The intersection between Sponsor and Site Trial Master File (TMF) lies in the processes, standards and technology supporting the TMF. In this webinar, TMF industry experts from Montrium and LMK will discuss how to improve the integration across the TMF managed by clinical stakeholders to ensure TMF health and improve remote collaboration, monitoring, records retention, and more.

The webinar covers the following topics:

• The current state of play for sponsors and sites
• Differences between sponsor and site TMFs
• How to implement cross-organizational processes to ensure completeness, quality and timeliness of cross organizations TMFs
• Leveraging models and standards
• The intersection of the TMF Reference Model and other Site TMF models
• How can we leverage technology to make things easier?
• Collaboration and interchange
• Remote monitoring
• Archiving and records retention
• Future trends

If you're a clinical operations professional, join us for a webinar you won't want to miss!

Speakers

Paul Fenton, CEO, Montrium

Paul has significant industry experience at a senior management level in the development, deployment, and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005 and has a strong background in CDISC and ICH standards, as well as in the integration of systems and processes for clinical trials. Paul is the co-chair of the eTMF-EMS standard initiative and TMF reference model steering committee model.

Sholeh Ehdaivand, CEO, LMK

Sholeh is a TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes have made her a leader and trusted authority. Her experience includes the TMF Reference Model (Sholeh is a Lead for the TMF Quality Subgroup and Current Member of the Steering Committee), eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes, and implementation and regulatory inspection preparation and participation. Sholeh is currently the Principal Consultant and President and CEO of LMK Clinical Research. She is an Ambassador for the Metrics Champion Consortium's (MCC) TMF initiative. Sholeh is a founding member and co-lead of MAGI’s Investigator Site File (ISF) Reference Model initiative, which is currently being used by hundreds of sites around the world!