Industry Provider Profiles
Company Type Services
PHT Corporation helps pharmaceutical companies and CROs conduct clinical studies with greater confidence, ease, and accuracy. PHT Electronic Clinical Outcome Assessment (eCOA) Systems enable clients to gain real-time insights through collecting and measuring how patients feel and function at the point of experience. This technology and the service PHT provides help clients speed new therapies to market that ultimately improve patient quality of life around the world. From 600+ global trial experiences, including 16+ regulatory approvals, PHT offers the regulatory, technology, and scientific expertise today’s market demands and patients deserve.
PHT is passionate about Patient-Driven eData and its influence on improving quality of life.Patient-Driven eData encompasses all eCOA including patient reported (PRO), clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO).
PHT is the perpetual innovator for delivering new technology for clinical researchers to provide better research and develop new therapies, treat disease, and improve patient quality of life.
Dr. Stephen Raymond founded PHT and the Electronic Patient Reported Outcome (ePRO) industry to offer pharmaceutical companies clinical trial technology and patient-driven eData systems to collect high quality data directly from patients and clinicians.
PHT experience spans exploratory to post-market programs and includes multiple therapies. All of the top 10 pharmaceutical companies, 18 of the top 20, and more than 115 additional pharmaceutical companies in 75 countries choose PHT eCOA Systems. From over 600 clinical research programs, clients have submitted at least 18 NDA submissions that resulted in 16 approvals and 14 PRO label claims as of December 2012.
PHT is invariably dedicated to building confidence behind patient data. Be confident at every phase of your clinical trial program.
For more information on PRO and ePRO innovations, review the interactive content and demonstrations at phtcorp.com. Follow #PHT_ePRO on Twitter.
The flexible PHT eCOA system collects regulatory compliant patient-driven eData via smartphones, tablets and the web.
All data is available for review in real-time by study stakeholders. Patient-driven eData encompasses all electronic clinical outcome assessments (eCOA) including patient reported (PRO), clinician reported (ClinRO), and observer or caregiver reported outcomes (ObsRO).
The PHT eCOA System provides data that enable better outcomes that speed new therapies to market by giving sponsors and sites real-time insights into how patients feel and function. PHT supply chain ownership and global experience in 600+ eCOA trials enable CROs, pharmaceutical and medical device companies to leverage a proven eCOA system.
The LogPad® System – The First and Leading eDiary
The LogPad® System collects study data from a patient anywhere. The LogPad App™ runs on a patient’s own smartphone to collect study data from the patient anywhere.
The PHT LogPad System is the most widely used electronic patient reported outcome (ePRO) System in the world. Ease of use, simplicity, regulatory compliance, and data integrity are critical to sponsors, clinicians, and patients around the globe. PHT delivers the patient-driven eData you need for your unique trial. The PHT team thoroughly reviews your protocol and solves problems by implementing the optimal ePRO/eCOA system for your trial from FPI to LPO.
The popular family of mobile PHT ePRO data collection devices includes the LogPad LW, a large-screened ruggedized device designed for commercial use and longevity containing an embedded 3G radio for simple and rapid data transmissions.
Unlike trendy smartphones and other consumer mobile data collection devices that are designed for a short shelf-life and rapid replacement, the PHT LogPad serves long-term clinical trials and studies with new inventory available through 2015 with PHT support well beyond that date.
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.
The LogPad App™ System 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 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.
Capture unfiltered data and end the cycle of incomplete, unreliable patient questionnaire data. The SitePad System delivers unbiased PROs directly from patients at the site.
The SitePad is a mobile eCOA data collection tablet used to capture multiple patient-reported and clinician assessments at the site. The SitePad System raises the quality of site-based real-time data capture for ePRO/eCOA patients and study coordinators. PHT worked with study coordinators to design the SitePad System’s mobile eSource device with a large touch screen and user-friendly interface. Each device supports 500 patients.
For study design the SitePad System uses protocol-specific branching, logical automatic calculations, and reliable high-speed data transmissions. You can collect:
- Clinical Outcome Assessments (COA)
- Clinician Reported Outcomes (ClinRO)
- Patient Reported Outcomes (PRO)
- Site surveys and questionnaires (ObsRO)
Sponsors are getting better data with smaller, faster trials by collecting site-based data with the PHTSitePad. Since 2003, PHT has efficiently captured end-point data at physician offices and clinics.
The SitePad is ideal for collecting high quality PROs and ClinROs at sites. Finger-touch data entry on the 10” screen is designed to accommodate lengthy questionnaires and questions with lots of text required of trials for Alzheimer’s, Arthritis, Hep C, Oncology and Psychiatry.
The NetPRO™ System – Bringing ePRO to Every Internet User Worldwide
NetPRO is abrowser-based method for PRO data capture that sends data to a central server and database for web review by site and sponsor.
Regulatory agencies encourage sponsors to collect data directly from patients. Clinical professionals are eager to leverage the Internet to collect patient-driven eData for large clinical studies and post-market surveys.
ePRO on the web helps sponsors collect faster, more ef?cient data to help the clinical research industry develop new therapies, treat disease and improve quality of life.
NetPRO is ideally suited for late phase research and is cost-effective for large studies. By using a web browser to host the diary or questionnaire, NetPRO can collect ePRO, eCOA, and post-marketing safety data from large global populations. PRO data collected with NetPRO can support a labeling claim.
NetPRO includes the PHT secure backend server and StudyWorks™ for easy data management by sites and sponsors.
NetPRO provides more options to sponsors for collecting ePRO. NetPRO is 21 CFR Part 11 compliant and a member of the same PHT ePRO system sponsors have used on over 600 trials.
PHT eSense medical devices integrate with the PHT eCOA System to collect and evaluate physiological patient measurements and PROs for Diabetes and Respiratory clinical research.
Integrated Peak Expiratory Flow (PEF) Meters and Glucometers collect precise objective physiological data and subjective patient reported outcomes. eSense uses wireless Bluetooth® data transfers which avoid transcription errors.eSense delivers high-quality, attributable 21 CFR Part 11 compliant-data directly to each patient diary and to the PHT StudyWorks® secure online reporting portal.
StudyWorks is the secure online portal of all eCOA data collected by any PHT modality, providing easy access to real-time data and standardized SmartReports™ on trial participant compliance, enrollment and safety.
SmartReports Mobile™ is a smartphone app that enables monitors to check patient compliance anytime and anywhere; identify patients who are outside compliance variance; and use one tap on the screen to call the site in order to expedite compliance issues.
Using standard and custom data summaries and reports, StudyWorks enables site personnel to manage compliance and enrollment while helping sponsors stay informed about their trials to the deepest level of detail at all times. The information loads quickly, even with growing study complexity and size.
Without a StudyWorks implementation customers receive weekly updates, usually through a telephone conference with their Project Manager. If a customer has a question after business hours or the Project Manager is away, the customer typically must wait for the weekly meeting or call. With StudyWorks, all study information is at the customer’s fingertips at all times. Study coordinators in particular cite the unique ability of PHT’s ePRO solution to track and manage patient performance, diary compliance, and even hardware shipments of eDiaries.
SmartReports™ -- Putting the “Smart” In Reporting
eCOA data must be accurate, relevant and understandable; SmartReports delivers all three - and more. SmartReports includes a broad array of over 18 standard reports.
SmartReports includes dashboards, alerts, custom reports, mobile reports, and data exports to insure you have the data you need, where and when you need it. SmartReports are easily translated into sites' local languages and use graphics and color coding to facilitate ease of use. SmartReports turn data into knowledge.
SmartReports is the most powerful tool available for viewing, managing and understanding clinical research trial patient data. Its interactive interface is intuitive and provides an unprecedented level of detail within patient data reports. This enables project managers, monitors and sites to sort by report headers; drill-down within subject and site data; and view reports in native language translations.
SmartReports delivers on the PHT ability to anticipate the evolving reporting needs of the ePRO market. The PHT active dialog with our clients coupled with our unmatched scientific and business expertise enables us to take ePRO solutions to another level.
StudyWorks always sets the standard for completeness of reports offered and usefulness of data in eDiary trials. SmartReports raises the bar on reports for managing compliance, eligibility, and enrollment – all the aspects of successfully integrating ePRO data in clinical trials. Being able to sort on subject and site data saves a lot of time.
SmartReports runs entirely within StudyWorks with no plug-ins or additional software. It enables enrollment, compliance and eligibility reports to be displayed in many different languages. This is particularly useful and advantageous for clinical sites that prefer to view reports in their native language.
SmartReports™ Mobile – On the Go Mobile Compliance Monitoring
SmartReports Mobile™ enables sponsors, monitors and study coordinators to check subject compliance from any smartphone 24/7365 days a year.
Study Monitors are busy, but your data can’t wait until they’re back in the office. Monitor relevant compliance on-the-go with SmartReports Mobile on your Smartphone. Instinctive color coding lets Monitors know what to focus on and drill-down capabilities brings them quickly to the point of concern. Site contact information features click-to-call technology.
SmartReports Mobile grants site monitors instant access to every clinical trial site and subject compliance data, and compares that data against compliance protocols. The app is free within StudyWorks®, PHT’s online clinical patient data reporting system.
The app brings mobile convenience to clinical trial compliance monitoring. SmartReports Mobile lets monitors stay completely updated and enables them to drill down on patient compliance and safety anywhere – airport, hotel lobbies, between meetings, wherever – without opening a laptop.
Monitors can check that sites and subjects are within compliance rates specified by the protocol and can quickly locate subjects who need follow-up. One tap immediately calls the site to expedite any issues. Many sponsors report that clinical trial sites which frequently check compliance reports often have higher compliance rates. SmartReports Mobile users also can tap on the site to activate the GPS capability of the smartphone to locate the site quickly.
MyStudyHome improves site engagement, reduces costs, and increase compliance.
MyStudyHome™ connects pharmaceutical sponsors and CROs with sites to share up-to-date training and documentation, calendars, and study specific updates. MyStudyHome gives sponsors and CROs a competitive edge in retaining high performing clinical trial investigation sites and improving site engagement and compliance.
MyStudyHome is part of the PHT StudyWorks® portal which delivers real-time access to electronic clinical outcome assessment (eCOA) data collected via the LogPad®, SitePad® or NetPRO™ Systems. MyStudyHome gives investigator sites centralized, single sign-on access to their eClinical systems in addition to their news, training, and study-related content, all in one place. Real-time information and feedback throughout the study enable sponsors and CROs to track progress and keep sites on track and compliant.
MyStudyHome streamlines interaction between sites and sponsors increasing the quality and speed of study communications. MyStudyHome provides secure single-sign-on across eClinical Systems allowing sites to use just one login and spend more time on what matters most: their patients.
Philip Lee, President & CEO –Since joining PHT in 2003 Phil has leveraged his 20 years of entrepreneurial expertise in the clinical research community to drive the global adoption of ePRO technology. Previously Phil was President and CEO of Clinsoft/Domain Pharma Corporation, a provider of clinical data management and adverse event reporting systems acquired by Phase Forward and Oracle. He also was President of eXcelon Corporation and held executive positions at Oracle, Interleaf and BBN Software Products. Phil has a BS and ME in Operations Research/Industrial Engineering from Cornell University.
Steven Rosenberg, Chief Operating Officer –Steve has redefined the eClinical business and the critical role of technology in clinical research. For more than 30 years he has led product and business operations at some of the Boston-area’s most successful high tech companies. Previously Steve was Vice President of Software and Services, Health Sciences Global Business Unit at Oracle Corporation. Prior to Oracle he was Senior Vice President of Software and Services for Phase Forward, where he was instrumental in the company’s IPO and $685 million sale to Oracle.
Sheila Rocchio, VP of Marketing and Product Management – Sheila has changed the face of clinical trial management by introducing new apps that make adopting ePRO a sound scientific and business decision. Sheila joined PHT in 2000 to ensure that PHT delivers products that delight trial sponsors, sites and patients. Previously she held executive product and project management positions at MicroStrategy (MSTR) and American Management Systems. Sheila has a BS from MIT and an MBA from Boston College.
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