8:30 am Morning Networking & Registration

9:15 am Chairpeople’s Opening Remarks

Improving Internal & External Collaboration to Leverage eTMF Efficiencies

9:30 am Achieving Cross-Functional eTMF Buy In

  • Kate Santoro Director Clinical Operations TMF, Intellia Therapeutics

Synopsis

  • Reconsidering who should be responsible for the eTMF by changing the status quo
  • Understanding why cross-functional buy in will achieve a high-quality eTMF
  • Approaching how to engage the different groups

10:00 am Panel Discussion: How to Gain Cross-Functional Responsibility to Achieve TMF Quality

Synopsis

  • Outlining the steps to be taken to achieve group cross-functionally
  • Sharing successful case studies of how functional groups have been mobilized
  • Determining what ideal cross-functional collaboration would look like

10:30 am Illuminating Strategies for Best Practice in Site Collaboration to Strengthen Operations Between Sponsor, CRO & Site

Synopsis

  • Exploring how collaboration with sites, CRO and sponsors on eTMF health is vital for a successful trial
  • Discussing site’s best practices on operations, processes, and appropriate oversight to make a healthy eTMF
  • Addressing the site frustrations such as ISF oversight, lack of transparency and communications
  • Educating on some solutions for a healthy ISF to eTMF relationship

11:00 am Speed Networking & Morning Coffee Break

Synopsis

This session is the ideal opportunity to get face time with the brightest minds working in clinical research. Establish meaningful business relationships to pursue for the rest of the conference
Grab a cup colour which corresponds to your choice in topic of conversation and
get stuck in!

Operationalize Your Tech to Streamline Your Operations

11:45 am Maximizing Your System’s Potential by Understanding Your System’s Needs

Synopsis

  • Identifying how your system needs can be determined to best understand your goals
  • Approaching how to leverage your eTMF to support your goals and maximise your system
  • Encouraging enhanced service provider communication to improve support and awareness of system capabilities

12:15 pm Showcasing How eTMF & CTMS Systems can be Integrated to Drive a More Compliant eTMF

  • Nisi Nazim Senior Manager, Global Clinical Operations, BeiGene

Synopsis

  • Establishing data integrity by using your CTMS as a valuable source for study information
  • Understanding how milestones can be aligned between the systems to ensure better eTMF compliance and completeness
  • Exploring challenges associated with CTMS and eTMF integration while addressing current solutions used to overcome these them

12:45 pm Configuration Considerations, A Roadmap to a Cohesive eTMF

  • Candace Anderson Associate Director, Integrated Delivery Enablement Office, Parexel

Synopsis

  • Translating business needs into a configuration that looks at process, security, and deliverable as a holistic and cohesive system
  • Knowing what questions to ask your business stakeholders for configuration decisions
  • Understanding downstream impacts of system enhancements

1:15 pm Lunch Break & Networking

Enhancing Integration Between Systems to Support Interoperability

2:30 pm Panel Discussion: Exploring How Technology is Utilized Differently by Sponsor, CRO & Site to Understand How Best to Collaborate

  • Seneca Harrison Chief Executive Officer, Quality Clinical Research
  • Radwa Aly Senior Director Clinical Research Operations, GWU Medical Faculty Associates
  • Sarah Dean Executive Director, CTMS & eTMF, Precision for Medicine
  • Liz Farrell Director, Trial Master Files, Agios

Synopsis

  • Appreciating the various ways technology is implemented between groups to learn how to make your systems work together
  • Discussing best practices in collaborating between groups and systems by rethinking communication practices

3:15 pm Afternoon Coffee Break & Networking

TMF Industry Updates and Inspection Experience

3:45 pm TMF Reference Model: Yesterday, Today and Tomorrow

  • Karen Roy Senior Vice President of Clinical Marketing, Phlexglobal

Synopsis

  • Brief history of the TMF reference model
  • The move to CDISC – what does it mean for you?
  • Where are we going?

4:15 pm Panel Discussion: Lessons Learned from a Recent Inspection to Ensure you are System Compliant

Synopsis

  • Hear from sponsors, CROs and sites about what has been brought to attention in previous inspection to understand what being inspection ready really means
  • Distinguishing whether inspection requirements and areas differ between sponsors, CROs and sites

5:00 pm Chairpeople’s closing remarks

5:10 pm End of Conference Day One