Clinical Protocol Development Track 

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 Day 1  |  Day 2 | Download Conference Brochure | Short Courses 

TUESDAY, OCTOBER 4, 2011

7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

 

OPTIMIZING SITE SELECTION AND
SETTING YOUR SITES UP FOR SUCCESS (cont.)
 

8:25 Chairperson’s Opening Remarks

Richard Robinson, Associate Director Program Management, Quest Diagnostics; Former Assistant Director, Internal Medicine, US Clinical Research, sanofi-aventis Group

8:30 Case Study: Improving Clinical Site Validation and Predictability

Christopher Conklin, Manager, Global Trial Optimization, Global Trial Management, Merck & Co.

This presentation will explore the site validation Process at Merck, and the success of that process in terms of site enrollment predictability. An overview of a Sigma (process improvement) project aimed at improving the predictability of site enrollment estimates will be given, and findings and enhancements to the process as a result will be discussed. If available, results from a pilot of the enhanced process will be shared. The audience could potentially gain a new approach to site validation/selection or practical tools to improve their existing process.

9:00 Managing Site Performance and Delivery: Why What Works With Your Own Staff Won't Work With Your Sites

Adam ChasseAdam Chasse, Vice President, Corporate Development, RxTrials 

You've analyzed sites' past performance and all the feasibility data, picked your sites carefully, and contracted with a vendor or two that will help the sites identify patients, all of which will ensure that your study will buck the 10-year trend of 30% of sites enrolling most of your patients... right? While these techniques are necessary pieces of the puzzle, they presuppose that sites plan and manage their studies with the same rigor that your company does. Most sites, however, do not - and there are no statistical or technological solutions that will fully solve this problem. This session will focus on how industry must tailor its solutions such that busy healthcare providers – for whom research is a very small part of their professional activities – can develop and execute robust strategies to deliver studies on time.

9:30 Optimizing Site Selection: A Case Study from a Global Phase III Clinical Trial

Franco DaviFranco Davi, Senior Clinical Manager, Oncology Global Development, Novartis Oncology

This presentation will discuss how to select sites and who to involve in the site selection process. Feasibility is a key step in determining the right sites for a particular trial. We must be efficient and effective in selecting sites so that enrollment into the trial can be completed in as short an amount of time as possible. Relationships between the sponsor and site or CRO and site must be strong so that the study is always kept top of mind at the site. The key objective of the involvement of personnel is to make sure everyone is kept in the loop prior to sites being activated in order to not delay any start-up timelines set for the study.

10:00 Networking Coffee Break in Exhibit Hall

10:45 Case Study: New Process and Metric for Determining Site Quality

Lorne CheesemanLorne Cheeseman, Former Senior Director, North America, Site Management and Monitoring, Allergan, Inc.





 

11:15 Critical Success Factors that Contribute to Optimal Site Performance in an Academic Center: Lessons Learned

Marcellina OparaojiMarcellina Oparaoji, Ed.D., CCRP, Executive Director, Clinical Research Operations, Office of Research, Drexel University College of Medicine

Relationships between academia and industry present special challenges. As it appears, the missions and goals differ. These differences and challenges pose the questions that follow: How do academic institutions manage academia-industry relationships? How can institutions and companies manage these differences? How will universities and companies measure success in their relationships? This session will focus on five critical factors that contribute greatly to such success, from lessons learned. We intend to define what optimal site performance is, what gets in the way of achieving it and the critical success factors that enable it. Critical factors like well managed expectations with careful planning; team communication; role-based training; commitment to performance measurement and improvement; and managing change, are considered. At the end of the session, participants will come away with practical steps that can be carried out, and why carrying out these steps may well be the major breakthrough in improving teams from good to great, for the benefit of parties involved!

11:45 Sponsored Presenation (Opportunity Available)

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

SITE RELATIONSHIP MANAGEMENT TECHNIQUES 

1:25 Chairperson’s Remarks

Christopher Conklin, Manager, Global Trial Optimization, Global Trial Management, Merck & Co.

1:30 Providing Study Sites Objective Feedback through the Study Activity Report

Richard RobinsonRichard Robinson, Associate Director Program Management, Quest Diagnostics; Former Assistant Director, Internal Medicine, US Clinical Research, sanofi-aventis Group

This presentation will evaluate the use of Study Activity Reports to provide objective feedback to investigative sites in comparison to their peers on a specific trial. Discussions will focus on identifying Key Performance Indicators (KPIs) that are important to you as a sponsor and valuable to sites in the evaluation of their individual performance and areas needing improvement. Examples of the Study Activity Report will be reviewed, as well as feedback from sites. Some key issues to be discussed include: Sponsors collect, track, and analyze site performance data on a constant basis, how often do they provide these feedback to their sites? Can utilizing objective performance metrics enhance the Sponsor-Site relationship? How can you expect a site to perform better if you don’t know where or how it needs to improve?

2:00 Understanding the Data: Global Investigative Sites Measuring Their Relationships with Sponsors and CROs

Joan ChambersJoan Chambers, COO, CenterWatch

It is a well-known industry fact that sponsors and CROs evaluate investigative sites after conducting and managing their clinical studies along with developing “report cards” on the site’s performance. CenterWatch conducted a 2011 survey of global investigative sites on their business relationships with sponsors and CROs and asking who they felt were the top companies to work with within the clinical trials industry.

2:30 Networking Refreshment Break in the Exhibit Hall

 

ISSUES MANAGEMENT AND STRATEGIES
FOR MAINTAINING PERFORMANCE
 

3:15 Monitor Perspective: Communication Strategies for Establishing Clear Expectations and Providing Timely Feedback to Sites

Kristopher ChrismanKristopher Chrisman, CCRP, Senior CRA, Metabolism & Diabetes/Internal Medicine, US Clinical Research, sanofi-aventis

This presentation will focus in concrete terms on understanding the importance of fluid communication between the Sponsor or CRO (specifically the CRA as the face of the Sponsor) and the Study Site as it relates to the success of the clinical trial for both sides. Discussions will focus on identifying general rules to effective feedback, establishing a clear line of contact and understanding the potential benefits for the Site and the Sponsor as a result of site management utilizing an open line of communication.

3:45 How to Support the CRA as a Manager of Site Performance in the Conduct of Complex Clinical Trials

Christopher BeardmoreChristopher Beardmore, President and CEO, Oncology, Translational Research Management, LLC

Comparative effectiveness research and the move toward personalized medicine require Clinical Research Associates to assume a leadership role in the conduct of complex clinical trials. With increased responsibility for resourcing, attention to timeliness metrics (contract signed on time, FPFV on time, patient recruitment and CRF progress) and quality, CRAs require support and a new set of tools to effectively assume the role of site manager. The presentation will present metrics to determine CRA knowledge, skills and abilities, offer tools to assess quality and provide ways sites can best support CRAs as they take on this vital research role.

4:15 Topic to be Announced  

4:45 Closing Remarks

5:00 End of Site Performance Management

 

Stay on for Clinical Project Management and Clinical Training Forum (October 5-6) 

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