Improving Site-Study Activation and Performance

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 Third 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.

Arrive early and attend Part 1: Global Site Selection
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies | Download Brochure

Wednesday, February 24

12:10 pm Bridging Luncheon Presentation: Predicting Success of an Unknown Site: The Science of Quantifying Performance Opportunity of New Sites

Lewis_AprilApril Lewis, Head, Product Education, Clinical Trial Optimization Solutions, IMS Health

For those sites with whom a Sponsor or CRO has experience, past performance can be a critical predictor of future performance. But how is site performance potential evaluated on new sites where this information does not exist? This presentation will provide details on a comprehensive analysis performed utilizing site level recruitment patterns, detailed site demographics, and site level claims data to determine the factors that predict site performance in the absence of history or experience.

12:50 Coffee and Dessert in the Exhibit Hall

1:30 Plenary Keynotes - View Details

3:00 Refreshment Break in the Exhibit Hall (Last Chance for Viewing)


4:00 Chairperson’s Remarks

Giustino_SilvanaSilvana Giustino, Global Head, Clinical Development Expert Resources, Roche

4:05 CO-PRESENTATION: The Social Experiment: Deep Team Integration with Sites and Providers Results in a Successful Study Launch

BeVard_DeirdreDeirdre BeVard, Vice President, Development Operations, Nektar Therapeutics

Daniel_EileenEileen Daniel, Executive Director, Clinical Operations, Nektar Therapeutics

They laughed, they cried, they collaborated! Working as an integrated team with sites and providers is real partnering with real benefit, and it takes real effort. Deirdre BeVard and Eileen Daniel will share recent experience launching a Phase 3 program employing unconventional approaches for study team formation and early site interaction, and a deliberately metered start-up. They will share what really happened along the way and how it shaped the operations and team relationships.

4:30 Integrating TMF and Clinical Processes to Improve Study Operations

King_KathrynKathryn King, Ph.D., Vice President, Vault Clinical, Veeva Systems

When TMF processes are integrated and aligned with other clinical development processes through an eTMF, it helps enable a real-time and inspection-ready TMF. It also provides a lens to review and optimize study operations. In this session, we will discuss the improvements that can be made when moving from an archive to an active TMF that can manage workflows and processes. Topics will include metrics and reporting, the importance of using a common language (TMF Reference Model), and collaboration with external partners.

4:55 CO-PRESENTATION Case Study: C-Diff Recruitment Challenges and How We Put the Brown in Jean Brown Research! Site and Sponsor Collaboration to Achieve Success

Christoff_JanetJanet Christoff, Clinical Trial Manager, Study Management and Logistics, Sanofi Pasteur

Minoughan_CarolCarol Minoughan, Vaccine Project Manager, Jean Brown Research

This presentation will share the story of the challenges faced by both sponsor and site to recruit, and manage a global Cdifficile prevention trial. What are the current enrollment tactics and what strategies have been employed to mobilize and renew site motivation and patient interest. What specific issues has the sponsor faced in onboarding sites of excellence? What specific issues has the site faced in finding and keeping subjects in the trial? What impact has nurturing the site/sponsor relationship had on building momentum for success? What processes and assumptions had to be reassessed?

5:20 Mitigating Clinical Trial Risk and Operational Cycle Times through Cloud Based Workflow Technologies

Milton_BarryBarry Milton, Director, Pre-Sales, goBalto, Inc.

Given society’s growing insistence on faster drug development, an improved SSU process, enabled by cloud-based technology, aligns with that goal by significantly impacting cycle times in clinical trials. This leads to faster access for patients resulting in greater cost savings and faster market entry, making valuable therapies available to more patients sooner.

5:35 CASE STUDY: How Patient Engagement in Mobile Medical Technology is Transforming the Clinical Research Arena

Cruz_MiriamMiriam Cruz, Head, Clinical Operations, Proteus Digital Health, Inc.

As medical technology evolves and becomes widely accepted in investigating and monitoring patient medical data, rapid access to data and simple interpretable data views, proper introduction of new medical technology to subjects is becoming essential. In this talk I will review a successful approach to introducing medical technology in a broad spectrum of subjects. Our key to success included a clear understanding of the impact of different factors such as familiarity with mobile technology alongside language and age barriers.

5:45 Close of Day

Arrive early and attend Part 1: Global Site Selection
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies | Download Brochure

Thursday, February 25

7:15 am Registration

7:45 Breakfast Presentation: How One (Golden) Number Can Transform Clinical Trials

Stephenson_HugoHugo Stephenson, M.D., Chairman, DrugDev


8:35 Chairperson’s Remarks

Cruz_MiriamMiriam Cruz, Head, Clinical Operations, Proteus Digital Health, Inc.

8:40 Optimizing the Site Experience in the Era of Patient-Centric Trials

Carol SeiderCarol Seider, Senior Director, Global Clinical Operations, Biogen

As companies refine their overall focus to a limited number of therapeutic areas or disease entities and plan for more than one product in those areas, it is critical to partner with clinical research sites who are experts in those fields of study and gain insight from the patients who experience those diseases. Robust working relationships with sites should be established and maintained throughout the clinical research process and sites should not only participate in more than one trial but also be asked for input into operational design and activities.

9:05 CTA Adoption Case Study: Collaboration to Simplify Research and Processes to Benefit Sponsors, Sites and Patients

Bilkic_DexDex Bilkic, MBA, Leader, Business Support Group, Boehringer Ingelheim

There are many processes in clin research that are redundant, inefficient and needlessly complex. There are also a number of opportunities to be exploited by industry especially in areas where simplification of our processes can speed up research and development of new medicines. To achieve this, all the stakeholders need to work together. This presentation will share progress The Society for Clinical Research Sites (SCRS) and TransCelerate have made in addressing one of the major areas of study delay – the CTA. This initiative presents a solution to a challenge inhibiting study initiation, and showcases that collaboration, courage and trust can reshape the trial landscape.

9:30 CO-PRESENTATION: Creating a Culture of Quality in Your Organization: New Ideas for Compliance Management

Guattery_DeborahDeborah Guattery, Quality Systems, CAPA Manager, Clinical Quality Control and Compliance, CSL Behring

Kuss_SheriSheri Kuss, Quality and Compliance Manager, Clinical Quality Control & Compliance, Clinical Operations, CSL Behring

This presentation will provide information about how we at CSL Behring formed a quality compliance group within clinical operations. The mission of this team is to increase compliance to sponsor protocol, SOPs and regulations by applying risk management and Quality by Design (QbD) principles to the actions of the team and infusing these into the study operational teams. The audience will gain insight into how infusing and creating a quality culture is achievable.

9:55 Advances in Feasibility Study Technology: Accurately Predict Enrollment Rates, Identify Problem Areas Sooner with the EnForeSys® Simulation Software

Speaker to be Announced

Will your trial recruit as planned and start on time? How certain are you? Cytel’s EnForeSys®software reveals the likely impact of trade-offs and determine the enrollment plan most likely to succeed. You’ll learn to: Align study team members on the range of input parameters to yield accurate simulations; Best apply simulation results for improved planning; Move beyond stakeholder’s individual beliefs and toward truly objective assessments of an enrollment plan’s feasibility.

10:20 Coffee Break


Special Shared Session

10:35 Chairperson’s Remarks

Leventhal_DavidDavid Leventhal, Director, Clinical Innovation, Worldwide Research & Development, Pfizer

10:40 The Challenges and Solutions on Achieving True Patient Centricity: The Site’s Perspective from a Data Exchange, Study Design, Technology and Personal Perspective

Pierre_ChristineChristine Pierre, Founder and President, Society for Clinical Research Sites (SCRS)

As sites we are privileged and responsible for providing the “personal touch” between the clinical trial and the patients. This unique relationship provides invaluable information for industry stakeholders to gain first hand knowledge of the realities of the study experience and it’s impact on truly making the clinical trials a patient centric experience. Data and perspective will be shared regarding the impact of lack of data exchange, study design, technology and more will be discussed in a lively session aimed at making patient centricity a reality and not a phrase.

11:05 Sponsored Presentation
Speaker to be Announced, Worldwide Clinical Trials

11:30 CO-PRESENTATION: Integrating Data Science into Clinical Trial Planning and Operations

Profit_DebbieDebbie Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceuticals Development and Commercialization

Shashank_RohatagiShashank Rohatagi, Ph.D., Senior Director, Translational Medicine & Think Team, Otsuka Pharmaceuticals Development and Commercialization

The use of technology in the support of clinical trials has continued to increase. However, the disciplines and departments remain very distinct and in some cases siloed. In order to gain the most from your data, to make better decisions based on the data, to formulate more effective trial strategy, and to improve trial operations processes, there must be a more fluid interchange between the data scientists and trial planners.

11:55 Implementing a Patient Centricity Platform to Better Engage Patients and Sites in Informed Consent Process

Allen_RobertRobert Allen, Senior Director, Digital Innovation Group (DIG), AstraZeneca

Often we forget the human-side of a clinical trial. With trial design, protocol development, and clinical data as primary concerns, we forget engaging patients and investigators is just as important. Engagement can lead to a greater understanding of the trial with the hopes of making the experiences better for everyone. This talk will focus on striking the balance between creating trial effectiveness and efficiency through technology, while putting humans at the center through a use case of implementing the Patient Centricity platform to engage patients better in informed consent process.

12:20 INTERACTIVE PANEL: Can We Shift Investigators from “1 and Done” to Repeat Performers

Sears_ClaireClaire Sears, Ph.D., Director, Investigator Engagement, SiteStart, DrugDev

Getz_KenKen Getz, Tufts University Center for Drug Development

Pierre_ChristineChristine Pierre, Founder & President, Society for Clinical Research Sites (SCRS)

In this session we will discuss the problem of investigator turnover – in particular, the large ‘1 and done’ population. Tufts will present information from the FDA 1572 database on the trends, characteristics and size of the ‘1 and done’ population. This information will be supplemented by a presentation of findings from the Investigator Databank related to characteristics of approximately 70,000 ‘1 and done’ sites including site level performance amongst other factors (e.g., geography, pediatrics, therapeutic area). It is clear that the high rate of attrition of investigators and the need to initiate new investigators is detrimental to site and overall trial performance, and is costly and time-consuming for sponsors. The session will conclude with a commentary on the data from the Site perspective regarding what can be done (if anything) to decrease the rate of investigator turnover. The learning objectives for this session are:

  • Learn detailed characteristics of the global population of investigators who have only participated in one clinical trial
  • Identify factors that can be gleaned from these detailed analyses that help identify investigators at risk of only participating in a single clinical trial
  • Based on these insights, discuss strategies/actions that can help reduce the likelihood of future site turnover

12:45 Closing Remarks

12:50 pm SCOPE 2016 Conference Adjourns (see you back in Miami in 2017!)

Arrive early and attend Part 1: Global Site Selection
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies | Download Brochure

Suggested Event Package*

2:00 – 5:30 pm SC1: Implementing Social Media, Digital Marketing and Other New Strategies for Patient Recruitment* - Detailed Agenda

February 23-24: Global Site Selection, Feasibility Assessment, Operations and Site Management Conference

February 24-25: Improving Site-Study Activation and Performance Conference

* Separate registration required

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