Cambridge Healthtech Institute’s Second Annual
Improving Site-Study Activation and Performance
Strategically Implementing a Process for Rapid Study Start-Up
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, 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. Cambridge Healthtech Institute’s Second Annual Improving Site-Study Activation and Performance conference will cover the topics one should consider when strategically implementing a process for rapid study start-up.
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Wednesday, February 25
12:35 pm BRIDGING LUNCHEON PRESENTATION: Optimizing Protocol Planning, Feasibility, and Site Selection through an Integrated View of Clinical Trial Operations and Other Data Sources
Elisa Cascade, President, Hosted Data Solutions, DrugDev.org
As the amount of available data for the support of clinical trial operations continues to expand, organizations are increasingly challenged with the task of integrating these disparate data sources into actionable information. One novel solution to this challenge is DrugDev’sSiteCloud, a platform that offers global users an integrated view of clinical trial operations, clinicaltrials.gov, investigator entered information, and other investigator, site, and protocol level data. In this session, we will discuss available data sources; lessons learned for optimal use of data from Clinical Trial Management Systems (CTMS); and a validated technology solution for virtually matching and visualizing this information within and across companies.
1:25 Chairperson’s Remarks
Greg Cohee, Partner, Pharmica Consulting
1:30 FEATURED CO-PRESENTATION: Creative Trial Designs – How Technology and Digital Medicine Is Changing it All
Debbie Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceuticals Development and Commercialization
Leonard Chuck, M.D., Ph.D., Clinical Investigator, Co-Medical Director, Diablo Clinical Research
Tools and technology are readily available for use in the clinical trial process, from eConsent, to eSource, to digital medicine. How pharma brings these solutions and digital medicine together to improve the clinical trial process and provide data in real time to those who need it, is now at our finger tips. More importantly, what value does this bring to clinical investigators and patients participating in clinical research studies? Diablo Clinical Research and Otsuka have partnered together to revolutionize the clinical trial process by thinking way outside the proverbial pharma R&D box.
2:20 Site Selection Optimization: Using Technology to Harness External and Internal Data to Reduce the Percentage of Non- or Low-Performing Sites
Cindy Levy-Petelinkar, Director, Clinical Platforms Transformation, GlaxoSmithKline
Partnering with Big Data tech companies, GSK is transforming clin ops through enhanced identification of high-performing sites and remediation of inefficiencies such as wastage of investigational product. Data integration from public and GSK-proprietary data sources incorporated into a new platform will address these business processes and include information on disease prevalence, investigators, recruiting, medical facilities, site performance, site data queries, regulatory audits, drug clinical supply manufacturing, shipping and dispensing.
2:45 The Changing Landscape of Site Start-Up Technology
Todd Esporas, Vice President, Study Start-Up and Regulatory, INC Research
The landscape of clinical trial site activation is complex and ever-changing. Focusing on internal process efficiency is not enough to meet the needs of complex, global clinical trials. In such a dynamic environment there is a greater need for visibility for all parties involved – on process, on status and on delivery. Innovation in work flow transparency allows us to set and manage expectations, while creating efficiencies for the multiple stakeholders that are reliant on the information contained within. This innovation must be engineered prior to any study and must be flexible enough to change as the site activation environment continues to evolve.
3:15 Refreshment Break in the Exhibit Hall
4:05 Chairperson’s Remarks
Carol Aliyar, Senior Vice President, Global Head Study Start-Up, INC Research
4:10 TIMI Case Study: Landing a Jumbo Jet: Tools to Help Close Out Large Trials in an Efficient, Orderly and High-Quality Manner
Marc Bonaca, M.D., Cardiologist, Brigham and Women’s Hospital; TIMI Study Group
Considering all of the organizations, data points and processes involved, closing out a trial by completing final patient visits and resolving all data queries accurately and on time is a daunting challenge for any study - especially two global cardiovascular megatrials with more than 18,000 and 20,000 subjects respectively. To accomplish this impressive feat, the TIMI Study Group engaged a technology provider to develop a Closeout Tracker application to track and manage an efficient closeout process. Case studies featuring the global megatrials will be presented.
4:35 Sponsored Presentation (Opportunity Available)
4:50 CO-PRESENTATION: Will CRO Maturation Create Another Link in the Outsourcing Supply Chain?
Adam Chasse, MHA, COO, RxTrials
Eva Kantanas, Director, R&D Procurement, Janssen (invited)
Increased outsourcing combined with rising pressure on CROs to meet timelines cost-effectively is leading to a “tipping point” that will force CROs to redefine their role in the trial management space, particularly as large pharma gives CROs more autonomy within strategic partnerships. While certain core services will still be firmly within the realm of CROs’ internal, CROs will need to consider outsourcing functions that they have not consistently performed well. This creates opportunity for vendors skilled in ancillary areas. It also requires a re-examination of CRO budgets in order to balance lower revenue with increased probability of study success.
5:15 CO-PRESENTATION: SCRS Case Study: Overcoming Hurdles in Study Initiation and Closeout through Collaboration
Christine Pierre, President, The Society for Clinical Research Sites (SCRS)
Dex Bilkic, MBA, Leader, Business Support Group, Boehringer Ingelheim
This presentation will share the commitment and progress The Society for Clinical Research Sites (SCRS) and TransCelerate have made in addressing one of the major areas of study delay – the clinical trials agreement (CTA). You will discover an innovative solution to a major challenge inhibiting study initiation, and learn how the clinical trial landscape is being reshaped by this initiative.
5:40 Reception in the Exhibit Hal
7:00 Close of Day
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Thursday, February 26
7:30 am BREAKFAST PRESENTATION: What’s New in Protocol Feasibility: An Exploration of the Six Key Elements of Data-Driven Feasibility and What Has Changed
Chris Frega, Senior Director, Head, Global Feasibility & Patient Recruitment, Quintiles
Conducting protocol feasibility assessments and developing operational strategies is evolving at an increasingly quick pace to provide better and more robust planning for clinical studies. There is a strong need to include the latest and most relevant data and insights in study planning. This presentation will discuss the essential six elements of protocol feasibility so trial managers can ensure that the critical data is gathered with actionable insights to maximize the potential for operational success of their trial or program.
8:15 Chairperson’s Remarks
Jackie Kent, Senior Director, Clinical Development Information & Optimization(CDIO) & NGD Trial Execution, Eli Lilly & Co.
8:20 CO-PRESENTATION: Utilization of a Recruitment and Retention Specialist in Multi-Site Clinical Trials: Transforming Site Management to Improve Clinical Trial Success
Susan McMahan, Research Nurse and Lead Coordinator, Office for Clinical and Translational Research, Cincinnati Children’s Hospital Medical Center
Stephanie Sullivan, Office for Clinical and Translational Research, Cincinnati Children’s Hospital Medical Center
To achieve enrollment success, trial managers must establish a detailed plan to provide long-term, proactive oversight. This includes close monitoring of site performance, protocol adherence, and recruitment and retention progress. This session will provide information about lessons learned in the MILES Trial, CAE Trial and CHAMP Study and how to effectively anticipate, manage and overcome challenges site performance, recruitment and retention of multi-site clinical trials. Areas to be discussed include planning (funding and written site management plans), education, methods, and monitoring.
8:45 Optimizing Site, CRO, and Sponsor Interactions to Improve Outcomes
Carol Seider, Senior Director, Global Clinical Operations, Clinical Country Management, Biogen Idec
When utilizing a CRO, that CRO represents the sponsor company. How do you optimize up-front planning and processes in order to get the best outcome for all interactions with a site concentrating on a customer-focused approach? This talk will share some common pitfalls and success stories for those interactions and how to provide a path directly to the sponsor company when applicable.
9:10 Sponsored Presentation (Opportunity Available)
9:35 POINT-COUNTER POINT PANEL: Preparing CRAs to be Site Recruitment Managers: The Pros, the Cons and The Process
Beth Harper, President, Consultant, CPP, Inc.
Nikki Christison, Clinical Resolutions, Inc.
Gretchen Goller, Senior Director, Therapeutic Expertise, PRA International
CRAs as site recruitment managers? Absolutely say some. CRAs are key site liaisons and in best position to support site recruitment and retention performance. Others claim this should not be the focus of CRAs whose job is to monitor and ensure protocol and GCP compliance. They claim that CRAs neither have the time nor the skill set to finesse recruitment planning and management discussions with the site. This moderated Point-Counter Point panel discussion will highlight the pros and cons of the role of the CRA as site recruitment manager and discuss process and implementation considerations for setting CRAs to be successful Site Recruitment Managers.
- Insights into how the industry views the role of the CRA as a Site Recruitment Manager
- Considerations for preparing CRAs to play this role
- An understanding of the need to invest in some type of site recruitment oversight to ensure successful delivery of enrollment goals
10:00 Coffee Break in the Exhibit Hall
10:40 Closing Plenary Keynote
1:10 pm SCOPE 2015 Conference Adjourns (see you in Miami for 2016!)
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