eCOA Implementation: End-User Education and Support

  Aubrey Llanes, Product Director, eCOA Technology-driven tools that transform clinical research are key to enhancing clinical trial efficiency, protecting data integrity and helping to bring new therapies to market faster. The use of patient-centric technology, such as electronic clinical outcome assessment (eCOA) tools are an important building block for collecting more reliable endpoint data.…

eClinical Shifts Left

Mark Maietta, President and Chief Commercial Officer Shift Left ignited a revolution in modern software development with the concept of early and continuous testing, resulting in higher quality and faster delivery. The Shift Left principles focus on continuous integration and delivery, a practice designed to find and prevent defects early vs. later in the software…

ePRO Risk Mitigation During the Coronavirus Disease 2019 (COVID-19) Pandemic

Celeste A. Elash, Director, eCOA Science On April 10, The Critical Path Institute (C-Path) released their presentation titled “Coronavirus Disease 2019 (COVID-19):  Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites”.   This risk mitigation plan was a collaboration among C-Path, the Electronic Patient-Reported Outcome (ePRO) Consortium and the Patient-Reported…

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…

IRT’s Role in Clinical Trial Continuity

Andrew Rohrbaugh, Vice President, Strategic Solutions As the Coronavirus (COVID-19) pandemic continues to impact clinical trials globally, we have seen a significant shift in focus to trial continuity – identifying ways to ensure that existing study participants are able to continue receiving investigational product, and maintain their participation in an ongoing clinical trial. Distribution vendors…

Strengthening eClinical Data Integrity Series – Part 3: Enhanced Compliance Strategies

Terek Peterson, MBA, Vice President Customer Experience and Data Science As the use of eCOA expands to incorporate more submission-critical elements, especially key endpoints and factors contributing to per protocol analyses, customized compliance strategies are more important than ever to ensure data integrity. By following ALCOA principles for data integrity, quality assurance processes, system controls…