Cambridge Healthtech Institute’s 11th Annual

Clinical Data Strategy and Analytics

Enabling Data Driven Clinical Trials

February 19-20, 2019

E-clinical technologies have changed the landscape of the clinical research industry and healthcare IT in general. Digitalization of healthcare data, mobile data capture technologies, and cloud storage of data are a few of the main technological advances that influence clinical data management and analytics. These technological advances have been coupled with novel data visualization solutions, and this powerful duo is helping to develop a new paradigm of data-driven clinical trials. Cambridge Healthtech Institute’s 11th Annual Clinical Data Strategy and Analytics conference is designed to bring together clinical research informatics experts to discuss the challenges and find solutions necessary to navigate and thrive in the rapidly changing environment.

Final Agenda

Stay on and attend Part 2 (Wed-Thurs): Artificial Intelligence in Clinical Research

Monday, February 18

9:00 am 7:15 pm Registration Open (Convention Level)

2:00 – 5:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:00 – 6:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:15 – 7:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee (Convention Level)

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Regency Q

10:35 Chairperson’s Remarks

Tine Lewi, PhD, MBA, Scientific Director, Janssen R&D, Clinical Innovation

10:40 Building a 21st Century Data Backbone

HallGreg_MaryMary Hall Gregg, PhD, Vice President, Business Technology, Research & Development, Pfizer

Clinical development organizations are changing how they collect, manage and analyze clinical data and new measures of clinical outcome are being adopted.  Data will be the fuel that powers machine learning and AI.  As a result we must re-imagine what is required to create a data powered organization that unlocks value and insights.  We will explore how information supply chains, elastic infrastructure, tools for data science, and automation enable a 21st century data backbone accelerating the delivery of new medicines to patients.

11:10 Digital Data Transfer (From EHR to EDC) and Inter-related Issues

Holen,_KyleKyle Holen, MD, Head, Development Design Center, AbbVie

With the increased use of electronic medical records world-wide, the clinical trial process of collecting, verifying, and analyzing relevant data to assess the impact of our interventions requires a re-visit into a process that is less manual labor intensive and allows for the ability to gain insights beyond the limitations of stated endpoints. Collaborations between AbbVie and academic medical centers as well as between AbbVie and data collection companies have initiated systems that will solve some of these challenges. The presentation at SCOPE will show some of the learnings gained from these collaborations and demonstrate a path where we can achieve a non-touch solution to clinical data transfer for all future trials.

11:40 CO-PRESENTATION: EHR2EDC, an Innovative European Public/Private Project to Optimize EDC Processes

Todorović_MarijaMarija Todorovic, Bridges Associate, Hospital Engagement Lead/Data Sciences, Janssen R&D, Clinical Innovation

Lewi_TineTine Lewi, PhD, Scientific Director, Janssen R&D, Clinical Innovation

EHR2EDC is a newly launched eIT funded consortium project which aims at facilitating the data extraction for applications used during trial execution, e.g. prefilling of CRF reports.  With the EHR2EDC project, we aim to avoid double data entry and source data verification, to collect subject data as soon as it is available, which will lead to continuous monitoring, but also to reduce data management costs, to convert data to a form suitable for analytics software and promote the reuse of the data. By using the real-world data, sourced from electronic health records, the EHR/RWD platform services will enable to have protocol feasibility improved, since the protocol testing will be done with RWD instead of estimates, patient recruitment will go faster, with established unified communication path between the sponsors and sites, and will also facilitate EHR data extraction that will be automatically uploaded in the applications used during trial execution (such as: eCRFs and of SAE reports). Presenters will introduce the initial set up of the studies, the process of identifying data elements eligible for automatic upload and the collaboration with the hospitals.

12:10 pm The Future of Automation in Managing Clinical Data and Operations

Young_Richard_EDCRichard Young, Vice President, Vault CDMS, Veeva Systems

Clinical Research of the future will be driven by personalization and data, increasing the demands on clinical data and operations teams. This presentation looks at how automation can transform our approach to trial design and execution, by modernizing data management to reflect the experiences we have in our everyday lives. Join this presentation for a look into how harmonized data exchange and process automation will revolutionize the work of our clinical data and operations teams.

12:40 Transition to Lunch

12:45 LUNCHEON PRESENTATION: Maximizing the Use of Data Hubs to Streamline Clinical Operations

Ramakrishnan_Sundaram_EDCSundaram Ramakrishnan, Venture Leader, Life Sciences, Cognizant

Data is your most valuable asset, but are your data management systems helping you improve decisions - or holding you back? In this session, we’ll discuss the most common data hub problems - and how to solve them. We’ll use a combination of best practices and case studies to help you discover how your data hub should improve your decision-making and streamline operations.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

Regency Q

2:05 Chairperson’s Remarks

Aman Thukral, Assistant Director, DSS, AbbVie

2:10 Patient Experience Captured through Digital Technology

SHOGREN_MICHELLEMichelle Shogren, Head, Innovation, Portfolio and Operations, Pharma Development, Bayer

In light of recent new FDA draft guidance around adding patient experience to the label, we need to think about what that means to Pharma and how we design clinical trials to be able to have the necessary data to support it. Join this session to learn more about this guidance and what could be done.

2:40 Create a Single Data Collection Hub to Promote Interoperability and Seamless Integration of Direct-to-Patient Activity

Baara_MuntherMunther Baara, MS, Head, New Clinical Paradigm, Pfizer

Innovative digital technologies are starting to disrupt the highly regulated and conservative biopharmaceutical industry.

  • Learn how a single data hub can be utilized to harmonize recruitment, eConsent, patient outcomes and other relevant systems that must be simplified for direct-to-patient trials
  • Capitalize on opportunities to remotely administer wearables and other trial activity
  • Develop understanding in the vendor community of the adaptations they need to make to their standards, systems and processes to utilize emerging hubs
  • Craft an implementation plan and develop cross industry buy-in and support

3:00 Converging Patient-Facing Technology Capabilities: The Pinnacle of Patient Centricity

Thukral_AmanAman Thukral, Assistant Director, DSS, AbbVie

Biopharmaceutical sponsors are experimenting multifold technologies to achieve patient centricity. This is increasing pressure on patients to use multiple sensors, apps and devices during clinical trials. The goal of this presentation to provide the framework for converging patient-facing technologies.

3:20 Enabling Patient-Centric Clinical Trials via Digital Health Technologies

Shah_JyotiJyoti Shah, Associate Director, Data Development, Merck

Digital technologies provide an opportunity to modernize the current site-centric clinical trial model by enriching the quality of data collected and enabling real-time decision making, thereby increasing probability of success. At Merck, we have conducted clinical pilots to determine this feasibility and our results demonstrated the feasibility and subject acceptance of these technologies for future clinical trial use.

3:40 Using Data and Technology to Design a Trial that Patients WANT to do!

Ben Quartley, PhD, Head, Feasibility, Recruitment, Engagement and m-Health, Covance

It’s a well-known fact that obtaining the right patients has long been a challenge for clinical trials. However, the real challenge comes from the ability to design a trial that patients actually choose to participate in. Covance has developed a methodology to use technology to realistically pinpoint accurate patient populations and design trials that patients actually want to do. Join us and learn to design trials effectively and efficiently.

Regency Q

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 (Plaza International Ballroom)

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open (Convention Level)

7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)

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

Regency Q

8:20 Chairperson’s Remarks

Karim Damji, Senior Vice President, Products and Marketing, Saama Technologies

8:25 Leveraging the Lean Start-Up Methodology to Adopt and Scale the Data and Clinical Analytics Strategy

Katta_NareenNareen Katta, Director, Operations Analytics, Data Sciences, Data and Statistical Sciences, AbbVie

The case study discusses the need for organizations to reimagine the operating model in order to unleash the full value of the clinical analytics, and the opportunity cost of implementing analytics on top of existing operating model.

8:55 Smart Dashboards: Our Journey to Building Interactive Process Performance Analytics Using Machine Learning

O'Brien_FayeFaye O’Brien, Director, Metrics and Performance, GMD, AstraZeneca

The Operational Excellence team at AstraZeneca piloted artificial intelligence tools to create a new interactive performance measurement dashboard for key clinical and regulatory processes. The machine learning tools ingest and process data from different access points across the business, make the data available for intuitive querying using natural language and create dashboards from results. During this session, we will walk you through this pilot including an overview of the technology and its benefits.

9:25 CO-PRESENTATION: Using Metrics and Visualizations to Change the Way We Work

Ott_KevinKevin Ott, Clinical Operations Data Analyst, Clinical Affairs, Cardiovascular Systems, Inc.

Christopherson_KyleKyle Christopherson, Director of Clinical Affairs, Cardiovascular Systems, Inc.

In less than 18 months, the Clinical Affairs Team at CSI swiftly evolved into a data-driven organization with over 20 tools and visualizations created to support the execution of their Clinical portfolio. Join the presenters as they walk you through their journey of how this small team defined critical needs, developed compelling metrics, introduced new tools, and integrated metrics into the organizational workflow for action and decision making. Technical solutions, development approaches and challenges will be outlined along with lessons learned during the course of process integration and department adoption. In the spirit of SCOPE’s shared learning environment, key interactive visualizations will be showcased to highlight their implementation of clinical metrics, directed actions and associated results.

9:55 Presentation to be Announced

10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Regency Q

11:20 Chairperson’s Remarks

Hugh Levaux, PhD, Founder and CEO, Protocol First

11:25 Where Is the Internet of Medical Things Taking Clinical Research?

LaPorte_JacobJake LaPorte, PhD, Vice President, Global Head, Digital Development, Novartis Pharmaceuticals Corporation

The Internet of Medical Things (IoMT)—the network of physical healthcare devices that are able to generate and exchange data remotely—is one of the fundamental driving forces of the digital transformation in healthcare. IoMT will have significant implications for how clinical research is conducted including the development of digital endpoints and evidence to measure the effects of medicines in new ways. Where is clinical research heading and how can we harness these new technologies to develop better, more effective medicines faster?

11:55 The Digital Health Ecosystem: The “New” People, Technologies and Processes Needed to Scale Up the Use of Digital Health in Pharmaceutical Development

Rowe_AnthonyAnthony Rowe, PhD, Director, Business Technology Leader, R&D IT, Janssen R&D

It is becoming increasingly valuable to leverage digital technology in a clinical trial environment to differentiate therapy, provide rapid insights and provide patient centric solutions. This talk will aim to discuss how to move beyond ongoing digital health “pilot-itis” and describe the ecosystem of functions and capabilities that are needed to scale the use of digital technologies in clinical operations.

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Portfolio Risk Mitigation

Gulwadi_AmitAmit Gulwadi, Senior Vice President, Clinical Innovations, Saama Technologies

1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

2:10 Close of Conference

Stay on and attend Part 2 (Wed-Thurs): Artificial Intelligence in Clinical Research


SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

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

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