The PHT eCOA System – Patient-Driven eData for Better Outcomes

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.

A Proven eCOA Experience

Patients, sites, and sponsors report positive experiences using the integrated PHT eCOA system. Patient-driven eData collected and analyzed with the PHT eCOA system enable faster analysis using fewer patients. Real-time access to quality patient data via StudyWorks™ streamlines site processes.

Compared to paper COA, electronic data collection has been shown to reduce data variance and require smaller sample sizes while increasing patient compliance. PHT consults on all aspects of collecting and managing COAs with scientific, regulatory, data management, and health outcome expertise

How it Works:

1. Scientific review of protocol to recommend optimal data collection device and design
2. Rapid development of eCOA system with ePRO Designer
3. Patient, clinician, or observer enters patient data into the LogPad/SitePad or PRO anywhere
4. Data entered are eSource and attributable, device provides reminders, safety calculations, and notices to patients and clinicians.
5. Data are transmitted to PHT’s StudyWorks online portal via 3G, WiFi, Analog,
6. and/or the Internet.
7. Clinician, trial manager, and investigator view collective data online, anytime

Record Your Compliant Data Anywhere

The eCOA system integration begins with a complimentary PHT scientific review of your protocol to recommend the optimal device and instrument design. Diaries and questionnaires can be deployed on one or more device types, and integrated with eSense medical devices to also secure objective measurements from patients.

LogPads, SitePads, and NetPRO are used by patients at home, on-the-go, and at the site to record their experiences anytime. Patient-driven eData is sent to a secure central server where it is instantly available for real-time review by sponsors, sites and CROS via StudyWorks. Upon study closeout, PHT produces an XML source data archive that can be used to reconstruct the trial.

Accessible and Secure

Instantly access the latest patient data &and trial management information. All eSource data collected are immediately available via the StudyWorks secure online portal, enabling rapid analysis and review. FDA and other regulatory authorities have approved at least 16 new drug applications that include endpoint data from the PHT eCOA System.

PHT eCOA expertise from 600+ trials includes a wide variety of therapeutic areas, indications, patient demographics, and clinical site locations around the world. PHT offers the regulatory, technological, and scientific expertise today’s market demands and patients deserve.