Validated instruments that measure patient symptoms, mental state and disease progression as clinical endpoints have traditionally been developed on paper. Increasing adoption of electronic clinical outcome assessments (eCOA) has resulted in a surge of legacy instrument migrations from paper to electronic formats. The process is time-intensive, requires multiple stakeholders and is often complex.
In this webinar, Catherine Aquadro, MD of MAPI and Donna Mongiello of YPrime will discuss the advantages of COA development directly on an electronic platform, completely eliminating the steps and cost involved with migration. Discussion includes:
- The paper to electronic migration process
- The good, bad and ugly – Case examples, from successful to migrations gone awry
- eCOA technology solutions & associated benefits
Catherine Aquadro, MD, Head of Thought Leadership, Mapi
Catherine Acquadro, MD is Head of Thought Leadership at Mapi. A recognized COA expert, she has been working in the field of outcomes research for more than 25 years with a focus on cross-cultural research.
Catherine launched Mapi’s linguistic validation (LV) activities in the early 1990s with her involvement in the International Quality of Life Assessment (IQOLA) Project and the development of the LV methodology. Career highlights include serving as coordinator of the European Regulatory Issues on Quality of Life Assessment (ERIQA) project for the recognition of patient-reported outcomes in the evaluation of medicinal products, and as the coordinator of the PRO Harmonization Group in collaboration with the FDA.
Donna Mongiello, RN, BSN, Vice President, Strategic Solutions, YPrime
Donna Mongiello is Vice President, Strategic Solutions for YPrime. Bringing twenty years of business development and operational leadership in eClinical and digital health solutions, she is a recognized expert in patient recruitment, retention and electronic clinical outcome assessment (eCOA) topics.
Donna’s nursing background and industry career supporting sponsors have instilled a strong desire to improve clinical research from the patient’s perspective, simplify study conduct and make study participation less burdensome for patients.
Who Should Attend?
Managers/Directors/Vice Presidents of:
- Clinical operations
- Clinical outsourcing
- Clinical technology
- Data management
- Health economics/outcomes research
YPrime offers more than a decade of focused work with eclinical systems to expedite and improve the quality of patient management, clinical supplies, drug accountability and clinical data. Cloud-based interactive response technology (IRT) and electronic clinical outcome assessment (eCOA) platforms offer sponsors greater speed, precision and integration in clinical trial management.
Our data services and tools help sponsors bring together fragmented clinical research data into contextual information they can act on. YPrime’s technology and service offerings enable sponsors to move faster and more efficiently to their next development milestone.