|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.
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, 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. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
Feb. 27, 2017 06:45 AM EST Reads: 1,737
SYS-CON Events announced today that CA Technologies has been named “Platinum 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, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Feb. 27, 2017 06:43 AM EST
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" ...
Feb. 27, 2017 06:00 AM EST Reads: 6,145
After more than five years of DevOps, definitions are evolving, boundaries are expanding, ‘unicorns’ are no longer rare, enterprises are on board, and pundits are moving on. Can we now look at an evolution of DevOps? Should we? Is the foundation of DevOps ‘done’, or is there still too much left to do? What is mature, and what is still missing? What does the next 5 years of DevOps look like? In this Power Panel at DevOps Summit, moderated by DevOps Summit Conference Chair Andi Mann, panelists l...
Feb. 27, 2017 05:00 AM EST Reads: 7,406
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 27, 2017 04:30 AM EST Reads: 2,233
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/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.
Feb. 27, 2017 04:30 AM EST Reads: 4,297
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Feb. 27, 2017 04:00 AM EST Reads: 7,349
910Telecom exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. 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 exchanges.
Feb. 27, 2017 03:30 AM EST Reads: 2,186
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Feb. 27, 2017 03:00 AM EST Reads: 2,486
Hardware virtualization and cloud computing allowed us to increase resource utilization and increase our flexibility to respond to business demand. Docker Containers are the next quantum leap - Are they?! Databases always represented an additional set of challenges unique to running workloads requiring a maximum of I/O, network, CPU resources combined with data locality.
Feb. 27, 2017 03:00 AM EST Reads: 2,290
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Feb. 27, 2017 02:00 AM EST Reads: 7,548
Zerto exhibited at SYS-CON's 18th International Cloud Expo®, which took place at the Javits Center in New York City, NY, in June 2016. Zerto is committed to keeping enterprise and cloud IT running 24/7 by providing innovative, simple, reliable and scalable business continuity software solutions. Through the Zerto Cloud Continuity Platform™, organizations can seamlessly move and protect virtualized workloads between public, private and hybrid clouds. The company’s flagship product, Zerto Virtual...
Feb. 27, 2017 01:30 AM EST Reads: 1,955
Some people worry that OpenStack is more flash then substance; however, for many customers this could not be farther from the truth. No other technology equalizes the playing field between vendors while giving your internal teams better access than ever to infrastructure when they need it. In his session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will talk through some real-world OpenStack deployments and look into the ways this can benefit customers of all sizes....
Feb. 27, 2017 01:15 AM EST Reads: 1,717
In recent years, containers have taken the world by storm. Companies of all sizes and industries have realized the massive benefits of containers, such as unprecedented mobility, higher hardware utilization, and increased flexibility and agility; however, many containers today are non-persistent. Containers without persistence miss out on many benefits, and in many cases simply pass the responsibility of persistence onto other infrastructure, adding additional complexity.
Feb. 27, 2017 01:15 AM EST Reads: 1,684
As businesses adopt functionalities in cloud computing, it’s imperative that IT operations consistently ensure cloud systems work correctly – all of the time, and to their best capabilities. In his session at @BigDataExpo, Bernd Harzog, CEO and founder of OpsDataStore, will present an industry answer to the common question, “Are you running IT operations as efficiently and as cost effectively as you need to?” He will expound on the industry issues he frequently came up against as an analyst, and...
Feb. 27, 2017 01:00 AM EST Reads: 2,154