April 2, 2020
YPrime Expands eCOA Offering for Remote Data Collection in Support of COVID-19 Clinical Trial Continuity
MALVERN, P.A., April 2, 2020 – As the spread of the COVID-19 pandemic continues to impact global clinical trial continuity and patient access to clinical care, YPrime today announced the release of web-based electronic clinical outcome assessments (eCOA) solutions to support remote data collection during challenging and uncertain times.
“Site and patient-level considerations have been central to YPrime’s eCOA design since inception,” said Mark Maietta, President of YPrime. “For sponsors needing rapid alternatives, we adapted functionality from our existing web backup tool to provide expanded functionality at the site level, where there is significant need for versatile options to collect data and reduce site and patient burden.”
Sponsors looking to shift on-site patient data collection to enable virtual participation have several different options for execution flexibility:
- Web access to site-based patient-reported outcome (PRO) assessments: To assist in data collection continuity in the wake of investigator site closures and “stay at home” mandates, patients with upcoming visits that require site-based ePRO assessments can complete visit-specific questionnaires from home or other remote location via a web-based tablet emulator.
- Web access to site-based clinician-reported outcome (ClinRO) assessments: Site users who conduct ClinRO assessments through a tablet device can access assessments through a web-based study portal.
- Web access to field-based assessments: Patient users who have been issued a handheld device for home-based PRO assessments may complete assessments via a web-based handheld device emulator in the event of device loss or malfunction.
- The use of a web-based emulator of actual devices minimizes both missing data and risks to data integrity.
YPrime’s expedited eCOA deployments are enabled by an agile development process. Support from experienced project managers and global helpdesk coverage ensures protocol-specific solution design, forward-looking risk management throughout a clinical study and quick resolution of technical issues. YPrime’s eCOA scientists are available for consultation to help sponsors maintain clinical trial continuity and navigate regulatory guidance during the COVID-19 pandemic.