Welcome!

News Feed Item

Gilead Sciences, Inc. Uses the PHT Corporation LogPad® System for 1st Antianginal Drug to Treat Type 2 Diabetes

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.

The result:

  • 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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
IBM helps FinTechs and financial services companies build and monetize cognitive-enabled financial services apps quickly and at scale. Hosted on IBM Bluemix, IBM’s platform builds in customer insights, regulatory compliance analytics and security to help reduce development time and testing. In his session at 20th Cloud Expo, Tom Eck, Industry Platforms CTO at IBM Cloud, will discuss how these tools simplify the time-consuming tasks of selection, mapping and data integration, allowing developers ...
In order to meet the rapidly changing demands of today’s customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
As enterprise cloud becomes the norm, businesses and government programs must address compounded regulatory compliance related to data privacy and information protection. The most recent, Controlled Unclassified Information and the EU’s GDPR have board level implications and companies still struggle with demonstrating due diligence. Developers and DevOps leaders, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by in...
SYS-CON Events announced today that EARP Integration will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. EARP Integration is a passionate software house. Since its inception in 2009 the company successfully delivers smart solutions for cities and factories that start their digital transformation. EARP provides bespoke solutions like, for example, advanced enterprise portals, business intelligence systems an...
SYS-CON Events announced today that Outscale, a global pure play Infrastructure as a Service provider and strategic partner of Dassault Systèmes, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2010, Outscale simplifies infrastructure complexities and boosts the business agility of its customers. Outscale delivers a secure, reliable and industrial strength solution for its customers, which in...
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs oft...
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
The 21st International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 21st International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo Silicon Valley Call for Papers is now open.
SYS-CON Events announced today that Interoute has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Interoute is the owner operator of Europe's largest network and a global cloud services platform, which encompasses over 70,000 km of lit fiber, 15 data centers, 17 virtual data centers and 33 colocation centers, with connections to 195 additional partner data centers. Our full-service Unifie...
For financial firms, the cloud is going to increasingly become a crucial part of dealing with customers over the next five years and beyond, particularly with the growing use and acceptance of virtual currencies. There are new data storage paradigms on the horizon that will deliver secure solutions for storing and moving sensitive financial data around the world without touching terrestrial networks. In his session at 20th Cloud Expo, Cliff Beek, President of Cloud Constellation Corporation, w...
SYS-CON Events announced today that Twistlock, the leading provider of cloud container security solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Twistlock is the industry's first enterprise security suite for container security. Twistlock's technology addresses risks on the host and within the application of the container, enabling enterprises to consistently enforce security policies, monitor...