Advanced smartphone app enables cost effective collection of Patient Reported Outcomes (PROs), helping trial sponsors conduct patient-centric research
PHT Corporation LogPad App™ System Collects Clinical Research Data from Apple and Android Smartphones
<0> For PHT CorporationBrenda Nashawaty, 617-688-3253 </0>
announced the general availability of the ™ System that collects compliant patient data using 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 post market and observational research, to massive patient populations.
PHT is the leading provider of innovative technology systems used to collect for clinical research. PHT developed the LogPad App utilizing the proven PHT technology used in more than 600+ clinical trials by leading pharmaceutical companies.
Over the past 10 years there has been a paradigm shift in the way regulators consider patient data. More attention is being paid to subjective experiences, symptoms, and side effects in the review and approval process of new drugs and medical devices, as evidenced by the FDA PRO Guidance for Industry finalized in 2009.
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. In 2012, analysts at the market research firm IDC predicted a 40% growth in smartphone sales.
Sheila Rocchio, MBA, Vice President of Marketing and Product Management at PHT, explained, “Ease of use, simplicity, regulatory compliance, and data integrity are critical to sponsors, clinicians, and patients. The LogPad App is a modern, attractive and easy-to-use option for clinical trial patients. It combines significant business and economic benefits with the proven LogPad System along with the numerous scientific benefits of collecting accurate and compliant patient experience data.
Patients download the LogPad App through a secure process that ensures attribution of data collected via the app to a unique trial participant. The LogPad App System is configured with a specific set of questions and schedule required by the study protocol. All eSource data collected is transferred to the PHT online portal where it can be viewed in real time by sites and study teams. StudyWorks provides an audit trail, data transfer, the online reporting tool, and dashboards which enable researchers to drill down into data.
Using the LogPad App System, sponsors and CROs reduce hardware costs and complexity by leveraging the hundreds of millions of existing Android and iOS smartphones and tablets. Trial sponsors have more choices regarding the devices which best meet the needs of a given trial and the hardware strategy to use, ranging from full provisioning to supplemental devices to leveraging all patient-owned devices.
The LogPad App has the ability to detect the necessary phone characteristics of display upon installation and to ensure psychometric consistency across the user experience of all trials. All data collected are secure and private. As part of the PHT electronic clinical outcome assessment (eCOA) System, the LogPad App System is CFR Part 11 compliant. For every clinical research program, the and review the study protocol and recommend the best eCOA System and/or questionnaires. The Teams consult with clients on all aspects of collecting COAs – incorporating scientific, regulatory, data management, and health outcome expertise.
Visitors to the PHT booth #2007 at the DIA Annual Meeting June 24-26 in Boston will have the opportunity to see the LogPad App in action. Learn more about the global migration to smartphones at . (Also at DIA, PHT will sponsor its second annual “You Spin, They Win!” game to raise funds for pediatric patients. Proceeds from this year’s fundraiser will benefit the Boston Children’s Hospital.)
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 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 600+ global trials resulting in 16+ regulatory approvals. PHT offers the regulatory, technological, and scientific expertise today’s market demands and patients deserve. Visit for more information on PHT. Follow PHT on , and .