Pre-Conference Workshop Day – Monday, March 19, 2012
12:00 PM Registration Opens
1:00 PM Pre-Conference Workshop
Site Contracts, Activation, Delays And Timelines

Led By:
Deena Bernstein, Director, Clinical Research, Sheridan Clinical Research, Inc.

David Knepper, MS, MBA, Head Of Continuous Improvement, Forest Laboratories

Thomas D. Meulbroek, J.D., Associate Consultant, Contracts Management, Lilly
5:00 PM Workshop Concludes

 

Day One – Tuesday, March 20, 2012
8:00 AM Registration Opens and Continental Breakfast
9:00 AM Chairperson’s Welcome and Opening Remarks

Kelly M Willenberg, MBA, BSN, CHC, CHRC, President, Synergism, LLC
9:15 AM Changing Site Selection Requirements: How New Guidance And Ema Inspections Are Changing How Sites Are Selected

David Knepper, MS, MBA, Head Of Continuous Improvement, Forest Laboratories
10:00 AM Using Technology and EHR Data to Accelerate and Improve Site Selection

Lisa La Luna, SVP of Corporate Implementation, ePharmaSolutions
10:45 AM Networking & Refreshment Break
11:15 AM Panel Discussion: Streamlining Activation Through Proper Planning For IRB Requirements

Panelists:
Lynn Meyer, President, Integreview Ethical Review Board

Dr. Joan Shapiro, Associate Dean For Research, University Of Arizona College Of Medicine, Phoenix

Sharon R. O’Brien, Regulatory Associate, Penn State Hershey Medical Center
12:00 PM Clinical Trial Training: Investigator, Delegate And Sponsor Responsibility

Pamela Nelson, RN MS, President/CEO, Bracane Company
12:45 PM Lunch
1:45 PM Panel Discussion: How Trial Budgets And Standard-Of-Care Impact CRO’s, Sites And Sponsors During Negotiations

Moderator:
Kelly M Willenberg, MBA, BSN, CHC, CHRC, President, Synergism, LLC

Panelists:
Deena Bernstein, Director, Clinical Research, Sheridan Clinical Research, Inc.

Allison Burmeister, MBA, Sr. Analyst, Clinical Business Operations, Janssen AI R&D, LLC
2:30 PM “New” Sites And “New” Investigators, How Do You Choose Them?

Kerri Mallory, Site Development Manager, Glaxosmithkline (Biologicals) Vaccines
3:15 PM Networking & Refreshment Break
3:45 PM How Sites Can Leverage EHR Data For Site Startup And Associated Implications For Sponsor And CROs

Christy Gilchrist, PhD, CRA, Health Director Of Research, Wellspan

Todd Tullis, Senior Director of Product Management, GoBalto
4:30 PM Non-Physician Provider as Principal Investigator – A Change in Tradition not Guidelines

Nancy K. Durham, MSN, APRN, C-FNP, CDE, President and Chief Clinician, Mountain View Clinical Research
5:15 PM Close of Day One
Cocktail Reception Sponsored By:

 

Day Two – Wednesday, March 21, 2012
8:00 AM

Continental Breakfast Opens
8:45 AM Chairperson’S Day One Recap

Kelly M Willenberg, MBA, BSN, CHC, CHRC, President, Synergism, LLC
9:00 AM A Private Investigator’S Perspective On Selection And Start-Up – What Are The Roadblocks Investigators Are Facing When Conducting Industry Sponsored Research?

Cristina Truica Md, Associate Professor Of Medicine, Penn State
College Of Medicine, Director, Breast Medical Oncology, Penn State Hershey Cancer Institute
9:45 AM Case Study: Mitigating Risks And Variance When Budgeting And Contracting For A Complex Global Clinical Trial

Allison Burmeister, MBA, Sr. Analyst, Clinical Business Operations, Janssen AI R&D, LLC
10:45 AM Networking & Refreshment Break
11:15 AM How To Motivate Your Sites To Increase Study Enrollment

Dr. Joan Rankin Shapiro, MD, Ph.D, Associate Dean For Research, University Of Arizona College Of Medicine, Phoenix
12:00 PM Case Study: Determining The Viability For Clinical Trial Success At The Site Level

Damon R. Michaels, CCRP, Director – Clinical Trials Research Department Of Anesthesiology, Vanderbilt University Medical Center
12:45 PM Lunch
1:45 PM Applying Quality Risk Management in Clinical Trials and Site Feasibility

Ken Schiff, President/Owner, Quality Risk Management Associates, LLC
2:30 PM Building Productive Sponsor – CRO Relationships

Chris Hoyle, MBA, Executive Director, Elite Research Network
3:15 PM Conference Concludes