The LogPad App™ System – The Best ePRO App

Sponsors and CROs get the flexibility to deploy a clinical program using a patient's own smartphones.

PHT is the leading provider of innovative technology systems used to collect patient-driven eData for clinical research. PHT developed the LogPad App utilizing the proven PHT eCOA System 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.

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.

Secure, Encrypted 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 StudyWorks^® online portal where it can be viewed in real time by sites and study teams. StudyWorks provides an audit trail, data transfer, the SmartReports™ online reporting tool, and dashboards which enable researchers to drill down into data.

Reduced Hardware Costs and Logistics Issues – 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.

Scientific and Regulatory Compliant – 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 PHT Consulting Services and Science Teams 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.