Patient-reported outcome (PRO) and electronic PRO (ePRO) measures are standard tools for directly eliciting the patient experience for clinical outcome assessments (COA). Ever since regulators approved quality of life (QoL) data sufficient to prove efficacy, clinical trials have been leveraging COAs and electronic COAs (eCOA) for submissions.
In this webinar, the presenters will examine three key benefits of electronic clinical outcome assessments: reduced data variance, increased patient compliance and reduced site monitoring costs. Hear lessons learned and experience gained from real-world trials collecting eCOA data.
Industry trends, research and best practices in eCOA will be discussed, including:
- Regulatory mandates & recommendations;
- Patient eData adoption and trends;
- eCOA case studies of increased compliance & data quality;
- Comparisons of monitoring costs for eCOA vs. paper; and
Elisabeth Kurkimilis, Senior Manager of Clinical Operations, Celgene Corporation
Elisabeth is a senior manager of clinical operations at Celgene Corporation. She is currently responsible for a Global Phase III Program in the inflammation and immunology department at Celgene. The program spans over 20 countries and is comprised of four trials enrolling 2000 subjects. Elisabeth has over 25 years of experience in the Pharmaceutical industry starting her career as a study coordinator, then as a CRA and currently as a senior study manager. Therapeutic areas that Elisabeth has worked in include: anti-infectives, chronic and acute pain management, asthma, oncology, and inflammation and immunology. Elisabeth is located in Eagleville, PA and has her BS from the University of South Florida.
Valdo Arnera, MD, General Manager Europe, PHT Corporation
Valdo is a physician, scientist and entrepreneur who has advanced Pharmaceutical research for over 20 years. Since founding PHT Europe in 2001, he has opened multiple geographies for PHT. Valdo received the SCRIP Journal Lifetime Achievement award for his work in advancing clinical research, and has been named to the PharmaVOICE 100 list of the most influential people in the life sciences industries. Previously he founded the first European Central Clinical Laboratory, which became the Covance Central Laboratory, and practiced medicine. Valdo has published articles in top industry publications, and speaks frequently at events which foster clinical research advances. He received his French State Doctor’s Degree in Medicine from the University of Clermont-Ferrand I.
Who Should Attend?
Pharmaceutical, biotech and CRO professionals involved in:
- Data Management
- Clinical Operations
- Health Outcomes
- Medical Affairs
- Regulatory Affairs
PHT Corporation is the eClinical innovator leading the adoption of patient-driven mobile apps for better clinical research. The PHT electronic clinical outcome assessment (eCOA) system collects and reports secure real-time patient data from the latest mobile devices. PHT scientific, regulatory and technological expertise combined with quality outcomes data enable clients to make research decisions with confidence. Sponsors and CROs have leveraged the PHT Patient Suite in 650+ trials resulting in 17+ regulatory approvals. Visit phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Facebook, Twitter, Google+ and YouTube.