2014 Archived Content

 

Cambridge Healthtech Institute’s Inaugural 

Improving Site-Study Activation and Performance 

Optimizing Site, CRO, and Sponsor Interactions
February 5-6, 2014 | Hyatt Regency Miami | Miami, FL 


Clinical trial site activation and efficient study start up are critical to drug development programs, in terms of time, cost and quality of data. In order to improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively in order to improve: the study feasibility process, contract and budget negotiations, standardization of source documents and other study-related materials, development of patient and staff educational materials, and development of patient recruitment and retention programs. CHI’s Inaugural “Improving Site-Study Activation and Performance” will cover the topics one should consider when strategically implementing a process for rapid study start-up.


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WEDNESDAY, FEBRUARY 5 

12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Predicting Enrollment And Building High-Enrolling Sites 

1:20 Chairperson’s Opening Remarks

AdamChasseAdam Chasse, COO, RxTrials





1:30 What Sites Need and Want to be Successful in a World of Increasing Protocol Complexity

AdamChasseBeth Harper, President, Clinical Performance Partners, Inc.

This session will share the results of a meta analysis of site needs assessment surveys conducted by the consultant over 15 years of troubleshooting studies behind in enrollment. By understanding top needs and priorities of sites, sponsors can set them up for study implementation success even if protocol complexity can't be changed.

1:55 Mapping Out Global Enrollment

NyePeltonNye Pelton, Clinical Operations Portfolio Manager, Clinical Research, 
Eli Lilly & Co.

I will present from a sponsor perspective our Global Operations Roadmap, sharing how we make sure all regions are trained, feasibility is provided, and the right countries and patient allocations are submitted back to the study teams prior to Protocol Approval. I will share changes that we have made at Lilly to provide one global voice back to the study teams to implement a plan to enroll our studies in a timely manner.

2:20 The Reward on Investment -How Integrating Your Study Start-Up Processes Yields True Returnepharmasolutions 

LisaLaLunaLisa La Luna, Senior Vice President, Corporate Development & Implementation, ePharmaSolutions

While many sponsors realize they must face the challenges of streamlining study start-up, few have been able to comprehend the true reward on doing do. This session will describe true quantitative impacts observed in doing so.

2:45 Turning Straw into Gold: Creating Centers of Excellence

EllieSmithEllie Smith, Global Clinical Site Developer, Alcon (a Novartis company)

Today’s pharmaceutical landscape is creating a need to reach a greater number of patients needing treatment. And, in answer to this need, sponsors are tasked not only with development of new clinical sites, but also the cultivation of centers of excellence. The following is an examination of the methods used by one sponsor to affect this change.

3:10 Refreshment Break in the Exhibit Hall 


Improve And Measure Sponsor-CRO-Site Interactions 

4:00 Chairperson’s Remarks
Christopher McSpiritt, Principal Consultant, Clinical and Regulatory Optimization, Paragon Solutions 

4:05 Implementing Governance Structures and Processes to Measure and Improve Sponsor-CRO-Site Interactions

SilvanaGiustinoSilvana Giustino, Vice President, Operations, Eisai, Inc.

Implementing governance structures between Sponsors, CROs, and Sites is essential in elevating the partnership to the next level and ensuring mutual benefits are realized in the alliance. Governance structures are aimed to discuss key projects, performance metrics, and innovative solutions which may not be visible on a day-to-day operational level. This session will share real-world examples of this structure and highlight the key benefits.

4:30 Selection and Efficient Negotiation with Your CRO

Elke JordanElke Jordan, Ph.D., Manager, Clinical Development, Bavarian-Nordic GmbH

Identifying critical factors on the CRO and Sponsor side is key in the CRO selection process and project management for a clinical trial. Needs and requirements by the Sponsor on one side, services and capabilities by the CRO on the other side are major objectives in the evaluation process in selecting a CRO for a project. For the success of a project a balanced working relationship between CRO and sponsor is vital. This includes knowledge transfer from Sponsor to CRO and openness to expertise offered by the CRO in mutual discussions besides negotiating distinct milestones to measure the progress and manage a project.

4:55 PANEL: New Frontiers in Collaboration among Key Industry Stakeholders

AdamChasseModerator: Adam Chasse, COO, RxTrials





DeborahManzoDeborah Manzo, Senior Director, Clinical Business Operations & Transformation, Clinical Operations, AbbVie





JamieMacDonaldJamie MacDonald, CEO, INC

 

 

 


 

SilvanaGiustinoSilvana Giustino, Vice President, Operations, Eisai, Inc.

 

 

 

 


 As cost and timeline pressures mount, and strategic alliances become more mature, the traditional pharma/CRO/site model must be re-examined. All three segments must consider how to more effectively allocate resources so that quality and successful delivery is a collaborative effort that begins much earlier in the planning stage for any clinical trial. The panel will discuss potential innovations that may be considered unorthodox when compared to current approaches, but will be essential to the future of the industry.

  • The evolution of dysfunctional and unproductive vendor/client relationships
  • New approaches - breaking down silos and letting go of old methods
  • How dollars and risk might be shifted and how stakeholders must adapt
  • Measuring impact

5:20 Networking Reception in the Exhibit Hall

6:20 End of Day



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