Quality Data...Delivered by Design™

Quality Data...Delivered by Design™



Past Event

Presentations and Topics We Can Bring to Your Organization

For more information or to bring these topics to your organization, contact Lorraine Ellis lellis@resdyncg.com


May 31, 2012

Lorraine Ellis will be presenting a webinar on "Best Practices: Centralized Monitoring" with Datatrak. This FREE webinar will help explain and focus on strategies to assess and implement a greater reliance on centralized monitoring asa defined in the draft FDA guidance on risk-based monitoring.

June 12, 2012

Lorraine Ellis will be part of a panel discussion on "Career Development Pathways Across the Continuum for Clinical Research" planned by SCORE and ACRP at the University of Rochester in Rochester NY.

Additional Information »
April 24, 2012

Lorraine D. Ellis will be speaking at the University of Rochester CTSI Seminar Series on April 24, 2012 12:15pm-1:15pm on the topic of "Monitoring in the 21st century: What the Investigative Site needs to Know".

Additional Information »
MedTech 2012 Annual Conference

Lennox Tech Center, Rochester, NY, on March 13, 2012
Speaker: Lorraine D. Ellis, MS, MBA

Updates on current FDA guidance and regulations will be discussed.

  • 10:30 – 11:30 AM – Draft Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring – Lorraine Ellis
  • 1:00 AM – 2:00 PM – FDA Draft Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices – Lorraine Ellis
MedTech 2011 Annual Conference

September 13th 2011, Rochester NY

Lorraine D. Ellis will be moderating a panel of device regulatory experts that will discuss effects of the pending changes in the 510k program: “Regulatory Trends: 510k Understanding and Preparing for Impending Reform”.

It is part of the MedTech 2011 Annual conference that will be held on Tuesday September 13, 2011 at the Hyatt Hotel in Rochester, NY. Please see the MedTech website for more information.

DIA Annual Meeting

June 21st 2011, Chicago IL

Clinical Operations Track (10 AM Session): “Optimizing Site Performance: Select High Performing Sites, and Diagnose/Repair Poor or Less Experienced Sites”

Presentation: High Performance Sites: Do we select them, build them, or both?
Speaker: Lorraine D. Ellis, MS, MBA

Practical Approaches to Challenging Clinical Trial Collaborations

Held at Roswell Park Cancer Institute, Buffalo NY on March 10, 2011
Speaker: Lorraine D. Ellis, MS, MBA

This presentation provides ideas and tools to increase team cooperation and to improve communication and performance in multiple organization and multiple discipline projects.

Advanced Topics in Good Clinical Practice Symposium

Lennox Tech Center, Rochester, NY, on March 23, 2011
Speaker: Lorraine D. Ellis, MS, MBA

Updates on current FDA guidance and regulations were discussed.

  • FDA Final Guidance Investigator Responsibilities
    (Latest version: October 2009)
  • FDA Inspection of Investigational Sites Guidance
    (Latest version: June 2010)
  • Adverse events: New Regulations (effective March 2011) and Guidance
    (Latest version: September 2010)

For more information or to bring these topics to your organization, contact:
Lorraine Ellis: lellis@resdyncg.com