Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
Webinars
Rationale, Lessons, Outcomes: eClinical Solutions’ Experience of SCE Adoption
Adopting a statistical computing environment (SCE) can bring significant benefits to clinical research organizations and sponsors. By providing a platform for automating processes, and enhancing collaboration, SCEs (Statistical Computing Environments) have the potential to improve efficiency and traceability.
eClinical Solutions’ Biometrics Services team recently adopted elluminate® SCE to streamline biostatistics and programming deliverables.
In this webinar, Demi Niforos, VP of Biostatistics and Programming, Debora Knepp, Principal Programmer, and Donna Storrs, Manager Statistical Programming will discuss their rationale for adoption, lessons learned, and expected outcomes for biometrics services clients. The team will review practical ‘then and now’ scenarios, revealing how the SCE adoption has changed workflows for specific use cases. Finally, they will discuss the future-state applications of SCE within the biometrics services group. They will be joined by Nathan Johnson, VP Digital Innovation, who will share his latest insights on how SCE within the elluminate Clinical Data Cloud is helping clients to meet the evolving demands of clinical trials and maximize data value.
Join us for this webinar to hear first-hand experiences of how adopting an SCE can help organizations achieve enhanced biometrics deliverables, and how to navigate the challenges and opportunities of implementing an SCE.
What You Will Learn
- The drivers for adopting an SCE
- Overcoming challenges and lessons learned from practical experiences
- Near-term impacts and outcomes of implementation
Presenters
Principal Programmer, eClinical Solutions
Debora Knepp is a Principal Statistical Programmer for eClinical Solutions and has more than 30 years of drug development experience in nearly all clinical research environs including big, mid-size, small and start-up pharma, biotech, CRO, government and academia. She started her clinical research career in data management, had a brief stint as a clinical research associate, developed training programs and taught a comprehensive clinical research science course for multiple pharmaceutical companies and CROs before settling into statistical programming. She is passionate about clinical research, data in particular, and continues to train and mentor anyone willing to listen and learn.
Vice President, Biostatistics and Statistical Programming, eClinical Solutions
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics and data management across multiple companies including YM Biosciences, Viventia Biotech and AAIPharma. She has extensive expertise in the clinical development process from study planning to agency submission. Prior to joining eClinical Solutions, Demi led Biostatistics and Data Management for Arbutus BioPharma. Demi holds an M.S. in Applied Statistics from Worcester Polytechnic Institute and a B.S. in Mathematics and Science from Worcester State College.
Manager Statistical Programming, eClinical Solutions
Vice President, Digital Innovation, eClinical Solutions
Nathan Johnson is Vice President, Digital Innovation at eClinical Solutions. Nathan has 20 years experience in clinical research as an innovator and programmer with expertise in statistical analysis and reporting, SAS programming, standards development, and data management. He is passionate about reshaping clinical trials through digital transformation, intelligent technology, and increased automation. Nathan has a Masters in biostatistics from Case Western Reserve University.
