PHT helps pharmaceutical clients collect compliant patient-driven eData through innovation and education

Some of the new clinical trials leverage the PHT SitePad^® mobile eCOA data collection tablet to capture multiple patient reported outcomes (PROs) and clinical outcome assessments (COAs) at the site. Others integrate the PHT LogPad^® System, the most widely used electronic patient reported outcome (ePRO) System, with eSense™ Measurement Devices.

eSense integration with the LogPad System is soaring along with the growing demand for collecting and evaluating physiological patient measurements for diabetes and respiratory clinical research programs. eSense delivers high-quality, attributable 21 CFR Part 11 compliant-data wirelessly to each patient diary and to StudyWorks^®, a secure online reporting portal.

Additionally, PHT Consulting Services signed two new projects to help clients develop ePRO/COA trial design strategies for drug development programs. The team offers more than 200 years of collective experience in ePROs and COAs.

PHT President and CEO Philip Lee said:

"More and more pharmaceutical leaders, regulators and industry key opinion leaders recognize PHT’s unique value-add in enabling clients to conduct better research, speed the delivery of new drugs and treatments, and improve patient quality of life."

Q1 Highlights Also Included:

Industry Education – PHT Europe General Manager, Valdo Arnera, MD, spoke and presented a scientific poster at industry events including the 5th Annual Patient Recruitment and Retention in Pharma, the 25th Annual DIA EuroMeeting, and the ACDM 2013 Conference.

PHT Senior Scientific Advisor Dr. Susan Dallabrida conducted a new webinar, "Adult Oncology: Clinical Outcome Assessments (COAs) & Patient Reported Outcomes (PROs)" which highlighted scientific literature-based best practices and regulatory guidance for researchers incorporating PROs and Instruments in adult oncology trials.

Corporate Growth – Bill Barrasso joined PHT as Director of Client Services. Bill brings to PHT more than 20 years of experience in planning, execution, and risk management for complex delivery programs.

PRO & eCOA Congress, Baltimore – Regulatory topics were highlighted at the March meeting which featured a panel discussion and presentation by Jonathan S. Helfgott, FDA Compliance Officer for Center for Drug Evaluation & Research (CDER), on "FDA Perspective on the Compliant Use of ePRO Instruments to Support FDA Studies."

Watch a brief video on Congress highlights.

Register for the European PRO & eCOA Congress, 28-30 May in Evian, France.