organizations. For more information, visit omnicomm.com. Oracle Corp., Redwood Shores, Calif., is the world’s largest enterprise software company. For more information, visit oracle.com. The Pharmaceutical Institute, Raleigh, N.C., provides specialized knowledge for pharma and biotech professionals. For more information, visit pharmainstitute.com. Phase Forward Inc., Waltham, Mass., is a provider of integrated data-management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. Phoenix Data Systems Inc. (PDS), King of Prussia, Pa., is a global provider of clinical data management and full-service electronic data capture (EDC) solutions. For more information, visit pdsedc.com. PRA International, Reston, Va., is a global, clinical development organization. For more information, visit prainternational.com. SAS, Cary, N.C., provides business intelligence software and services. For more information, visit sas.com. Skyscape Inc., Marlborough, Mass., provides medical information, by specialty, for mobile devices. For more information, visit skyscape.com. Spotfire Inc., Somerville, Mass., develops analytics software. For more information, visit spotfire.com. Thomson Scientific, Philadelphia, a business of The Thomson Corp., offers information solutions to assist professionals at every stage of research and development. For more information, visit scientific.thomson.com.