Cambridge Healthtech Institute’s 9th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management

Improving Outcomes through Strategy, Relationships, Data and Execution

February 19-20, 2019

Data-driven global site selection, an optimized protocol development and feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to trial planning and execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize data and analytics to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. CHI’s 9th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” will cover the topics one should consider when planning and implementing a trial.

Final Agenda

Stay on and attend Part 2 (Wed-Thurs): Improving Site-Study Activation and Performance

Monday, February 18

9:00 am 7:15 pm Registration Open

2:005:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:006:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award

6:157:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall


10:35 Chairperson’s Remarks

Laura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc., and TransCelerate Program Lead

10:40 CO-PRESENTATION: Evidence-Based Site Selection Profiles

Rowe_JonathanJonathan Rowe, PhD, Executive Director, Head of Clinical Development, Quality Performance and Risk Management, Pfizer

Serra-Ortiz_OriolOriol Serra Ortiz, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

Historical site GCP quality performance data can be a useful decision point in combination with other site metrics for future site identification. A model incorporating a number of variables that reflect site performance, start up and site’s GCP status will be described along with real examples of its utility in site identification and performance predictions.

11:10 Feasibility for Early Stage Studies in Oncology

Fites_MichaelMichael Fites, Senior Feasibility Strategist, Global Clinical Trial Services, Bayer

Early stage trials (First in Human, Basket Trials) present a unique design with adaptive planning. As such, feasibility in early stage trials requires a tailored and flexible approach in order to identify the optimal sites for study conduct. This presentation will share details and key learnings.

11:40 INTERACTIVE PANEL: Study Planning, Site Identification and Feasibility: Strategies for Success in Centralised and De-Centralised Organizations

Cascade_ElisaModerator: Elisa Cascade, President, Data Solutions, DrugDev

Gomez_LorenaLorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan

Serra-Ortiz_OriolOriol Serra Ortiz, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

Galuchie_LauraLaura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc., and TransCelerate Program Lead

This panel discussion will take a look at study planning, site identification and feasibility in 3 different companies, with a focus on strategies for success in companies that have largely centralised functions governing these processes vs. those that have a more de-centralised model with local responsibility for such tasks. In addition, the session will provide input on tactics (successful and unsuccessful) for driving standardization and evidence-driven activities. Topics to be discussed:

  • Understand the different organizational structures that inform approaches to study planning, site identification and feasibility
  • Identify challenges and opportunities that arise from both a centralized and a de-centralized approach
  • Based on these insights, discuss best practices for strategies for study planning, site identification and feasibility based on organizational structure

12:10 pm Optimize Your Recruitment Efforts for Highly Competitive Patient Populations

Branon_LoniLoni Branon, Senior Director, Sitetrove Citeline, Informa – Pharma Intelligence

Johnson-OtisOtis Johnson, PhD, Vice President, Feasibility and Informatics, ICON Clinical Research

Are you making the best site selection decisions as you design and plan your next clinical trial? Come join us to review patient-centric strategies that include creating new lines of communication with physicians and clinical investigators to increase study awareness and verification of access to the right patients. Creating these powerful connections enables increased patient and physician engagement, resulting in faster, more targeted patient identification and enrollment. Learn some newer approaches being used to analyze data to find the desired sites and patients.

12:40 Transition to Lunch

Synexus 12:45 LUNCHEON PRESENTATION to be Announced


1:25 Coffee and Dessert Break in the Exhibit Hall


2:05 Chairperson’s Remarks

Lorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan

2:10 CO-PRESENTATION: Applying a Data-Centric Approach to Feasibility and Site Selection

Smyth_SandraSandra Smyth, Director, Central Feasibility and Recruitment Group, AstraZeneca

Teufel_MicheleMichele Teufel, Patient Engagement Lead, Clinical Operations, AstraZeneca

This presentation will report AstraZeneca’s recent transformation initiative focusing on patients, sites, and data-centric approaches to improve feasibility and site selection in late-stage studies. We will talk about the data sources involved, and other tools and strategies implemented for site selection and continuous predictive forecasting. We will share learnings from our experiences in terms of using historical and RWD data balanced with local insights to inform site selection decisions in a global organization.

2:40 Using RWE and Data Analytics for Enhanced Feasibility and Site Selection Strategies

Everill-Flinders_MichelleMichelle Everill, Senior Director, Head of Global Feasibility, Janssen

As more varied data sources are becoming available across multiple industries, the potential to merge, overlay, and analyze data is proving to increase the ability to be predictive in achieving better operational and recruitment outcomes. Case studies utilizing RWE and varied data sources will be shared to highlight how insights were derived and applied to increase success and risk mitigation strategies.

3:10 INTERACTIVE PANEL: Quantifying Patient Burden to Improve Clinical Trial Planning and Execution

Carozza_DianeModerator: Diane Carozza, Managing Senior Engagement Consultant, Medidata Solutions

Schwager_SteveSteve Schwager, Professor Emeritus, Cornell University

Williams_AshleyAshley Williams, Associate Director, Global Clinical Operations, Biogen

The burden of a trial and its procedures on a patient has the potential to substantially impact patient retention in a study. Sponsors have traditionally relied on subjective measures to understand this patient burden. New tools are available that provide an objective framework for quantifying and visualizing the burden on the patient from a procedure, a visit, and the overall protocol. Learn from our panel how clinical operations professionals are taking a data-driven approach to making patient-centric modifications to trial designs. Topics to be discussed:

  • What is the value of incorporating patient burden into study design and strategies to improve patient retention?
  • What are data-driven tools that can provide an objective framework for patient burden and its use by clinicians and patient experience teams to bolster patient retention?
  • How can clinical operations and protocol designers make the important shift from subjective, often ad hoc assessment of patient burden to an objective, data-driven approach to improve patient-centricity in clinical trials?

3:40 Using Data Science and Technology to Design and Deliver Better Clinical Trials

Kindman_Allen_SSGAllen Kindman, MD, Vice President, Clinical Planning and Analytics, IQVIA

Access to data and innovative technology developments are enabling better protocol design and more efficient execution of clinical trials. In this presentation we will discuss how you can: - Assess and optimize your protocol using real-world data to avoid protocol amendments - Create precise and predictable study strategies - Provide seamless operational deployment, at scale, to deliver enrollment and high quality.


4:10 Find Your Table and Meet Your Moderator

4:15 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent

Delente_EricEric Delente, President, Patient Consent, DrugDev, An IQVIA Company

This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.

8:15 Session Break


8:20 Chairperson’s Remarks

Chairperson to be Announced

8:25 CO-PRESENTATION: Unknown Unknowns: Leveraging Technology to Identify Blind Spots in Country and Site Feasibility Data

Tedman_ShawnShawn Tedman, MBA, Head, Trial Optimization Offerings, Clinical Trial Optimization Solutions, IQVIA

Serra-Ortiz_OriolOriol Serra Ortiz, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

Increasingly sophisticated data sources are becoming more readily available to site and country selection teams for use in feasibility assessments. As teams look to add to their tool kits, there are necessary trade-offs that must be made due to limited resources – and some very expensive data options. Where do teams get the best return on their data investment? It’s valuable for these tradeoffs to be informed by an understanding of the feasibility data landscape and the value added by each category of data.

8:55 Rescue Sites: An Analysis Framework and Associated Cross-Company Findings

Gomez_LorenaLorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan

The burden of adding rescue sites during a study to pharma companies is considerable in terms of time and cost, and yet understanding the landscape of rescue sites is limited. This session will present a framework for benchmarking use of rescue sites and associated findings from an analysis of shared CTMS from 13 different pharma companies. Specifically, we leveraged this data to investigate the distribution of sites activated and patients enrolled overall, and at the country and therapy level.

9:25 Foolproof Feasibility: Matching Standard of Care with Clinical Feedback and Site Intelligence

Chadha_Manek_DivyaDivya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network

In the UK the National Institute for Health Research (NIHR) has developed a unique national strategy for delivering reliable feasibility reports using a three-pronged approach to be presented in detail. This foolproof approach to achieving accurate feasibility information is underpinning research delivery success in the UK and has contributed to record-breaking ‘time and target’ performance results (74%) for commercial contract research (74% figure is based on 466 commercial studies that closed in financial year 2017/18, 346 of which recruited 100% of their target within planned timescales).

HighPointClinicalTrials 9:55 Presentation to be Announced


10:25 Coffee Break in the Exhibit Hall


11:20 Chairperson’s Remarks

Michael Fites, Senior Feasibility Strategist, Global Clinical Trial Services, Bayer

11:25 Partnering with Qualified Investigators and Study Teams for Improved Site Performance, Efficiency, and Execution of Clinical Trials

Goldstein_KathyKathy Goldstein, PharmD, Senior Director, Head, Quality Management Lead, Regeneron Pharmaceuticals

Current approaches to investigator qualification make it difficult for sponsors and CROs to identify study teams that are well-prepared for the quality conduct of clinical trials. This session will report recommendations from the Clinical Trials Transformation Initiative (CTTI) that are intended to disrupt current approaches to investigator qualification, resulting in 1) more streamlined and efficient learning, and 2) improved execution of study protocols. For example, reduced recruitment timelines, improved patient retention, and less time spent resolving discrepancies.

11:55 INTERACTIVE PANEL: The Missing Ingredient that Most Impacts Successful Site Performance

Harper_BethModerator: Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

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

Schantz_DougDoug Schantz, Executive Director, Clinical Operations, AstraZeneca


Byrne_JenniferJennifer Byrne, Founder and President, Greater Gift, former CEO, PMG Site Network

What matters most in clinical research is the people doing the work; however, staff qualifications are often not considered when it comes to site selection. There is a growing body of evidence to support the impact that more highly-qualified staff have on performance and the operational efficiencies that can be gained when these sites are used. Topics to be discussed:

  • Current site selection processes and gaps in the data collected
  • The value of site staff qualification analysis and standardization of competencies
  • Industry issues associated with variance in site staffing training, development and assessment

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Brindle_Bob_SSG&SSUBob Brindle, Venture Leader, Life Sciences, Cognizant

How much effort do you waste during clinical trial protocol creation? How do you know? How do you fix it? In this increasingly digital world, it’s frustrating to be constrained by traditional word processing tools, but making the shift to a digital process can be daunting. Join this session to discover the practical steps that will set you up to transform your process - and get a peek at what a digital protocol will enable.

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Close of Conference

Stay on and attend Part 2 (Wed-Thurs): Improving Site-Study Activation and Performance


“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions

Signature Sponsors



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