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.

Wednesday, February 24

12:10 pm Bridging Luncheon Presentation: Real World Data in Clinical Trial Planning: Game Changer?

Bernadette CollinsBernadette Collins, Senior Manager, Data Services, Clinical Trial Optimization Solutions, IMS Health

April LewisApril Lewis, Head, Clinical Trial Optimization Solutions, IMS Health

IMS Health is the world’s largest purveyor of healthcare data. Over the past few years, we have developed a team of experts dedicated to evaluating the most influential assets to support trial feasibility and increased success in site selection and trial planning. In this session our experts will review what type of global assets are obtainable, how these assets can validate and substantiate trial planning decisions. Practical examples will be shared and case studies will be reviewed.

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

Methia_JasonJason Methia, MS, Director, Vault eTMF Strategy, 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 Case Study: C-Diff Recruitment Challenges and How We Put the Brown in Jean Brown Research! Site and Sponsor Collaboration to Achieve Success

Denise_RobertsDenise Roberts, President, 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.

5:45 Close of Day

Thursday, February 25

7:15 am Registration

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

Elisa_CascadeElisa Cascade, MBA, President, Data Solutions, DrugDev

For years pharmaceutical companies and CROs have struggled to collect, clean and collate site data from disparate sources so they can make better decisions about site feasibility and selection. With the DrugDev Golden Number - a universal identifier for Investigators and sites - individual pharma companies and CROs easily match and master data, and share data across collaborations like the Investigator Databank and TransCelerate. While the Golden Number began as a method for data sharing, innovators are using it to drive operational efficiencies, collaboration and integrated reporting as well. We expect it also will give regulators a more detailed view into the global investigator community, which ultimately can improve patient safety. Join this session for a discussion on the Golden Number and how it can help pharma, CROs and sites do more trials.


8:35 Chairperson’s Remarks

Robert_LollRobert Loll, Vice President, Business Development & Strategic Planning, Praxis

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

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

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, Associate Director, Clinical Process Development, Teva Pharmaceuticals

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

Charles LiuCharles Liu, Statistician, Product Marketing, Software Development, Cytel

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.

Worldwide Clinical Trials11:05 Rebuilding Site Partnerships to Optimize Study Execution

Jeffrey Zucker, MS, Vice President, Feasibility and Recruitment Optimization, Worldwide Clinical Trials

A barrier to successfully completing a clinical trial can be patient recruitment. While there may not be one solution to the issue, a key point has been lost over the last 20 years ― the relationship between site and sponsor. Although the merits of direct patient access cannot be denied, we need to re-engage our sites. Through these alliances, we will be able to increase efficiency with trial start-up, recruitment, and implementation. This discussion will suggest various methods to establish and maintain these key relationships while defining the impact on successfully conducted 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

Immo ZadezenskyImmo Zadezensky, PharmD, Ph.D., Clinical Pharmacologist, Professional Affairs and Stakeholder Engagement (PASE), Office of the Center Director, CDER, FDA

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

Jeffrey_RoseJeffrey Rosen, M.D., Medical Director, Clinical Research of South Florida; Associate Professor, University of Miami Miller School of Medicine



 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!)

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