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New Electronic and Web-based Applications, Sites, and Technologies E-Media June 2005 PharmaVOICE SAS Upgrades Scientific Discovery Solutions In response to the need for modernization in the drug-development process, SAS Institute Inc. has made significant upgrades and additions to its Scientific Discovery Solutions, which enable drug researchers to improve their productivity and maximize their investments in research and molecular technologies. In doing so, the solutions help pharmaceutical companies refine the process of delivering safe, effective drugs and treatments. “It can cost more than a billion dollars and the better part of a decade to bring a promising drug prospect into the hands of the patients who need it,” says Laurie Rose, director of health and life sciences strategy for SAS. “Pharmaceutical companies cannot afford to take that long and neither can the patients waiting for a medical breakthrough. SAS can provide the intelligence that scientific organizations need to identify, assess, and deliver valuable targets, promising drug leads, and appropriate biomarkers consistently, enabling organizations to deliver safer drugs and treatments more quickly.” SAS Scientific Discovery Solutions offers a comprehensive scientific analysis management system that improves the reliability and productivity of scientific research. The software helps researchers: identify failures and promising compounds earlier; proactively perform investigative and biomarker research; establish a centralized analysis resource; facilitate data preparation and analysis method customization; promote collaboration, data sharing, and a multidisciplinary view of research programs; and improve compliance features within discovery platforms. As part of its upgrade, SAS has added two new features to the existing Scientific Discovery Solutions suite, which previously included SAS Research Data Management, a centralized data repository and analysis management platform and SAS Microarray for microarray data analysis. SAS Genetic Marker enables researchers to effectively characterize genetic variability and evaluate its association with drug response and adverse events. SAS Proteomics provides statistically based analyses to identify protein biomarkers and establish their validity as key molecular indicators for biological conditions such as disease status or drug impact. In other company news, SAS has introduced SAS Drug Development 3.0, software that leverages the breakthrough capabilities of the SAS 9 Intelligence Platform to remove the obstacles in sharing data and applications across organizations and deliver the foresight and understanding required to succeed. The program allows users to access research and clinical-trials data scattered in silos across different departments on incompatible systems and then to integrate the data quickly, seamlessly, and in a cost-effective, regulatory-compliant manner. Available as a stand-alone or hosted solution, SAS Drug Development provides a centralized repository that allows life-sciences firms to analyze their clinical research for regulatory submission and explore new market opportunities, product line extensions, and safety issues, all within a controlled and secure collaborative framework. The new version provides a true production environment for the mass generation of clinical-trial analysis datasets and statistical summaries because it allows for the easy managment of collections of SAS programs used by different research teams and operational departments. Additionally, embedded versioning, audit trails, electronic signatures, and related controls provide full, irrefutable documentation of any data transformation and analysis activities. SAS can provide the intelligence that scientific organizations need to identify, assess, and deliver valuable targets, promising drug leads, and appropriate biomarkers consistently, enabling organizations to deliver safer drugs and treatments more quickly, says Laurie Rose, Director of Health and Life Sciences Strategy at SAS. Medidata Launches Partner Program for CROs In response to increasing demand from drug sponsors for electronic data capture (EDC) technology during clinical studies, Medidata Solutions Inc. has launched ASPire To Win, the company’s flagship partnership program for contract research organizations. ASPire To Win is a nonexclusive, application service provider (ASP) partnership that enables CROs to implement and use Medidata RAVE for conducting electronic clinical trials. The program provides the training, certification, and collaboration to equip CROs with the skills and capability to cost-effectively and professionally implement clinical trials using Medidata’s EDC and electronic clinical data management (eCDM) technology. Additionally, ASPire To Win shifts ASP service revenue related to EDC deployment away from the technology provider and to the CRO that builds, implements, and manages the EDC study. During the sales cycle, CROs will benefit from having EDC as part of their portfolio of services. On the operations side, ASPire to Win’s training and certification components prepare CROs to be knowledgeable and ready to implement EDC studies using Medidata RAVE. CROs are trained to build electronic CRFs according to the study protocol and certified to implement EDC studies with full regulatory compliance. Also, CROs achieve core competency in edit specifications, outputs, data mining, and EDC administration, so certified CROs are fully qualified to implement and manage electronic data capture using Medidata’s industry-leading RAVE platform. “Our CRO partners will provide services; and Medidata, an acknowledged leader in this field, will provide the intellectual property to support those services,” says Dennis Cunningham, senior VP of strategic alliances for Medidata. DSG Introduces CaseView Document Solutions Group Inc. (DSG) has introduced CaseView, a new technology to its EDC software offerings. CaseView allows anyone involved in the clinical-trial process — from the site to the sponsor — to upload, download, review, comment on, and draw on medical records and images. CaseView was created in response to suggestions from many of DSG’s clients, specifically in the oncology and ophthalmic sectors. The technology already is being used in four ongoing clinical trials and will be used for a large, groundbreaking study scheduled for the next several months. The CaseView feature brings EDC to the next level. Data, images, and the audit trail are combined into one integrated unit, accelerating the clinical-trial process and providing a unique clinical-data solution to the industry, says Tony Varano, President and CEO of DSG. Chiltern Launches New Website A major component of the new site is the careers section. Chiltern International Ltd.’s new Website, chiltern.com, offers an updated look while providing enhanced user-friendly navigation and search capabilities. The new site lists the company’s expanding range of services along with the latest company news, articles, and public-relations updates. A major component of the new site is the careers section, which enables candidates to search for positions worldwide, find out about training, and take advantage of the candidate referral bonus scheme. The section also features a job-alert service that allows interested candidates to input their qualifications to recieve automatic e-mail alerts when matching positions become available within the company. Chiltern’s Website also features a specialized volunteer/patient section, where users can learn about clinical trials being conducted by the company. WKHealth Releases New Version of Master drug Database MDDB is a comprehensive drug file available to healthcare professionals. Wolters Kluwer Health (WKHealth) has released the latest version of its Master Drug Database (MDDB) for healthcare industry professionals. MDDB is a comprehensive drug file available to healthcare professionals that provides pricing and extensive descriptive information for currently marketed drug products, including generic and branded prescription drugs, as well as over-the-counter and herbal products. The enhanced MDDB 2.5 version includes system updates and drug data content with a particular focus on patient safety. Additionally, daily content updates offer healthcare professionals important and timely information about medications, enhancing patient safety and improving overall care. Updates for previous versions of MDDB will continue to be available on a weekly, monthly, or quarterly basis. “Master Drug Database 2.5 provides a user-friendly interface for our customers and improves their access to the most up-to-date information on drugs and other safety issues through daily updates,” says Ken Killion, CEO of Wolters Kluwer Health’s Clinical Tools business unit. “This up-to-date information, in turn, enables healthcare professionals to more accurately assess available medications and enhance patient safety.” NOP World Health and Roper Public Affairs Introduce Pharma NewsFlow As the pharmaceutical industry increasingly appears in media headlines, corporate reputation and its influence on market outcomes are critical issues for drug manufacturers. In response to these concerns, NOP World Health and Roper Public Affairs have introduced Pharma NewsFlow, a research program that tracks the impact of news stories on the reputation of the pharmaceutical industry, specific companies, and therapeutic categories. Pharma NewsFlow enables the industry to better measure, manage, and address its growing public-relations challenges by providing a consistent tool for measuring the effects of press coverage on the attitudes and behaviors of key healthcare stakeholders, such as physicians, consumers, and managed-care pharmacy and medical directors. With an initial study, Pharma NewsFlow has established a benchmark of awareness, perceptions, and behaviors. Quarterly tracking offers an ongoing view of changing media and market dynamics. Early results from Pharma NewsFlow indicate that news stories are having an impact on healthcare stakeholders. Doctors and consumers are experiencing anxiety about the safety of prescription medications. According to Pharma NewsFlow, seven of 10 consumers and six of 10 physicians say they worry about the safety of prescription medications; and two-thirds of consumers claim they have reduced their reliance on prescription agents. In particular, the news media has had an impact on doctors’ and patients’ attitudes toward the chronic pain/arthritis category, a finding that reflects the heavy coverage of Vioxx and the safety questions around COX-2s. “The industry has been hit with a flood of negative news on everything from product withdrawals to pricing issues to importation,” says Keith Loehlein, senior VP of NOP World Health’s market assessment practice. “With Pharma NewsFlow, pharmaceutical companies can assess how their reputations are holding up during this turbulent period, and what effect the media is having on the health of their stocks, their brands, and even their therapeutic categories. They’ll have the insight to create the right messages and PR programs to support their success and protect their bottom lines — even during crises.” With Pharma NewsFlow, pharmaceutical companies can assess how their reputations are holding up during this turbulent period. They’ll have the insight to create the right messages and PR programs to support their success and protect their bottom lines — even during crises, says Keith Loehlein, Senior VP of NOP World Health’s Market Assessment Practice. PTS Launches Electronic Point of Care Recruiting solution In response to sponsor and site demands for new strategies to better enable and support site and patient recruitment, PharmaTech Solutions Inc. (PTS) has launched Electronic Point of Care (EPOC) Recruiting. The innovation is a direct result of listening, observing, and incorporating the site’s perspective into a recruitment model that mutually benefits the entire study team. From a clinical aspect, EPOC represents a higher qualified patient with increased retention. From a relationship aspect, EPOC increases the trusted doctor/patient and study team/site relationship. From a performance aspect, EPOC improves the entire clinical research life cycle’s effectiveness. The new PTS service EPOC has multiple components serving each unique entity of the clinical-research team. EPOC locates the patient in the investigator’s practice at the point of care or treatment facility. EPOC produces study subjects who have an established health provider trust relationship, are more qualified, more likely to enroll, and more likely to stay in a clinical trial. This new solution gives the sponsor more governance over the success of the clinical trial. The study site acquires more control over its enrollment process, resulting in an integrated study team with unified goals. EPOC leverages PTS’s core service competencies, or it may be used separately. EPOC supports both site and patient recruitment with full reporting capabilities and regulatory compliancy. It also presents an affordable response to rising clinical-research costs. PTS recognizes by enabling an effective study environment for the patient, the site becomes the anchor and a constant in the patient’s life, creating a sense of team or family for the study duration. The opportunity to convert a positive trial experience into a clinical-research success is the cornerstone of EPOC. The business driver for point-of- care recruiting mirrors our recruitment philosophy — to engage, recognize, and respect the personal commitment of each patient, site, and study team, says Sharen Godwin, VP of Strategic Development at PTS. With Pharma NewsFlow, pharmaceutical companies can assess how their reputations are holding up during this turbulent period. They’ll have the insight to create the right messages and PR programs to support their success and protect their bottom lines — even during crises, says Keith Loehlein, Senior VP of NOP World Health’s Market Assessment Practice. DigiScript and Provisio Team Up to Provide Improved Training and Recruitment Solutions DigiScript Inc. and Provisio Inc. have formed a strategic partnership to improve clinical trials and help pharmaceutical companies get their drugs to market as safely and quickly as possible. The partnership allows DigiScript to offer to its clients Provisio’s iTrials Candidate Pool Analysis Report and iTrials Patient Recruitment Services, along with its own clinical-trial training solution, TrialTrainerPLUS. “A clinical trial is a complex process that requires a deep understanding of all of the factors involved,” says Eddie Pearson, DigiScript’s CEO. “Both Provisio and DigiScript share that understanding, as well as a commitment to streamlining the clinical-trial process. By joining forces, we are bringing the very best in training and recruitment together and ultimately helping companies bring their compounds to market as swiftly as possible.” Provisio’s iTrials Candidate Pool Analysis Report is a customized analytical report that uses proprietary data to identify the number and locations of potential clinical-trial patients and investigators. Pharmaceutical companies use the report to refine and optimize their clinical-trial recruitment plans. The candidates are ranked according to the strength of their match to protocol and their proximity to a trial site. Provisio’s iTrials Recruitment Services then seek out and notify qualified candidates, managing their recruitment and trial enrollment. The iTrials Data Universe represents about 20 million patients (some 7% of the U.S. population) and 60,000 physicians from 2,000 healthcare organizations. “Our iTrials services help pharmaceutical companies by gathering, analyzing, and managing the data that goes into patient recruitment, which is instrumental in conducting a successful trial,” says Mike Hassell, CEO of Provisio. “iTrials is a terrific complement to DigiScript’s TrialTrainerPLUS. Each of these complementary solutions significantly improves the clinical-trial process, and together they are an even more powerful improvement on current practices.” DigiScript’s TrialTrainerPLUS is a flexible training solution that combines on-demand and live Web conferencing technology with targeted clinical-training services. TrialTrainerPLUS uses Web-based technology to enhance the clinical study training associated with investigator kick-off meetings and a variety of other training needs. Provisio’s iTrials Candidate Pool Analysis Report is a customized analytical report that uses proprietary data to identify the number and locations of potential clinical-trial patients and investigators. Pharmaceutical companies use the report to refine and optimize their clinical-trial recruitment plans. Siperian Launches CDI Hub Siperian Hub is quickly becoming the trusted IT foundation for companies that wish to deliver unified customer views across disparate data sources, says Darlene Mann, CEO of Siperian. Siperian Inc. has launched Siperian Hub, a comprehensive multiproduct customer data integration (CDI) platform that allows organizations to create more efficient and profitable customer relationships, reduce operations costs, and increase the accuracy of regulatory compliance. The company also has made available Siperian Hierarchy Manager (HM). As a CDI platform, Siperian Hub takes a hybrid approach that offers a neutral, template-driven data model that leverages a company’s pre-existing data tools and middleware. The platform is comprised of two products working in concert: the foundational Siperian Master Reference Manager (MRM) and the newly introduced Siperian HM. With these products, Siperian Hub delivers a trustworthy CDI platform, which builds a “system of record” for customer relationship and reference data that are strewn across multiple applications and data sources. Siperian HM delivers a reliable foundation for consolidating and managing unified views of customer relationships across multiple hierarchies from disparate applications and data sources. Follow up Chiltern International Ltd., Berkshire, United Kingdom, is a global contract research organization. For more information, visit chiltern.com. DigiScript Inc., Franklin, Tenn., is a provider of on-demand learning and training solutions, specializing in capturing live presentations and making them available on demand via the Internet and/or CD-ROM. For more information, visit digiscript.com. Document Solutions Group Inc., Oaks, Pa., is a privately held, information technology firm specializing in clinical-trial solutions for pharmaceutical, medical device, biotechnology, and contract research organizations. For more information, visit dsg-us.com. Medidata Solutions Inc., New York, develops electronic clinical data management solutions. For more information, visit mdsol.com. NOP World Health, East Hanover, N.J., supplies primary research to the global healthcare community, and is the health-focused arm of NOP World, a New York-based market research company. For more information, visit nopworld.com. PharmaTech Solutions Inc., Wilmington, N.C., is an established, full-service patient recruitment company providing innovative services enabling profitable clinical research. For more information, visit pharmatechsolutions.com. Provisio Inc., Nashville, Tenn., is a steward of partnered healthcare data and developer of proprietary information technologies to drive innovation in research and marketing for drugs and medical devices. For more information, visit provisio.com. Roper Public Affairs, New York, is a division of NOP World that provides strategic research supporting public relations, advocacy, and corporate communications. For more information, visit nopworld.com. SAS Institute Inc., Cary, N.C., provides next-generation business intelligence software and services. For more information, visit sas.com. Siperian Inc., San Mateo, Calif., develops solutions for comprehensive customer data integration and management. For more information, visit siperian.com. Wolters Kluwer Health (WKHealth), Philadelphia, provides information for professionals and students in medicine, nursing, allied health, pharmacy, and the pharmaceutical industry. For more information, visit wolterskluwer.com.