Digital transformation is well underway in clinical trial management as most Sponsors and CROs are moving towards electronic Trial Master Files (eTMF) and other digital solutions to manage their trials. But, there is a learning curve to understand and ensure interoperability, eTMF data sharing and standards. This webinar will explore flexible standards-based approaches to consistently and seamlessly share your eTMF data with partners, vendors, Sponsors and CRO’s.
This is the first of 2 webinars for eTMF best practices and standards. (target October for Webinar #2). Participants in both series will receive an eTMF Best Practices certificate from SureClinical.
Zack Schmidt, Founder and CEO, SureClinical eClinical Applications; OASIS Open Standards Organization, Founder and elected Chair, eTMF Standard Tech Committee
Zack is CEO and Founder of SureClinical, a health science applications company with global operations in the US and Europe. As founder and the first elected Chair of the OASIS eTMF Standard Technical Committee, Zack worked with technology innovators from leading software system vendors, industry, government and standards groups to publish the first draft ETMF technology standard for data exchange under OASIS Open, a leader in technology standards development that’s recognized by ANSI, ISO, ITU and many other standards bodies globally. The OASIS draft eTMF technology standard is currently in use or has been used on over five hundred clinical trials by sponsors, CROs and sites, for pharma, bio and medical devices applications.Message Presenter
Chet Ensign, Chief Technical Community Steward, OASIS
Chet Ensign ([email protected]), Chief Technical Community Steward, helps technology teams at OASIS work within the organization’s framework to achieve the goals set out in their charters and grow robust communities of adopters and implementers. He plays a major role in setting OASIS strategy, policy, and new programs.
Chet supports teams working in subject areas as diverse as cybersecurity, e-commerce, key management, legal technology, cloud computing, IoT, energy markets, and emergency response.
Actively involved with the consortium since it was founded in 1993, Chet joined the staff in 2011. He is based in Basking Ridge, New Jersey, USA.Message Presenter
Who Should Attend?
This webinar will be of interest to senior professionals in the following roles:
- VP of R&D IT
- VP/Head, Director/Senior Director of Clinical Operations
- Director of Outsourcing
- Director of Vendor Management
- Director of Clinical Trials
- Director of Strategic Development
- Clinical Trial Manager/Specialist
- Clinical Data Manager
- Clinical Research Manager
- CTMS Coordinator/Manager
- Clinical Study Lead
- Clinical Trial Associate (CTA) / Clinical Research Associate (CRA)
- Quality Manager
What You Will Learn
- Why standards are important to enable eTMF interoperability
- How standards makes it possible to consistently and seamlessly share your data with partners, vendors, Sponsors and CRO’s
- Difference between standards and models
- TMF structures and agency requirements
- How an electronic filing structure differs from a paper filing plan
- Introduction to eTMF content tagging using standards-based terms based on standards body definitions by NCI, FDA, HL7 and CDISC and others
SureClinical is a premier provider of FDA and EU compliance validated health science cloud applications. Our mission is to provide unified best-in-class applications to accelerate the delivery of innovative therapies to patients globally.