Clinical IT Strategy and Governance

 E-clinical technology is getting more sophisticated every year; and every year it faces new challenges induced by the changing 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 research informatics. Cambridge Healthtech Institute’s 8th Annual “Clinical IT Strategy and Governance” conference is designed to bring together clinical research informatics experts to discuss the challenges and find solutions necessary to navigate and thrive in this rapidly changing environment.


Clinical IT Strategy and Governance

Innovative Data Strategies to Optimize Clinical Trials

Monday, February 22

7:00 – 9:00 pm Welcome and Networking Happy Hour on the Riverwalk hosted by CHI, DrugDev and Praxis

Tuesday, February 23

7:15 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes - View Details

Biomedical Systems9:45 Grand Opening Coffee Break in the Exhibit Hall



10:45 Chairperson’s Remarks

Jaydev Thakkar, IS Director, R&D Informatics, Amgen

10:50 Building a Trial Design Library to Optimize Protocol Development and Clinical Program Strategic and Operational Positioning In Immune-Oncology TA

Joint Presentation:
Jill_LoftissJill Loftiss, Senior Director, Oncology Clinical Ops Head, AZ/MedImmune

Jane_FangJane Fang, M.D., Director, R&D IS Lead, Clinical Business Management & Analytics, AstraZeneca/MedImmune

As industry competition in the Immuno-oncology field becomes fierce, trial protocols become much more complex to validate potential new medicines against right patient population. This presentation is about accelerating better protocol development by building a Trial Design Library to extract, compare and analyze the key study design information. Trial Design Library provides a reference of key inclusion and exclusion criteria by disease areas and indications for the study teams. It also provides deep analysis of patient population requirements to optimize trial design and enable strategic planning and execution of clinical programs that could be potentially competing with or complementing each other.

11:15 Data Visualization Enabling Clinical Scientists in Decision Making

Francis_KendallFrancis Kendall, Global Head, Statistical Programming and Analysis, GLIDE Future Investigation Team Lead, Genentech

This talk will describe how Roche Biometrics is helping promote the use of visiualisation tools to help gain greater insight and quicker decision making on clinical trial data. I will explain how and when we propose each tool should be used and give a few examples on how these approaches are helping the business. Tools that Roche currently use in this area are Spotfire, Tableau, SAS, & R Shiny.

11:40 Streamlining Clinical Trials by Leveraging New Technologies

Jaydev_ThakkarJaydev Thakkar, IS Director, R&D Informatics, Amgen

Today’s competitive R&D landscape demands effective use of technology to reduce cost and cycle time from Clinical Development phase. This presentation will take you on a journey to implement an integrated Clinical Development platform with a suite of new, integrated technologies that streamline the execution of clinical trials from study design & feasibility through study conduct & analysis. The discussion will also include the exploration of new, innovative digital health solutions for the next generation of clinical trials and patient engagement (e.g. mHealth Apps, Wearables & Sensors).

ClinicalInk12:05 pm Putting Patient and Site Engagement at the Center of Your Clinical Trial

Jonathan AndrusJonathan Andrus, BA, MS, CQA, CCDM, Chief Data Officer, Clinical Ink

This presentation will focus on exploring recommendations and ideas around ways to use technology to ensure that site staff are engaged in the collection of clinical trial data in a manner that reduces workload, redundancies and the need for transcription of data. We will explore how to enhance the patient experience in clinical trials and methods in which sites can engage patients using technology. These include medication reminders, updates on the study, site staff interactions with patients via messaging, informational videos and interactive media all of which help to increase patient retention and satisfaction.

OmniComm12:35 Luncheon Presentation: EHR-EDC Integration an eSource Imperative

Keith HowellsKeith Howells, Senior Vice President, Product Development, OmniComm Systems, Inc.

Biomedical Systems1:20 Coffee and Dessert in the Exhibit Hall



2:00 Chairperson’s Remarks

2:05 How the Advancement of Technology Will Impact the Business Model of Clinical Trial Execution

Munther_BaaraMunther Baara, Senior Director, Development Business Technology, Pfizer

There is no day passes by where we don’t hear about new technology and initiatives helping business bridge the gap and evolve the organization though digital transformation. Will the new digital advancement, Internet Of Things (IoT), mobile, social media, advanced analytics/big data and cloud disrupt savvy companies and transform the way they do business? I will discuss the new paradigm shift, which requires us to move beyond our current thinking and assumptions to find ways to pave the way to transform the way we execute Clinical Trials.

2:30 Adoption of Innovative E-Clinical Technology: Case Studies

Kelly_KirschKelly Kirsch, MPH, Consultant-Shared Investigator Platform, Clinical Development Information and Optimization, Eli Lilly and Company

Adopting and implementing new technologies in Clinical Research can pose challenges given the various internal and external stakeholders. In this session, tactics will be shared to describe an Organizational Change Management approach to implementing two technology solutions in a clinical research organization at Eli Lilly and Company. The Presenter will describe lessons learned from implementing the Shared Investigator Platform and an e-Trial Master file.

2:55 Panel Discussion: Standardizing Clinical Trial Operations Data Across the Industry: A Look Inside the TransCelerate Investigator Registry Data Model

Elisa_CascadeElisa Cascade, MBA, President, DrugDev Data Solutions,

Kelly_KirschKelly Kirsch, MPH, Consultant-Shared Investigator Platform, Clinical Development Information and Optimization, Eli Lilly and Company

Munther_BaaraMunther Baara, Senior Director, Data Management & Reporting, Pfizer

This session will take a look into the data model that sits behind TransCelerate’s Investigator Registry (IR), a service which enhances the Shared Investigator Platform (SIP) and accelerates identification and recruitment of qualified investigators through data standardization and integration. At the heart of the data model is the need to identify a unique person through a front-end identity provider (Exostar) and the ability to link this person with their historical information from other data sources via the DrugDev Golden Number for persons and facilities.

Datatrak3:20 Simplifying the Clinical Trial Regulatory Submissions Process

Barbara NorrisBarbara Norris, Manager, Sales Operations, DATATRAK

The regulatory submission process can be time-consuming, stressful and tedious. Technology can deliver efficiencies through powerful reporting, elimination of redundant tasks and mitigation of risk due to human error. See how common complexities are eliminated with a modern cloud-based CTMS solution, providing more efficiency for your clinical research team.


3:55 Find Your Table and Meet Your Moderator

4:00 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. 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.

Complete list of Breakout Discussion Groups

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 24

7:15 am Registration

QUINTILES7:45 Breakfast Presentation: Operational Excellence in Real-World Research: Observational Studies & Registries

Radha Puri, Associate Director, Americas, Real-World Evidence Strategy Unit, Real-World Late Phase Research, Quintiles

Obtaining and maintaining operational excellence in real-world research requires connecting insights for better outcomes. Understand the challenges to mitigating risks while maximizing data quality and hear how to achieve and maintain quality standards in observational studies and registries while minimizing site burdens.


8:25 Chairperson’s Remarks

Aman_ThukralAman Thukral, Senior Manager, DSS, Abbvie

8:30 Visual Analytics: Sailing Big Data in Clinical Research

Charlie_RomanoCharlie Romano, Senior Director, Clinical Trial Management, Clearside Biomedical

Whether designing a hot new study or standing in the remnants of a terminated project, determining whether a program is excelling or stalling is an old science with some new tools. With millions of dollars, new indications and patients’ lives depending on our innovation, what do you watch in the spyglass to see where your program is going? In this session, we will examine some useful measures for study startup, execution and conclusion.

8:55 eClinical Optimization to Build Operational Excellence through Smart Integration and Performance Driven Dashboard

Ron_BourqueRon Bourque, Associate Director, RDI, AZ/MedImmune

eClinical strategy and implementation is a key component to modernize and accelerate clinical trial conduct and delivery. This talk is to present a use case of designing and implementing an eClinical optimization strategy and roadmap to enable meaningful use of trial information to answer important business questions. The use case will share the key elements to achieve a successful implementation of eClinical strategy.

9:20 A Robust Implementation of Risk-Based Monitoring

Dimitris_AgrafiotisDimitris K. Agrafiotis, Ph.D., Vice President and Chief Data Officer, Covance

We present a new risk-based monitoring platform that uses advanced data integration, analytic, and visualization capabilities to provide unprecedented access to all clinical trial data, enable comprehensive assessment and mitigation of risk at the study, site, and patient level, and allow central monitors to direct CRAs to the right locations with the right frequency to assure patient safety, data quality and protocol compliance with greater insight, speed, and efficiency.

9:45 Leveraging Clinical Architecture to Optimize Your Organization’s Business Processes and Technology Effectiveness 

Chris McSpiritt, Associate Director, Life Sciences R&D, Paragon Solutions, Inc.

Pharma organizations face challenges when selecting and implementing technology; including the emergence of disruptive technologies, complex outsourcing models and industry initiatives that impact the way research is conducted on a global scale. More often companies are implementing new technology without considering the downstream impact on compliance, operational efficiency or long term return on investment. Learn how clinical architecture can help organizations improve the effectiveness of their IT/R&D planning cycles and overall solution life cycle management.

Alpha Clinical Systems10:10 Coffee Break in the Exhibit Hall



11:10 Chairperson’s Remarks
Aman Thukral, Senior Manager, DSS, Abbvie 

11:15 Metadata Repository and Clinical Data Repository - Taking Clinical Development to Next Generation

Joint Presentation: Malcolm Garden, Principal Architect, IS Lead for CDR Project, Amgen

Dylan_RosserDylan Rosser, Director, Global Development Organization, Business Process Lead, CDR project, Amgen


11:40 Next Generation eClinical Data Platform for Clinical Data Aggregation to Generate Meaningful Insights

Nareen_KattaNareen Katta, Associate Director, Data and Statistical Sciences, Abbvie

Clinical data repositories gather data from multiple sources like EDC, CTMS, IRT, Drug Supply system and in order to standardize data in unified format to generate meaningful insights is a tedious task. This case study discusses the challenges and implementation experience of AbbVie in developing next generation data warehouse.

 PPD12:10 pm Bridging Luncheon Presentation: Pairing Analytics: Solutions Designed to Better Navigate Clinical Trial Data

Thomas J. GfroererThomas J. Gfroerer, Executive Director, Data Analytics, PPD

Tammy JacksonTammy Jackson, Director, Preclarus Development, Biostatistics, PPD

Sponsor companies and CROS have distinct data needs throughout the conduct of a clinical trial. Analytic solutions and visualization tools can help with efficient exploration of the data. This talk will show how coupling uniquely designed analytic solutions can help deliver new approaches to risk surveillance, study management and monitoring safety trends for both sponsors and CROs.

Alpha Clinical Systems12:50 Coffee and Dessert in the Exhibit Hall

1:30 Close of Conference

Suggested Event Package*

2:00 – 5:30 pm SC2: Visual Analytics - An Immersive Workshop for Clinical Researchers in Pharma & Device Trials - Detailed Agenda

February 23-24: Clinical IT Strategy and Governance Conference

February 24-25: Clinical Data Technology and Integration Conference

* Separate registration required