A Medical Device Daily

etrials Worldwide (Morrisville, North Carolina), a provider of eClinical software for the collection, cleaning, integration and review of data in the clinical trial process, reported signing an agreement with the Cardiovascular Research Foundation (CRF; New York), a not-for-profit organization dedicated to promoting advances in cardiovascular medicine, specifically interventional cardiology, and the diagnosis and treatment of endovascular disorders.

The agreement is for a global Phase III study that in-cludes 200 study sites and more than 3,000 patients. Proj-ect implementation is currently under way and patient en-rollment will begin in the current quarter.

“In order to best gain insight and elevate the quality of care provided to patients with cardiovascular disease, we strive to provide the best tools and processes to our investigators to help guide critical research and novel devices from conception to approval,“ said Victor Yick, president of CRF. “We selected the etrials platform for this study because [it] saves valuable time and enables us to work within an accelerated timetable for a rapid implementation.“

CRF will use etrials' eClinical platform, which is designed to enable study personnel to capture and share study information via electronic case report forms. The platform also will enable investigators to utilize an interactive voice response system that will manage clinical supplies, automate patient randomization, collect patient data, coordinate subject visit tracking and manage investigator sites via the telephone, as well as analytics tools to run standard and custom clinical reports.

PhDx Systems (Albuquerque, New Mexico), a provider of software and services for documentation of medical outcomes, said it has signed an agreement with Smith & Nephew's (S&N; London) Orthopaedics Division.

PhDx is providing S&N with web-based outcomes software services to conduct multiple post-market studies to track, measure and evaluate the results of surgical procedures using S&N knee and hip components.

PhDx will develop S&N-specific hip and knee data collection surveys and schedules to track implanted devices in these post market studies. The multi-center studies will follow and compare patients from pre-surgical treatment through surgery for up to 10 years and will measure clinical and radiographic data, patient functional status and satisfaction, resource utilization and validate device outcomes.

Geoff Mather, PhDx president, said, “Our web-based orthopedic application will enable [S&N] to collect real-time, comprehensive outcomes data while enabling physicians to compare their individual practice data with that of the entire study group.“

No Comments