During COVID-19, regulators and sponsors show pragmatism and flexibility in terms of mitigating challenges in the current climate. The combination of digital distribution, innovation, and flexibility enabled the clinical trial community to expedite
drug development during the COVID-19 pandemic while also minimizing risks to patient and trial success. During this session, we will explore how new and reimagined technology innovations are addressing the impact of COVID-19.
- Minimizing challenges arising as shelter in place guidelines are relaxed with limited onsite capacity and increased demand for onsite monitoring visits
- Minimizing trial monitoring risks through guided evaluation of quality data, mitigation, and risk control mechanism strategies
- Leveraging next-generation analytical tools and algorithms to support remote monitoring and maintain oversight
- Securely and remotely performing critical document management and source document review (SDR)
Michelle Wetherby, MS
Director, Global Clinical Trial Support Services, Boston Scientific
Michelle Wetherby has over 20 years’ experience and currently serves as Director, Global Clinical Trial Support Services at Boston Scientific. In this role she is responsible for development and conduct of various Centers of Excellence supporting clinical research. Prior to joining BSC, she held several industry roles focused on the conduct of global medical device trials, most recently in the development and implementation of a novel risk assessment tool and risk based monitoring framework to support a novel monitoring approach. Ms. Wetherby is adept at assembling global teams to provide scalable central services to support critical clinical trials activities. Ms. Wetherby has a Master’s Degree from St. Mary’s University and has presented and published on the topic of risk based monitoring.
Adaptive Clinical Strategy Partner, Premier Research
Deb Jendrasek has been a part of the clinical industry for more than 20 years, holding various positions within data management, strategic development, and clinical operations. In her current role at Premier Research, Ms. Jendrasek is responsible for developing processes, implementing technology, and building expertise within the company to enable and enhance risk-based study execution. She also leads her team in ensuring the holistic oversight of clinical site performance to proactively direct monitoring efforts. Ms. Jendrasek is experienced in leading the deployment of data-driven innovations to improve the efficiency and productivity of monitoring processes and data cleaning practices, following all applicable regulatory guidelines including ICH E6 (R2). Ms. Jendrasek has a bachelor’s degree in Computer Information Systems from Bentley University. She is a member of the RBM Working Group of the CRO Forum.
Vice President, Product Management, RBQM, Medidata
Lisa is the Vice President of Product for Risk-Based Monitoring capabilities for Medidata Solutions. She has nearly 20 years of pharma, biotech, and medical device industry experience, delivering complex system solutions in support of excellence in clinical trial execution. Lisa has spent time both in consulting and in Information System leadership for Amgen, directing architecture and development of the Clinical Trial Management ecosystem. While at Amgen, Lisa was also allocated to leadership roles within TransCelerate Biopharma, driving industry.
Director, Product Development, Medidata
Brian Barnes is a Director, Product Development – RBQM. Brian currently leads the Risk Management product development team. Previous to Medidata, Brian was in the CRO space for 15 years where he supported RBQM for the past 8 years specializing in RBQM operationalization for small to large pharma, biopharma, and biotech companies specializing in implementation of ICH E6 (R2). Brian is a co-liaison within the Associate of Clinical Research Organizations (ACRO) RBQM Working Group and presented and published on the topic of RBQM within a number of industry meetings, conferences, and journals.
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata, The Operating System for Life SciencesTM.