PHILADELPHIA– October 15, 2015 –– ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions today announced the complete faculty and agenda of its 8th Annual U.S. PRO and eCOA Congress in Washington, DC, October 27-29, 2015. The 2-day educational Congress will provide case studies and pragmatic information on the clinical science, regulatory and innovative technologies for effectively implementing Patient Reported Outcomes (PRO) and electronic Clinical Outcome Assessments (eCOA) strategies in clinical development.
The U.S. Congress covers a broad range of topics pertaining to the current PRO / eCOA environment, including wearable innovations for clinical use, regulatory perspectives on eSource, and critical rater training and centralized rater performance surveillance. Attendees will participate in large and small group discussions led by international biopharmaceutical, regulatory, and industry experts, including:
- Jonathan Helfgott, Director of Regulatory Affairs at Stage 2 Innovations, and former Associate Director for Risk Science, Intelligence, & Prioritization, U.S. FDA CDER will present “Wearables and Objective Measurement: What’s the Secret?”
- Kate Delaney, Sr. Psychometrist and Consultant, Shapiro & Delaney, LLC will present “Case Study: Implementing a 500-Question Instrument with High Compliance.”
- Cancer Survivor and Legislative Advocate Jack Whelan will present his personal and oft- humorous bumpy ride on the road to Personalized Medicine with “Innovations in Clinical Trials to Improve the Patient Experience: Case Study & Innovations in Beta Testing.”
Congress attendees will also see demonstrations of select concepts currently in beta testing at ERT’s Boston-based Innovation Lab, where dedicated scientists and technological experts collaborate with partners in developing new technologies that enhance the collection of patient research data. Examples of concepts that will be demonstrated at the Congress include:
- eCOA Study Designer for Rapid Prototyping
- Localization Tool with Translation Preview
- Biosensor with Fall Detection and Pulse Rate Diary Integration
- Bluetooth Blood Pressure Cuffs Comparison
- CleverCap™ Medication Dispensing
“We are pleased to gather so many industry experts to share practical, real-life information on the important role patient data has in meeting clinical development objectives,” said Ron Sullivan, Executive Vice President, eCOA at ERT. “We are also excited to give attendees hands-on experience with novel prototypes we are developing – an opportunity normally reserved for visitors to our Innovation Lab.”
ERT is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services and clinical consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Switzerland, Japan and Germany. Join ERT on Facebook, LinkedIn, Twitter, and YouTube.