Connecting the Industry
To Advance Strategic TMF
Agenda
Tuesday, April 1
Wednesday, April 2
Top Biopharma: Changing TMF Operating Models for Simplicity and Connectivity
A top biopharma shares how a new TMF operating model will enable simplicity and improve connectivity across the business and with sites. This includes practical tips for change management and examples of key processes to simplify.
Emerging Biotech: Strengthening CRO Partnerships for TMF Quality and Efficiency
An emerging biotech’s head of TMF shares lessons learned from current and former companies, including how to build an operating model on strong CRO partnerships and align processes and metrics for TMF teams of all sizes.
Discussion: Understanding the CDISC TMF Reference Model Revision and Roadmap
CDISC shares how organizations can prepare for the latest revision of the TMF Reference Model, which aims to standardize and digitize the historical model. Discuss key takeaways from the revision, steps to prepare your organization, and what’s next on CDISC’s roadmap.
Discussion: Strategies to Improve Site Collaboration
More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.
Top Biopharma: Improving TMF Governance With Insights From Industry Assessment
A top biopharma shares insights from a TMF industry assessment it conducted with large biopharmas, small biotechs, and CROs to understand how they govern repositories other than the primary TMF. This includes actionable steps to reduce sub-repositories and improve governance.
Discussion: How Technology Can Help Make Data-Driven Decisions
Discuss with peers how to use technology to identify actionable insights from your data. Veeva will also share TMF trends across studies that can inform decision-making.
Discussion: Strategies to Improve Site Collaboration
More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.
Biotech Panel: Unifying Clinical Processes and Teams with TMF
TMF experts from emerging biotechs share lessons learned about working cross-functionally and creatively solving challenges, all with lean teams and small budgets. Hear about their latest inspection experiences, methods of influencing users and stakeholders, and strategies for driving real-time TMF completeness.
