Laying Down the Ground Rules: Keys to Optimizing Site Management

In order to successfully manage a study there has to be accountability on all levels, internally (study manager), in the field (medical liaison) and at the site (PI). Laying down the ground rules early and setting expectations will help pave the way for success. "People don't plan to fail - they fail to plan."

Robert Friedman, Oncology Medical Development Center, Asst Director, Clinical Development, GLAXOSMITHKLINE

Achieving and Maintaining Investigator Compliance: Sponsors
Partnering with Investigators

Protection of the subject is top priority. The Code of Federal Regulations is clear about a sponsor's responsibilities if serious noncompliance is identified. The Sponsor's goal is to secure and maintain compliance. Proactively building in quality is always the best approach.
How do you avoid having to take extreme measures for noncompliance? What is an approach that can be applied to provide the investigator an opportunity to correct noncompliance? Where do Sponsor's draw the line? What happens when there is serious noncompliance?

Carol Fouts-Johnson, Area Quality Control (AQC) Consultant, ELI LILLY
AND COMPANY

Part 1: Investigator Budgets and Reimbursement: Impact on Site and Investigator Performance

Many in the industry believe change is required as to how site budgets and reimbursement are determined as well as the acceptance and subsequent performance by investigators. Study budgets have continued to decline relative to inflation contributing to increasing numbers of experienced investigators and study coordinators leaving clinical research. This session presents current methods used in formulating site budgets and reimbursement (focus on fair market value) and discusses how they detract or add to investigator performance- with a focus on patient enrollment and retention objectives.

Part 2: Investigator Budgets and Reimbursement: Impact on Site and Investigator Performance

New ideas are presented for planning and formulating study reimbursement budgets. Metrics that clearly show the impact patient recruiting organizations have had on the cost of patients enrolled and retained as well as their effect on site reimbursement are discussed.

Rhoda Mull, JD, Senior Contracts and Finance Specialist,ASTRAZENECA

Scott Jensen, Manager, Global Clinical Budgeting and Contracting, ELI LILLY & CO

Dr. Jeffrey Adelglass, CEO, Research Across America

Moderator: Daniel M. Ulrey, President and Chief Executive Officer, MCSI

Leveraging Sound Grant Payment Practices to Enhance the Sponsor-Site RelationshipKey issues and challenges relating to the delivery of investigator paymentsUsing payments to get more value out of your EDC solutionUnderstanding the potential impact of poor investigator payment practicesAnatomy of a quality grant payment solution 

Kevin T. Williams, MBA/MS, Director of Contracts & Clients Services, Clinical Financial Services, LLC

Investigator Performance PredictionA ground breaking Performance Prediction Scoring Model will  be presented that optimizes the following critical elements of clinical trials execution :·   Identifying the right sites who are treating the right patients per protocol ·   Quantifying target patient capacity of existing sites, new research sites and new potential research physicians ·   Quantifying research experience, competitive research activity, site capabilities etc ·   Optimizing community based resources – physicians, pharmacies and hospitals ·   Actual enrollment Performance Prediction  

Malcolm Bohm, President, TRIALYTICS