Tools of the Trade

Contributed by:

Carolyn Gretton

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

Sermo Sponsorship Harnesses Power of Physician-Peer Communications Trend: With social media making it easier than ever for physicians to connect and discuss new ­treatment developments, life-sciences ­companies are seeking innovative and appropriate ways to ­become part of these conversations. Sermo Sponsorship is a portfolio of offerings from the online physician network Sermo designed to provide new opportunities for life-sciences companies to engage physicians and educate them on new products and programs. Available on Web and mobile platforms, Sermo Sponsorship can be employed by companies to drive awareness of drugs or devices or to communicate new clinical and indication data. The Sermo network facilitates discussion and peer influence, creating a multiplier effect that reinforces key takeaways and increases the number of physicians exposed to the new information. Jon Michaeli, VP of marketing at Sermo, notes that research shows peer influence has the greatest impact on physicians’ clinical decisions. “The Sermo Sponsorship product helped drive awareness of a major new oncology drug during the period immediately following the American Society of Clinical Oncology (ASCO) annual meeting,” says Rich Westelman, senior VP of sales at Sermo. Sermo Sponsorship was designed to maximize the use of already approved materials, making rollout of educational materials and resources for physicians simple, quick, and cost-effective. The offerings also allow targeting by specialty, ensuring relevance and maximizing physician interest and engagement. In addition to Sermo’s existing Client Post product, which allows companies to spark discussion directly with physicians, the sponsorship offerings include dedicated brand pages on Sermo with useful educational tools and resources, and mobile messaging that instantly alerts and informs specialists about brand, product, and company developments. { For more information, visit sermo.com. E-UPGRADES AND ENHANCEMENTS eClinical Solutions has released version 4.0 of its eGrex clinical data repository (CDR) solution, a cost-effective software platform enabling easy access to and analysis of clinical trial data. Key features of the release include a repository that manages and utilizes metadata from the entire clinical data life cycle and a running reviewable activity log that tracks data coming in and out of the system by user with timestamps and audit trails. { For more information, visit eclinicalsolutions.com. IntraLinks has introduced the IntraLinks Secure Mobile Solution app for the iPad and iPhone that gives professionals access to real-time IntraLinks intelligence from their mobile devices. Combining IntraLinks’ secure cloud computing services with the freedom and functionality of the iPad and iPhone enables users to realize the productivity of features such as centralized access to documents and the ability to send alerts, change permissions, and view reports when working remotely or in transit. { For more information, visit intralinks.com. PHT Corp. has launched an enhanced version of SmartReports within its StudyWorks online clinical patient data reporting system. The SmartReports tool has an intuitive interface that enables project managers, monitors, and sites to sort by report headers, drill-down within subject and site data, and view translations of reports into the user’s native language. Enhancements to the tool include study-wide and program-wide dashboards, trial or drug branding within data reports, and customized layout and print options. { For more information, visit phtcorp.com. Sparta Systems has made available two tailored offerings for its TrackWise enterprise quality management system. The Preclinical GLP (Good Laboratory Practice) and Clinical GCP (Good Clinical Practice) Auditing Solutions automate critical workflow processes by managing all steps in the preclinical and clinical audit life cycles, including: audit scheduling, preparation, audit execution, report approval, report issuance, response, and corrective action tracking. { For more information, visit ­spartasystems.com. Imaging CRO WorldCare Clinical (WCC) has released a new version of its WorldPRO image management platform, a comprehensive system that collects, integrates, and presents data to multiple reviewers in a regulatory-compliant, efficient, and effective manner. The latest version of WorldPRO allows multiple clinicians to access and evaluate data in preparation of an endpoint assessment committee (EAC) review. { For more information, visit wcclinical.com. I-Monitor Eliminates Data-Entry Redundancies PharmaVigilant’s I-Monitor solution enhances the sponsor footprint at the clinical site, significantly improving speed, accuracy, and regulatory compliance while still reducing sponsor costs. Through services offered by I-Monitor, the sites fill out source worksheets and transmit them to PharmaVigilant, where data specialists then enter the data into the EDC system, eliminating data entry at the site. This function eliminates the need for double data entry, saving time and money while ensuring clean data. This also enables on-site monitors to reduce the number of site visits, ensuring a cost-effective and less-disruptive site approach to verifying data. James DeSanti, founder and CEO of PharmaVigilant, says by reducing site involvement in the data entry and query resolution process, study coordinators have more time to address enrollment and patient-related activities. “I-Monitor leaves the time-consuming data entry/monitoring processes to remote specialists and a reduced number of onsite monitors and streamlines the process to less than five days to enter, review, and address any data entry issues,” Mr. DeSanti adds. { For more information, visit ­pharmavigilant.com. In other technology news… Janssen Pharmaceuticals has added more resources and tools to its PrescribeResponsibly.com online program designed to support appropriate and responsible treatment of pain. Clinical materials newly added to the website include a variety of pain and risk assessments intended to help physicians evaluate pain, manage adverse events, identify aberrant drug-related behaviors, monitor long-term therapy, facilitate patient education and communication, and document treatment progress when using opioid therapies. The site also features general education content authored by experts related to safe and responsible opioid prescribing and pain management. “Pain medications play an important role in the treatment of pain when used correctly,” observes Paul Chang, M.D., VP of medical affairs at Janssen. “We want to make sure we equip physicians with the appropriate resources and tools to help them safely and effectively use opioids in their practice so that patients are neither undertreated nor unnecessarily exposed to risk.” { For more information, visit prescriberesponsibly.com. CRF Health has unveiled an open ePRO integration interface that enables sponsors and CROs to integrate their own e-clinical systems with CRF Health’s TrialMax ePRO platform to provide data collected from patients in real time to all study stakeholders. The TrialMax Synapse open interface integrates ePRO data collected with CRF Health’s TrialMax platform to other e-clinical systems in real time using the CDISC ODM standard. The TrialMax Synapse open interface offers efficient tools for setting up and maintaining integration in individual clinical studies according to users’ specific needs. “Real-time integration of study data is the future of e-clinical,” says Pekka Keskiivari, chief technology officer of CRF Health. “By using good technology along with relying on standards, we can make the deployment very straightforward.” { For more information, visit crfhealth.com. iWorx Systems’ IX-ECG12 12-Lead ECG Recorder is a compact, lightweight, PC-based ECG recorder that enables highly detailed analysis of the anterior, lateral, and inferior regions of the heart for accurate and reliable ECG analysis of resting and exercising humans or animals. The IX- ECG12 connects to and is powered by a USB port on any Windows or Macintosh computer, and data is recorded and analyzed with iWorx’s advanced LabScribe2 ECG Software Module. The module automates the analysis of ECG data and provides a comprehensive set of preconfigured routines to simplify data interpretation and analysis. { For more information, visit iworx.com.

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