eTMF System Day Agenda
Wednesday, December 9, 2020
All times are in EST
Paul Fenton's keynote will give us a quick history of eTMF systems, and discuss how the systems that we use today will evolve to unlock the true value of eTMF information. He will highlight some key areas of development for new functionality which will significantly facilitate clinical trial conduct both today and in the future. He will also discuss some of the challenges that the industry currently faces with TMF management and approaches that we could take to overcome them. This keynote will set the scene for the rest of the days talks and panels.
President and CEO
Investigator sites participating in industry clinical trials are expected to establish and maintain a comprehensive Investigator Site File throughout their trial participation. Many essential documents expected at the site level are already present in the sponsor-established Trial Master File; the TrialSpark Hybrid eTMF and eISF model, leveraged in Montrium eTMF Connect, eliminates duplicative work, unnecessary monitoring and site-level ISF/TMF Health uncertainty. By granting Investigators and site staff restricted access to the applicable zones of the TMF, TrialSpark is able to maintain a highly accurate TMF while also engaging the site more directly as they submit documents directly to the study TMF. By reimagining the way we approach TMF documentation we are able to actualize TrialSpark's mission; to bring new study treatments to patients faster and more efficiently."
Director of Site Operations
- Develop a records management plan to improve the process from draft to approval to finalization
- Enhance retention and archiving
- Develop and streamline process utilizing a technology platform
Director of Regulatory Affairs
Head of TMF Operations
With so many eTMF solutions now available, it is important to understand and clearly define user requirements and expectations before selection an eTMF solution. Using case studies, this presentation will provide guidelines to help devise smart strategies and processes to evaluate the options and ensure selection of a secure, robust, scalable and efficient eTMF best suited to the organization and its need. It will also provide examples of maintenance and how best to road map out your eTMF once it’s procured.
Chief Innovation Office
TMF management is constantly evolving to support the regulatory changes. In the panel session you will hear about the latest trends, insights and inspection needs that are impacting the future of eTMF including:
- Best practices to prepare for a remote inspection
- Impact of interoperability
- Data integrity
- TMF Reference Model 3.2
President and CEO
Associate Director of Document Management