Tools of the Trade

Contributed by:

Denise Myshko

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

New Electronic and Web-based Applications, Sites, and Technologies

Featured Briefs:

Deloitte and Intermountain Healthcare Launch Comparative Effectiveness Tool Medidata Introduces Clinical Research Platform Cloud-Based Investigator Portal from Veeva Speeds Study ­Start-Up Sidebar: E-UPGRADES AND ENHANCEMENTS TrialCard Launches Solution To Stop Prescription Abandonment inVentiv Health Launches Tool To Help Recruitment And Retention BioClinica Introduces Trials Operational Visibility Tool SynteractHCR Launches Intelligent Clinical Development Platform Thomson Reuters Adds Solutions for Insights into Clinical Trials Accelrys Launches Laboratory Informatics System Virtify Launches Clinical Content Management Solution Trending Now: Life-sciences companies are challenged by a new paradigm to provide insights based on rigorous real-world evidence.

Deloitte and Intermountain Healthcare have launched OutcomesMiner, an analytics tool designed to give researchers, pharmaceutical, and medical device companies the data-driven insight needed to conduct comparative effectiveness research and bring new therapies to market more rapidly. Leveraging electronic medical records (EMR) data, OutcomesMiner helps users understand associated outcomes for treatments and filter for sub-populations using phenotypic characteristics and specific medical associations. The solution draws upon Intermountain’s repository of electronic health records (EHRs) in supporting analysis around patient and product outcomes under a double-blinded format designed to protect the privacy of personal health information. OutcomesMiner also enables users to conduct follow-on studies in developing further evidence to support comparative effectiveness research programs, new product planning activities, health economic, and outcomes research and observational insights that support safety analytics and commercial decision making. “The life-sciences and healthcare industry is entering a new era in which success is tied to demonstrating value for reimbursement with an increased focus on safety and clinical effectiveness,” says Brett Davis, general manager of Deloitte Health Informatics (DHI). Marc Probst, chief information officer of Intermountain, says users of OutcomesMiner will be able to form research communities that develop additional insights related to comparative effectiveness and evidence-based medicine. “OutcomesMiner can do more than provide insights in a one-off manner,” says Mr. Probst. “It can also be the catalyst that brings key players together in further exploring new approaches to healthcare based on data.” { For more information, visit deloitte.com or intermountainhealthcare.org. Medidata Introduces Clinical Research Platform Medidata Solutions has introduced the Medidata Clinical Cloud Study, which brings the benefits of Medidata’s cloud-based platform to single studies as an easy-to-acquire, ready-in-weeks option. The solution is a comprehensive platform for the unified planning, setup, and execution of a clinical trial, designed to be set up in a matter of weeks. Organizations of all sizes can use this single solution for trial activities including data capture and management, patient randomization, trial supply management, medical coding, patient reported outcomes, risk-based monitoring and business analytics. Medidata’s study design, budgeting and planning, site negotiation, operational trial management and safety capture solutions are also available as part of a Clinical Cloud Study. Medidata also announced its Medidata Patient Cloud, designed to enhance patients’ participation in clinical trials by allowing them to use their own personal mobile devices with iOS as an input device. A seamless application in the Medidata Clinical Cloud, it enables sponsors to save time and money typically associated with device management and provisioning, questionnaire development and implementation, and patient data management and integration. { For more information, visit mdsol.com. Cloud-Based Investigator Portal from Veeva Speeds Study ­ Start-Up Veeva Systems has launched Veeva Vault Investigator Portal. As a companion product to Vault eTMF, Vault Investigator Portal enables fast collection, sharing and tracking of all investigator content from a single platform. Veeva has specifically designed its new Investigator Portal to speed study start-up by simplifying the overall trial document management process and providing bi-directional, direct access to the eTMF. “The back and forth between investigators and the CRO or sponsor is causing huge delays in study start-up,” says Michael Burton, director of clinical product strategy at Veeva. “Most of these documents are still exchanged as paper, which is slow and adds expense. Sponsors and CROs must find ways to improve the efficiency while protecting the increasingly important site relationship.” Veeva’s Vault Investigator Portal helps streamline trials and increase efficiency with features that lessen the workload for sponsors and investigators, including: a single source for sponsors, CROs, and investigator sites to submit and access documents; direct placement of site documents into the eTMF; and two-way channel for exchanging documents, including safety alerts and site training videos. { For more information, visit veeva.com. TrialCard Launches Solution To Stop Prescription Abandonment TrialCard has launched RxSaver, the solution to stop abandonment of prescriptions. RxSaver is a network of pharmacies dedicated to helping a patient start and stay on their medication as directed by their prescriber. “Pharmacists are the last healthcare provider to interact with a patient about their medication. Pharmacists are the most trusted healthcare provider about a patient’s medication,” says Mark Bouck, president of TrialCard. “RxSaver empowers the pharmacist. RxSaver is an innovative solution to stop the abandonment of a clinically valuable prescription.” Prescription abandonment is a key societal healthcare issue. Patients are not picking up the medications and therapy that were prescribed for them. Cost of medications is a factor in prescription abandonment. A recent study in the Annals of Internal Medicine showed that “prescriptions with a copayment of greater than $50 were 4.68 times more likely to be abandoned than prescriptions” without any copayment. { For more information, visit trialcard.com. inVentiv Health Launches Tool To Help Recruitment And Retention inVentiv Health has launched a new solution to tackle the problem of identifying, recruiting, and retaining patients and clinical trial investigators. inVentiv Clinical Trial Recruitment Solutions (iCTRS) combines a large array of physician and patient data sources with aggregation, algorithmic and online engagement technologies that identify potential clinical trial patients and investigators. Data sources include claims information from more than 900,000 physicians and 115,000 investigators, and prescription details from more than 100 million U.S. patients. Recently, iCTRS has also formed partnerships to enhance its ability to reach doctors and patients and expedite trial enrollment, including with Medikly and PatientsLikeMe. Medikly’s technology, originally developed for drug marketing, helps pharma companies identify and engage with physicians based on their online behavior. PatientsLikeMe, an online community, provides insights from 200,000 patient members who share information and experiences on more than 1,500 diseases. “The magnitude of the challenge prompted us to identify the resources within our organization that could help solve a problem that all sponsors face,” says Paul Meister, CEO of inVentiv Health. “We pulled apart the problem, focused our diverse capabilities on solving each part. and the result is a major step forward in recruitment and retention.” { For more information, visit inventivhealth.com. BioClinica Introduces Trials Operational Visibility Tool BioClinica has introduced StudyView, a clinical trials portal and reporting hub that increases clinical trials operational visibility. Study­View provides one convenient tool to access multiple e-clinical applications, as well as analyze and report data across studies Data visualization tools bring analytics to life with real-time data, informing operational decisions about clinical studies. StudyView is fully integrated with BioClinica’s product suite and is 21 CFR Part 11 compliant. “Achieving real-time operational visibility of clinical studies data can be difficult, especially when multiple systems are involved,” says Peter Benton, BioClinica’s president of e-Clinical Solutions. “This is the kind of cross-system operational metrics visibility that is a necessary cornerstone of any risk-based monitoring plan.” StudyView leverages a suite of Microsoft business intelligence technologies such as Power View to create interactive dashboards and SQL server reporting services. { For more information, visit bioclinica.com. SynteractHCR Launches Intelligent Clinical Development Platform SynteractHCR has unveiled Intelligent Clinical Development platform (ICD+), a platform that allows sponsors to get to decision points faster, while providing a uniform approach to trials globally to promote consistent standards and high quality. “As we strive to streamline clinical trials and deliver better therapies in healthcare, we are confident that with ICD+, we offer a great solution to our clients,” says SynteractHCR CEO Wendel Barr. “We collaborate with our clients to meet their project objectives, deliver timely results, and provide high quality work that exceeds their expectations, and ICD+ is the approach we use to guide the process.” { For more information, visit synteracthcr.com. Thomson Reuters Adds Solutions for Insights into Clinical Trials The Intellectual Property & Science business of Thomson Reuters released two clinical trial intelligence software solutions: Cortellis Clinical Trials Intelligence and Cortellis Site Performance Advisor. Clinical Trials Intelligence allow users to access and search information on more than 130,000 U.S. and global trials for biologics, diagnostics, biomarkers, medical devices and drugs targeting rare diseases. It offers full integration with Thomson Reuters industry-leading drug pipeline content and is available via the Web portal or an application programming interface (API). Cortellis Clinical Trials Intelligence provides more than a dozen dynamic visualizations that support fact-based decision making and enhance competitive positioning. It also includes a trial timeline viewer that provides an up-to-date, longitudinal view of the trial start dates, insights on trial duration trends and expected, actual or projected end dates for a given indication, company or individual drug. “Cortellis Clinical Trials Intelligence is a powerful resource, enabling industry professionals to make informed decisions that direct their clinical strategies,” says Wendy Hamilton, senior VP, Thomson Reuters Life Sciences. “It locates patient trials with specific efficacy endpoints or efficacy biomarkers, offers dynamic analytics and delivers current, detailed information on trials.” Cortellis Site Performance Advisor is an integrated solution comprising the fastest recruiting sites, ideal countries for recruitment, and countries that have applicable, relevant patient populations. { For more information, visit thomsonreuters.com. Accelrys Launches Laboratory Informatics System Accelrys has introduced Accelrys Experiment Knowledge Base, a laboratory informatics system that enables organizations to transform mass amounts of scientific data into knowledge essential for faster, more efficient new product innovation. Designed specifically for research and development, EKB offers scientists for the first time the ability to search and mine experimentation data from almost any source. The system also provides integration and interoperability with existing lab equipment and applications as well as features for improving experimentation management and collaboration. “With a specific focus on R&D, EKB complements our downstream laboratory informatics offerings, including the newly released Accelrys LIMS, and exemplifies Accelrys’ continued commitment to providing first-in-class products that streamline the scientific innovation lifecycle across the lab-to-commercialization value chain and accelerate innovative new product development,” says Leif Pedersen, senior VP of marketing, product management and corporate development, Accelrys. { For more information, visit accelrys.com. Virtify Launches Clinical Content Management Solution Virtify has released Virtify SCM, a software platform for creation, reuse, and tracking of clinical and regulatory content. Virtify SCM (Structured Content Management) takes an asset management approach to improve collaboration and enables the automation of documents used throughout the drug product life cycle, from preclinical through product registration to commercialization. Virtify SCM is a secure, collaborative, Web-based environment for managing regulated content through linked data components that automate and track all information known about a product, trial or objective at all stages of the development. Virtify SCM uses business rules-based templates and builds a library of re-useable content. It leverages organizational data across all operations, including R&D, submissions, labeling and marketing. { For more information, visit virtify.com. IMS Health’s Clinical Trials Optimization ­Solution group has released GrantPlan 3.5, the latest version of the company’s clinical trials cost benchmarking product. The latest version leverages IMS Health data, supporting complexity calculations for study budgets based on data mining of tens of thousands of grants, pulling out which indications, patients, and procedure types increase costs beyond the expected range. The new version also adds shortcuts to the most frequently used procedures for a protocol’s therapeutic area and also tracks trends in personnel and site startup costs. { For more information, visit imshealth.com. PHT has released LOgPad App System for the latest Apple and Android smartphones, including patient’s own devices. The LogPad App gives sponsors and CROs the flexibility to deploy Phase II, III, and IV clinical studies along with postmarket and observational research, to massive patient populations. The LogPad App enables sponsors and CROs to leverage the world’s migration to smartphones and take advantage of the latest technology with which consumers are comfortable and familiar. { For more information, visit phtcorp.com. Quintiles has added new functionality that improves laboratory management for investigator sites, delivered by Quintiles Infosario technology platform. Infosario combines data, processes, and Quintiles’ therapeutic expertise to enable faster, better-informed decisions across the drug development lifecycle. With Infosario, investigators and site personnel now have the ability to order tests, track samples and view results within one secure, online portal. { For more information, visit quintiles.com RxVantage has released RxVantage iPhone application. The new tool is an added feature at no cost to premium reps who already use the RxVantage platform to communicate with medical practices through the use of its scheduling application and suite of software tools. The RxVantage iPhone application is optimized for iPhone 5 and compatible with any device running IOS 6. Native mobile apps for other devices, including Android and Windows, are currently in development. { For more information, visit RxVantage.com. Veeva CRM adds new survey functionality to deepen customer understanding and drive more relevant interactions. The new built-in survey capability in Veeva CRM enables organisations to continuously capture customer feedback directly from any channel. The new surveys and assessments functionality in Veeva CRM allows business users to quickly develop surveys and execute them either online or by field representatives during their interaction with the healthcare provider. Coinciding with its latest release, Veeva also announced the general availability of Veeva CRM Approved Email, an end-to-end solution to enable regulatory compliant email communication between sales reps and healthcare providers. { For more information, visit veeva.com.

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