|By Business Wire||
|December 2, 2013 08:01 AM EST||
The PHT Corporation LogPad® System was used by Gilead Sciences, Inc. (NASDAQ: GILD) on the Phase 4 TERISA trial which measured the antianginal effect of Ranolazine in T2DM patients in the therapeutic areas of cardiology and endocrinology. PHT Corporation is the leading provider of technologies used to collect patient-driven eData for clinical research. The LogPad System, which has been used on more than 650 clinical trials, eliminates data quality concerns created by a paper diary.
Eight million people in the U.S. alone suffer from chronic stable angina, yet many patients remain undertreated. Gilead Sciences successfully completed their TERISA trial and collected the needed FDA regulatory-compliant patient-reported outcomes (PROs) primary endpoint data with the LogPad System. The LogPad System was customized to fit the trial’s needs to provide accurate and verified data.
- A clinical trial to support Gilead Sciences’ work to benefit angina sufferers
- Confirmation that eDiaries are an effective and economical way to capture angina endpoints such as episodes and dyspnea in angina patients vs. treadmill or paper diaries
- Evidence that global patients, including elderly patients, demonstrate high and stable compliance with diary completion at 98%
Download the complete case study here: http://bit.ly/PHTCaseStudies
Patrick Yue MD, Director of Cardiovascular Clinical Research at Gilead Sciences, explained, “Gilead Sciences chose the PHT LogPad System because it eliminated poor quality paper diary data and logistics concerns. Observing the patient-reported number of angina episodes and sublingual nitroglycerin use over a period of time follows the increasing regulatory emphasis on PROs. It also provides a significantly more cost-effective trial design. With the PHT LogPad System, an ePRO diary could be designed and customized to fit the exact TERISA trial needs.”
Watch Dr. Yue talk about his experience working with PHT on the TERISA trial: http://bit.ly/GileadVideo
The LogPad System was advantageous vs. other ePRO providers because PHT has significant experience in the angina indication, having run previous global Phase 3 angina studies in similar regions around the world. Additionally, PHT enabled Gilead to integrate data from the LogPad System directly into an Electronic Data Capture System, Medidata Rave, to streamline data management. PHT’s international logistics expertise allowed for seamless device delivery, trial integration and translation into local languages in 14 countries including Russia.
PHT President and CEO Philip Lee said, “PHT was proud to work with Gilead on this important study. It is another proof point that PHT eCOA Systems are an extremely effective method for collecting compliant PROs that enable sponsors to speed the delivery of new drugs and treatments to patients who need them.”
To hear other case studies, innovations and best practices about PROs and eCOA Strategy and Systems, register for the 2014 PRO & eCOA Congress at bit.ly/16EYVSg. PHT invites all Congress alumni to join the exclusive PRO & eCOA Congress LinkedIn Community to exchange information, ideas and experiences throughout the year.
About Gilead Sciences, Inc.
Gilead Sciences (NASDAQ: GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
About PHT Corporation
PHT Corporation helps pharmaceutical companies and CROs conduct clinical trial programs with greater confidence, ease and accuracy. Proven PHT electronic clinical outcome assessment (eCOA) Systems collect patient-driven eData via smartphones, tablets and the web. This data, available via StudyWorks™ online reporting portal, provides sponsors and clinicians with a real time window into how patients feel and function. PHT has helped trial sponsors collect patient-driven eData in 650+ global trials resulting in 16+ regulatory approvals. PHT Clinical Science and Consulting offers the scientific, regulatory, and technological expertise today’s eCOA market demands and patients deserve. Visit phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Twitter, Google+ and YouTube.
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 28, 2016 08:30 PM EDT Reads: 1,806
Deploying applications in hybrid cloud environments is hard work. Your team spends most of the time maintaining your infrastructure, configuring dev/test and production environments, and deploying applications across environments – which can be both time consuming and error prone. But what if you could automate provisioning and deployment to deliver error free environments faster? What could you do with your free time?
Aug. 28, 2016 08:15 PM EDT Reads: 1,927
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Aug. 28, 2016 07:30 PM EDT Reads: 675
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 28, 2016 06:30 PM EDT Reads: 1,601
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 28, 2016 06:00 PM EDT Reads: 1,913
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Aug. 28, 2016 05:30 PM EDT Reads: 729
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 28, 2016 03:15 PM EDT Reads: 3,486
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Aug. 28, 2016 03:00 PM EDT Reads: 740
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 28, 2016 01:45 PM EDT Reads: 3,651
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 28, 2016 01:00 PM EDT Reads: 2,418
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 28, 2016 12:15 PM EDT Reads: 845
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 28, 2016 11:45 AM EDT Reads: 684
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Aug. 28, 2016 11:30 AM EDT Reads: 1,955
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 28, 2016 11:00 AM EDT Reads: 701
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 28, 2016 11:00 AM EDT Reads: 3,124