PICI’s Best Practices for Building Oncology Studies in an EDC

Life Sciences, Clinical Trials, Pharmaceutical, Drug Discovery & Development,
  • Thursday, February 04, 2021

The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.

Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:

  • Umbrella trials that evaluate multiple therapies
  • Adaptive trial branching and routing
  • Having an unknown number of treatment cycles
  • Amendments and other unplanned changes

Register now to hear experts from PICI explain how to streamline the building of oncology trials with new EDC technology.

Speakers

http://Toby%20Odenheim,%20PARKER%20INSTITUTE%20FOR%20CANCER%20IMMUNOTHERAPY

Toby Odenheim, Director, Technology and Governance, Parker Institute for Cancer Immunotherapy

In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.

Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.

Message Presenter
http://Gary%20Smith,%20Parker%20Institute%20for%20Cancer%20Immunotherapy

Gary Smith, Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy

Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.

Message Presenter

Who Should Attend?

This webinar will benefit those working on oncology trials with the following job titles:

  • Data managers
  • Database Programmers
  • Clinical Programmers
  • Clinical programmers in charge of building studies
  • Clinical leaders in charge of selecting EDC systems
  • EDC Programmers

What You Will Learn

In this webinar, participants will learn about:

  • The structure and benefits of an adaptive umbrella trial
  • How to replace repetition in builds with rules and dynamics
  • Advice for selecting and implementing a modern EDC
  • Strategies to minimize repetition and maximize reuse

Xtalks Partner

Veeva Systems

Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 950 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.

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