Bridget Lane

About Bridget Lane

As an eCOA consultant, project leader, and digital solutions designer, I\'ve helped to improve how clinical outcomes are measured, implemented, and experienced across global clinical research. I have extensive experience in translating complex clinical, scientific, and regulatory requirements into accurate and compliant digital assessments that drive better data, decisions, and outcomes for patients and clinical study teams.My path into eCOA began in academic research at the University of Pittsburgh, where I spent eight years managing large-scale clinical studies, coordinating regulatory submissions, and designing study operations from the ground up.As I transitioned into industry roles with ERT, Covance, and later ICON, I gained experience in eCOA solutions design, user acceptance testing, and the end-to-end digital implementation of COAs. I’ve led the design process for complex, multi-site clinical trials; written specifications and technical drawings; built large-scale UAT strategies; and collaborated with project, product, regulatory, and quality teams to ensure every digital solution meets the highest quality standards.In my current role as an eCOA Consultant and Implementation Specialist with ICON/MAPI Research Trust, I serve as an SME for internal teams, clinical sponsors, and questionnaire developers. I evaluate COAs for electronic migration, lead eBooklet design, advise on endpoint strategy, and develop training programs used by teams around the world. I’ve authored or reviewed more than 120 medium-to-high complexity eCOA booklets and guides.I’m passionate about advancing how we design and deploy clinical outcome assessments, especially as the industry continues moving toward patient-centric, technology-driven research. I thrive in collaborative teams, enjoy sharing knowledge, and am excited about solving problems that make clinical trials run smoother and smarter.I am excited to build my network of other industry professionals. Please feel free to reach out.

Experience

1. Ecoa Sme and Electronic Migration Specialist

   ICON plc

   Sep 2022 — Present · Remote, PA

   As an Electronic Clinical Outcomes Assessment (eCOA) Consultant and Implementation Specialist, I am an eCOA subject matter expert (SME). I am successful in delivering strategic guidance and consulting to internal teams, eCOA vendors, sponsors, and questionnaire developers on managing and optimizing eCOA systems; integrating eCOA systems across clinical trials; evaluating clinical outcome assessments (COAs) to ensure complexity, suitability, and completeness when transitioning from paper to electronic formats; and facilitating meetings with COA authors to gather requirements, launch specification development for eBooklet design, and deliver feedback on eBooklets created by other authors. Key highlights include: Write Standard Operating Procedures (SOPs), daily Work Instructions (WIs), and how-to guides for the group. Author, create, and review over 120 medium-to-high complexity eBooklets and guides comprised of eCOA specifications, technical drawings, and screen designs. Develop and implement training programs and training materials for large groups of 40-60 MAPI Research Trust teams on specific questionnaires, eCOA best practices, migration, and technical design concepts. Provide technical support to ensure eCOA systems adhere to study protocols, industry regulations, and company policies.

Education

• Duquesne University

  Master's Degree, Health Policy Analysis and Administration

  2004 — 2007

• Carlow University

  Bachelor's Degree, Philosophy

  2000 — 2003