Clinical Protocol Development Track 

Virtual Investigator Meeting Management Track 

Clinical Training Forum Track 

Clinical Project Management Forum Track 


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2012 CTD Barnett's Clinical Summit Brochure
2012 Final Brochure

Barnett International & Cambridge Healthtech Institute's Inaugural
Virtual Investigator Meeting Management
Impact Trial Outcomes through Strategic Investigator Meeting Planning 

October 9-10, 2012 

 

Day 1 | Day 2 | Download Brochure 

It has been argued that investigator meetings are at the heart of clinical trials--the success of a study depends on them. Investigator meetings are quite involved to organize, and costs can easily skyrocket out of control. There is also some debate about how well information retention can be achieved in such short periods of time, and whether or not it makes more sense to offer content in “segments,” so that better adult learning practices can be built in to content and program design. Web-based meetings offer huge cost and time savings, help with quality, and given people’s schedules and travel considerations, it can be argued that virtual investigator meetings are the platform of choice for many investigators. At Barnett/ CHI’s Inaugural Virtual Investigator Meeting Management forum, stakeholders in the investigator meeting management, clinical operations and compliance arenas will come together to discuss strategies to optimize the investigator meeting through virtual meeting platforms.

Tuesday, October 9, 2012

8:15am Main Conference Registration and Morning Coffee

8:45 Barnett Welcome and Introductions

8:50 Chairperson’s Welcome and Opening Remarks


Virtual Investigator Meeting Decision-Making 

9:00 Optimizing Study Start Up Timelines with Virtual Meetings Initiatives

Lori Vivian, Director, Clinical Research Operations, Syntactx

Time is money. When starting up a study, whether for support of a PMA, NDA, or even post marking, shortening the timeline of site NDA completion to their first subject enrolled is imperative. The use of virtual investigator meetings or even site initiation meetings in the right setting can assuredly speed up the process, shortening the time to submission and approval or clearance. This presentation will review the benefits of using virtual meetings, including when they are appropriate for particular studies, and how to present them successfully.

9:45 Takeda’s Experience with Planning and Conducting Virtual Investigator Meetings

Sarah Tsymbalov, MS, Program Manager, Clinical Operations, Takeda Global Research & Development

Teams are often asked to develop innovative ways of improving existing processes to make them more efficient from a time and cost perspective. Transition of F2F to Virtual investigator meetings is just one such example. This non traditional method of planning and conducting virtual IMs was explored by a team managing a large CV Outcomes trial. This presentation will focus on the logistics and best practices utilized and will describe the “Decision Tree” used to assist the decision process of utilizing the virtual platform vs. the traditional F2F platform. In addition, we will explore ways to keep participants engaged and focused on the content without the hassle of travel. Finally, we will review the current practice utilized by study team which includes the use of pre-training modules.

10:30 Coffee Break

11:00 Using a Blended Meeting Strategy to Accelerate Study Site Start Up

Denise Finley, Director, Clinical Learning and Development, Boston Scientific

Hear a case study on how one sponsor uses blended learning solutions for investigator responsibility and protocol-specific training for less complex clinical trials. Included are the pros and cons of the approach, including how site start-up issues such as scheduling, training, changes in personnel and other factors can be minimized.

11:45 Sponsored Presentation (Opportunity Available; contact Ilana Quigley, iquigley@healthtech.com)

12:00 Luncheon Presentation (Opportunity Available; contact Ilana Quigley, iquigley@healthtech.com) or Lunch on Your Own

Blended Learning Approaches to Investigator Meetings

1:15 Review of 10 Blended Learning Techniques, Including How They May Contribute to a Site’s Understanding of and Compliance with the Protocol

Julie Kernis, Associate Director, Global Training, ePharmaSolutions

In this session, participants will be presented with and discuss 10 learning solutions that clinical teams can make available to site staff throughout the trial. The solutions may be applied to study start-up, staffing changes, newly selected sites/countries/regions, protocol amendment training gaps, protocol version training gaps, introduction of new tools while the study is ongoing, one-on-one question and answer sessions, information refreshers, and site-directed learning needs. The 10 learning techniques that will be discussed include 1) face-to-face group training; 2) webinars; 3) virtual classrooms; 4) one-on-one training; 5) basic online training modules; 6) scenario-based assessments; 7) software simulations; 8) archives of group learning; 9) mediated social forums; and 10) wikis. For each of the 10 learning techniques, implementation considerations will be discussed, including recommended application of each solution, supporting tools and technology, staffing, and potential risks.

Trial timeline, tools to consider for supporting these learning techniques, potential roles needed to make the training method successful, and risks associated with implementing each technique will also be reviewed. A hand-out outlining this information will be provided to participants.

2:00 Designing Synchronous Learning - Creating Virtual Learning Programs that Make an Impact

Jennifer Hofmann, President, InSync Training

This session discusses and explores the concerns that many training professionals have: how to keep participants engaged and active in the online environment so that the learning outcome is of the same quality as a classroom-based delivery. The session focuses on what the instructional designer can do via the design process in order to alleviate the Facilitator’s concerns and provide a quality learning experience for the participants. The design concepts addressed in this session include:

  • Interaction vs. collaboration
  • Concurrent and serial collaboration
  • Uses for interaction vs. collaboration
  • Best practices for designing synchronous exercises for the following collaborative tools: breakout rooms, whiteboard, chat, synchronized web browsing, and application sharing

2:45 Challenging Conventional Wisdom in Virtual Investigator Meetings

Steven Sulkin, Founder & CEO, MBM Productions International

There is much conventional wisdom that the virtual investigator meetings industry follows, but do the metrics support what have become the common approaches? The presenter will challenge some of these conventional wisdoms, not just by talk but through the examples of a variety of types of virtual meeting case studies. Specifically covered are benefits and disadvantages of live vs. recorded meetings, including the risks involved around human error and compliance. Also explored are ways that interactivity can be maintained in a variety of settings including the technologies that support best practices. In the end, the audience can decide what works and what doesn’t and how we can collectively work toward cementing virtual investigator meetings as a truly viable meeting platform.

3:30 Refreshment Break with Exhibit Viewing



Technology Vendor Showcase
 

4:00 Vendor Town Hall

This unique Vendor Town Hall will provide attendees with an understanding of how to select and optimize vendor relationships for Virtual Meetings support. Hear vendor perspectives on virtual meetings approaches that maximize investigator participation and learning. Attendees will walk away from the session with a checklist of key vendor selection criteria, including the variables associated with different technology options and options for blended learning solutions.

5:30 Welcome Reception with Exhibit Viewing



Day 1 | Day 2 | Download Brochure 



 
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