Cambridge Healthtech Institute's 5th Annual

Improving Site-Study Activation and Performance:
( 治験実施施設における臨床研究の始動と実績の改善 )

Strategically Implementing a Process and Systems for Rapid Study Start-Up and Improved Site-CRO-Sponsor Interactions
治験の迅速な立ち上げと実施施設−開発業務受託機関 (CRO) ―治験依頼者間の連携改善に向けたプロセスとシステムの戦略的な導入

2018年2月14-15日 | Hyatt Regency Orlando | フロリダ州オーランド




Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation to be Announced

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine's Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson's Remarks

Shawn Tedman, MBA, Head, Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS

4:05 Site Activation, a Balancing Act between Time and Quality: How to Avoid Paying the Price Later On

Valerie_ReynaertValerie Reynaert, Head, In-Country Clinical Operations for the Americas, R&D Projects Clinical Platform & Sciences, GlaxoSmithKline

There are many processes in the site start up activitities that are redundant, inefficient and needlessly complex. Our study start up timelines often slip as a result. This presentation will share learnings and opportunities on how simplification of our processes and reducing complexity can help in starting up sites on time without paying the price for it later.

4:30 Accelerating Study Start Up: A Centralized Approach

Christina_BrennanChristina Brennan, M.D., Vice President, Clinical Research, Executive Research Administration, Northwell Health

Hospitals and health system consolidations continue to be on the rise and will continue to remake the delivery system landscape over the next 10 years. Clinical research participation will be more efficient if it is approached centrally as a systemwide approach in these settings. Currently, 57% of the US hospitals are part of a system and this will continue to rise. A centralized approach to site selection and site activation will streamline this process and accelerate study start up. This will lead to improved processes with study performance.

4:55 CO-PRESENTATION: Why Is Study Startup Still so Inefficient?

Jae_ChungJae Chung, President & Founder, goBalto

Ken_GetzKen Getz, Director, Sponsored Research Programs, Associate Professor, Tufts CSDD

An in-depth study conducted by Tufts Center for the Study of Drug Development focused on the end-to-end process of site identification through site initiation grapples with this question, and sheds light on the challenges organizations are facing, and on new tools, technologies, and approaches being developed to overcome these hurdles.

5:10 Presentation to be Announced

5:25 PANEL DISCUSSION WITH PATIENT & SITE: Why Site Buy-In Is Crucial to Improving the Trial Participant Experience

Abbe_SteelAbbe Steel, CEO, HealthiVibe, LLC

Patient: Nicole Moore

Bruce_RankinPI: Bruce Rankin, M.D., Avail Clinical (An Accel Research Site)

Chris_HoyleSite: Chris Hoyle, MBA, Executive Director, Elite Research Network

Industry-wide adoption and benchmarking of trial participant insights has the potential to truly improve clinical trial design and execution and improve the patient experience in clinical trials. But the overall success of these surveys is largely dependent on site staff willingness to help implement them at their site. Leveraging sites to implement participant surveys allows the data to quickly grow and reveal a deeper look into the drivers behind what keeps patients coming back. This panel will explore, with site representatives and a patient, the best model for implementation.

  • What are the true hurdles to participation - from the patient perspective?
  • How can pharma do a better job to include sites, and why is this critical?
  • What do site staff (PI, site networks) think about these surveys and the most critical considerations for a successful implementation?

5:50 Close of Day

5:50 - 7:00 pm Track Reception (Sponsorship Opportunity Available)

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation to be Announced


8:30 Chairperson's Remarks

Daniel Piekarz, Senior Vice President, Healthcare & Life Sciences Practice Leader, DataArt

8:35 A Systematic Approach to Study Start-Up: Identifying Risk Factors and KPIs to Ensure Faster Start-Up and Better Accrual Rates

Marina_MalikovaMarina Malikova, Ph.D., Executive Director, Surgery, Boston University Medical Center

The success of a trial heavily relies on the strong bond between trial operations and project management throughout the life cycle of the trial. It is important to develop a specific knowledge of the strengths, weaknesses and pitfalls of assumed risks at the inception of the project in order to devise a solid strategy to mitigate them throughout implementation phase. Systematic assessment of risk factors and key performance indicators at a start-up phase can allow for more efficient execution of a clinical trial and ensure better accrual rates. This session will discuss best practices to expedite start-up phase.

9:00 CO-PRESENTATION: How Reg Ops and Clin Ops Business Integration Can Accelerate Timelines to Submission

Sophia_KourliourosSophia Kourliouros, Senior Manager, Global Regulatory Operations, Eisai, Inc.

Speaker to be Announced, Clinical Operations, Eisai, Inc.

This presentation will be given from a Regulatory Operations perspective to provide best practices to the Clinical Operations team when submitting clinical documents. In order to make submissions faster and ensure the quality of the data, it's important to include RegOps in your planning, business process strategy and operations. This talk will provide best practices to help colleagues in Clinical Operations work more efficiently with their RegOps team to improve business process and study start-up.

9:25 CASE STUDY: Transforming the Site Monitoring and Management Model to Become a Sponsor of Choice for Sites and Improve Quality

Mark_RidgeMark Ridge, Vice President, Clinical Development Operations, CSL Behring

This session will explore an innovative site management and oversight approach to transform site relationships, enhance site quality and strengthen the overall site monitoring approach that yields successful approval of new therapies for patients. The presentation will include site survey results and lessons learned.

9:50 Partnering Shared Expertise and Technology to Optimize Study Planning

Loni_BranonLoni Branon, Director, Sitetrove/Chinatrove, Pharma Intelligence-Informa

While navigating the rough seas toward study activation, advanced planning is key to staying on course. Our presenters will share insights on streamlining the study start up journey, by addressing major components such as protocol development, competitive landscape assessment, evaluating patient demand and country/site selection. We'll touch on how combining expertise with a trusted crew, along with a few simple tech tools, will ensure smooth sailing and a timely arrival at your final destination.

10:15 Networking Coffee Break


10:30 Chairperson's Remarks

10:35 PANEL DISCUSSION: eConsent after the Pilot: Implementation Lessons Learned by Study Experts

Eric_DelenteEric Delente, President, Patient Solutions, DrugDev

Scott_AskinScott Askin, Digital Development Director, Lead for eSource and eICF, Digital Development, Portfolio, Strategy & Innovation (PS&I), Novartis Pharma

Jennifer_LentzJennifer Lentz, Consultant, Global Informed Consent Business Lead, Global Clinical Operations, Eli Lilly and Company; member of TransCelerate eConsent Initiative

eConsent (eICF) is a potential participant's first real interaction as they consider participation in a clinical trial, and as such, it can be the keystone of a patient engagement strategy. Different sets of challenges and solutions appear at each stage as the implementation moves beyond early stages. In this panel-led discussion, we'll hear perspectives from experts that start with using eICF in a pilot, then move into regulatory and quality considerations with perspectives, and finally the challenges of broader, global implementations. This discussion will also reveal some of the reasons why use of eConsent is not yet ubiquitous across the industry. The panel will include an interactive discussion, driven by questions from attendees with a goal of illuminating the path beyond pilot implementations, and attendees' understanding of how an eConsent program can improve patient engagement.

  • Understand the benefits and potential role of eConsent in Patient Engagement
  • Recognize challenges of eConsent adoption across various stages of implementation from several perspectives
  • Discuss potential approaches to implementation

11:00 Sponsored Presentation (Opportunity Available)

11:25 Transition to Shared Session


11:35 Digital Trends Impacting Recruitment, Engagement and Retention

Shwen GweeShwen Gwee, Head of Digital Strategy, Global Clinical Operations, Biogen

Digital technology is connecting more people to clinical trials than ever before, and at the same time, the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technologies and approaches are having the greatest impact on recruitment, engagement and retention?

12:00 pm CASE STUDY: The Art and Science of Patient Engagement in the Digital Era - Learning from GSK PARADE Study

Michelle_CrouthamelMichelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline

The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Although the emerging mHealth technologies have the potential to improve the conduct of clinical trials, the successful implementation requires careful study design and patient engagement. Data and experiences from GSK PARADE study will be summarized, highlighting the learning and opportunities in this new area of clinical development.

12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation Initiative

Hassan_KadhimHassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim Pharmaceuticals

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?

Jim_KremidasJim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)

David_VulcanoDavid Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)

Sean_WalshSean Walsh, MBA, Chief Development Officer, Raleigh Neurology Associates

Beth_HarperBeth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites' needs?

  • Share sites' perspective on the evolving clinical research landscape
  • Discuss the reasons sites struggle with new processes and technology tools
  • Determine ways to facilitate adoption

1:15 Closing Remarks

1:20 SCOPE Summit 2018 Adjourns

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


2018 SCOPE Conference at a Glance

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)