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
9:45 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 Loftiss, Senior Director, Oncology Clinical Ops Head, AZ/MedImmune
Jane 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 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 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).
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12:05 pm Putting Patient and Site Engagement at the Center of Your Clinical Trial
Jonathan 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.
12:35 Luncheon Presentation: EHR-EDC Integration an eSource Imperative
Keith Howells, Senior Vice President, Product Development, OmniComm Systems, Inc.
1:20 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 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 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
Panelists:
Elisa Cascade, MBA, President, DrugDev Data Solutions,
Kelly Kirsch, MPH, Consultant-Shared Investigator Platform, Clinical Development Information and Optimization, Eli Lilly and Company
Munther 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.
3:20 Simplifying the Clinical Trial Regulatory Submissions Process
Barbara 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
7:45 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 Thukral, Senior Manager, DSS, Abbvie
8:30 Visual Analytics: Sailing Big Data in Clinical Research
Charlie 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 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 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.
10:10 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 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 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.
12:10 pm Bridging Luncheon Presentation: Pairing Analytics: Solutions Designed to Better Navigate Clinical Trial Data
Thomas J. Gfroerer, Executive Director, Data Analytics, PPD
Tammy 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.
12:50 Coffee and Dessert in the Exhibit Hall
1:30 Close of Conference