eClinical Trials Solutions 

Track 7 focuses on innovative clinical technology solutions and best practice approaches to clinical research management. In addition to highlighting new tools for advancing clinical trials, we will explore the use of innovative approaches and technology to address challenges in clinical trial monitoring; and ensuring data quality, sharing, collection, standardization and integration.

Final Agenda

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7:00 am Workshop Registration and Morning Coffee

8:00 - 11:30 Morning Pre-Conference Workshops*

12:30 - 4:00 pm Recommended Afternoon Pre-Conference Workshops*

Advancing the Use of EHR/EMR for Clinical Research and Drug Development: Breaking Down Barriers & Building Up Bridges

*Separate Registration Required. Click here for detailed information.

2:00 - 7:00 pm Main Conference Registration

4:00 Event Chairperson's Opening Remarks

Cindy Crowninshield, RD, LDN, Conference Director, Cambridge Healthtech Institute


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5:00 – 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing




7:00 am Registration Open and Morning Coffee

8:00 Chairperson's Opening Remarks

Phillips Kuhl, Co-Founder and President, Cambridge Healthtech Institute


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9:00 Benjamin Franklin Award & Laureate Presentation

9:30 Best Practices Awards Program

9:45 Coffee Break in the Exhibit Hall with Poster Viewing

New Tools For Advancing Clinical Trials 

10:50 Chairperson's Remarks

Lisa La Luna, Senior Vice President, Corporate Development & Implementation, ePharmaSolutions

11:00 Cheaper, Faster, Better: Why You Should Be Moving to Online, Site-Independent Clinical Trials and Studies

Greg Biggers, Chief Instigator & CEO, Innovation, Genomera

The current and traditional methods for performing clinical research (studies and trials) are expensive, time consuming, and largely unchanged for the last 25 years. It is time to bring the research process into the Internet age, making staggering speed, cost efficiency, and participant engagement de rigueur. This talk will highlight the need for change, detail the promise of new cloud-based approaches, and tell the stories from a few case studies of successful Internet-mediated trials.

11:30 CAT: Collaborative Authoring Tool -- A New Way of Authoring and Reviewing Documents for Clinical Development

David Twomey, Associate Director, Software Architecture, Information Science for Translational Medicine, Novartis Institute for Biomedical Research

The clinical development process requires the collaborative authoring and reviewing of many documents. Managing the content, format and versioning of these documents is a challenge. CAT is a new web-enabled way to collaboratively author and review the documents associated with a clinical submission, removing the need for complicated document managing systems. CAT provides the authors with significant automation and re-use capabilities through the use of novel graphical user interfaces.

12:00 pm Seeing is Believing: Interactive Analysis for Clinical Data Exploration and Safety Review

Josh Patel, CFA, Team Leader, Clinical Informatics, PerkinElmer

TIBCO Spotfire interactive visualizations and predictive analytics enables proactive, responsive decision making, rather than retrospective tracking of results. Such proactive decision making can shorten the time between critical development gates and enable key milestones to be met sooner, while simultaneously managing safety risk. The platform allows for the development of solutions without significant strain on biostatistics and IT resources.

12:15 pm Sponsored Presentation (Opportunity Available)

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

Ensuring Data Quality while Improving Clinical Trial Monitoring 

1:50 Chairperson's Remarks

Speaker to be Announced

1:55 Case Study in Risk-Based Monitoring

Thomas Verish, Group Director, Data Operations Services, Bristol-Myers Squibb

A recent pilot has shown that the use of remote monitoring of clinical trials using trained staff and analytics can detect inconsistencies in data, which drives a site visit from the monitor. We will discuss the methodology followed, examples of tools that were used and what we learned from this experience.

2:25 Smarter Monitoring in the Age of Machine Learning

Michael Elashoff, CTO, Patient Profiles

Risk based-monitoring (RBM) done right can dramatically reduce the time and cost associated with clinical monitoring. RBM done wrong can result in a study with undetected errors and unfixed procedural problems. This talk will describe how to implement a RBM plan that uses newly developed methods for automatic error detection at the patient, site, and study level.

2:55 Smart Trials: Novel "Scientific Intelligence" Tools to Enable Advanced Clinical Trial Data Monitoring
Mark A. Collins, Ph.D, Director, Marketing, BioFortis, Inc.
Modern clinical trials are data rich but often knowledge poor. Leveraging clinical trial data in innovative ways can lead to improved trial outcomes, quality improvements and reductions in cost. Using a series of case studies we will demonstrate how novel data exploration tools that harmonize disparate clinical trial data streams and provide real-time monitoring can significantly impact trial outcomes. 

3:10 Sponsored Presentation (Opportunity Available)

3:25 Refreshment Break in the Exhibit Hall with Poster Viewing

Using Real-World Healthcare Data for Clinical Research 

4:00 Identification of Patient Populations Using Natural Language Processing on Real-World Healthcare Data

Scott DuVall, Associate Director, VA Informatics and Computing Infrastructure (VINCI), VA Salt Lake City Health Care System

Clinical research targets specific patient populations based on a distinct set of eligibility criteria, often based on current or history of medical conditions/diagnoses, treatment history and current health status. Some of these criteria can be queried using coded structured electronic healthcare data; however, in many cases the codes are not specific enough for the target medical condition. We will present specific examples of developing natural language processing to extract the relevant information directly from narrative clinical notes at high levels of accuracy to identify the target patient population. Examples will range from easy clinical concepts (e.g., a distinct condition that does not have a specific diagnosis code) to more complex clinical concepts requiring extraction of different pieces of information from different clinical notes and accounting for clinical notes temporally.

4:30 Secondary Uses of Healthcare Data: Improving Clinical Trials

Steven Labkoff, M.D., FACP, Head, Strategic Programs, R&D Information, AstraZeneca

5:00 Using Electronic Health Records to Improve the Feasibility and Generalizability of Clinical Trials

Chunhua Weng, Ph.D., Florence Irving Assistant Professor of Biomedical Informatics; Co-Director, Biomedical Informatics Core for CTSA, Columbia University

5:30 - 6:30 Best of Show Awards Reception in the Exhibit Hall


7:00 am Registration Open

7:00 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 Chairperson’s Opening Remarks

Kevin Davies, Ph.D., Vice President Business Development & Publisher C&EN, American Chemical Society; Founding Editor, Bio-IT World


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10:00 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced

Collaborative Approaches to Clinical Data 

10:30 Chairperson's Opening Remarks

Thomas Verish, Group Director, Data Operations Services, Bristol-Myers Squibb

10:35 PANEL DISCUSSION: Forming a Collaborative Approach to Develop a Data and Technology Blueprint

Muzafar Mirza, Director, Information Strategy and Analytics, Clinical Informatics and Innovation, Pfizer, Inc.

Georgina Wood, Global Head, Technology Innovations, Novartis

Francis Kendall, Global Head, Statistical Programming and Analysis, Roche

Matt Smith, Director, Bristol-Myers Squibb

William Turner, Global Head, Programming, Biometrics and Information Sciences, Global Medicines Development, AstraZeneca

Brooke Hinkson, Global Head, Clinical Information Governance, Clinical Sciences & Operations, Sanofi

This panel is a read-out of a collaboration between several pharma companies with the prime objective of devising solutions to the challenges that we face as an industry. This cross-pharma consortium focused discussions on technology, standards and data with a view to creating a common framework for how we process data, especially in the changing data landscape. Key focus areas included: Transition to CDSIC, Data Aggregation (including broad categories of data - Clinical Trial data, Payer databases, Registry data, Electronic Medical Records Genome data, Biomarker data and Legacy data), key technologies related to data warehousing/data reporting, validation of data analysis tools and open source approaches.

12:15 pm Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

1:15 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing

New Ways of Looking at Clinical Data 

1:55 Chairperson's Remarks

Thomas Verish, Group Director, Data Operations Services, Bristol-Myers Squibb

2:00 The 3R’s of Clinical Data in a Humanizing Drug Discovery World: Re-Use, Re-Analyze, and Reveal New Science

Catherine Marshall, Director, Information Strategy & Analytics, Clinical Informatics and Innovations, Pfizer

In the Pharmaceutical Industry, leveraging information stored in real world clinical study data, electronic health records, electronic medical records, and claims data to advance our understanding of human disease biology and identify therapeutic intervention points is essential in order to advance precision medicine science. Recognizing that large pharmaceutical companies have run thousands of clinical studies, there is a significant opportunity to capitalize on the science that can be obtained from the results of the studies alone. This session will explore three case studies demonstrating how clinical data is being re-used for exploratory research, some of the key challenges we face in making the most relevant data discoverable for scientific analytics, and how we might enable this type of research in a more efficient and automated manner than is possible today.

2:30 Roche’s Approach in Selecting a New Data Reporting Environment

Francis Kendall, Global Head, Statistical Programming and Analysis, Roche

Roche used a traditional approach to selecting a new data reporting environment; due to difficulties with the original project, a more novel approach in selection and assessment was adopted. This presentation explains Roche’s need to look for a new data reporting environment and provides an overview of the selection process and the current status of the project.

3:00 Co-Presentation: Establishing a PKPD Data Flow across a Multi-Vendor Framework

Stuart Pearce, Associate Director, Information Strategy and Analytics, Development Operations, Worldwide Research & Development, Pfizer, Inc.

Muzafar Mirza, Director, Information Strategy and Analytics, Clinical Informatics and Innovation, Pfizer, Inc.

This presentation demonstrates the importance of collaborating across vendors on a standard file format and process flow in the provision of PK and PD data for data modeling, clinical trial simulation and clinical reporting activities. Following the change in operating model in Pfizer it was essential that the timely deliverable of key data was delivered to a standard format whilst protecting the blind. This presentation will cover the challenges, solution and benefits of a standardized approach.

3:30 Ending the Clinical IT Lifecycle with Decommissioning of GCP Clinical Data

Jesper Ilm, Senior Consultant, Compliance & Validation, NNIT

Any clinical IT system will eventually end the journey in its lifecycle. When decommissioning the IT system a big question is what to do with data that are managed and controlled by the system? Companies do not know what to do to stay in compliance with GCP. This presentation covers an approach to define which clinical data can be deleted and which should be migrated when ending the lifecycle of GCP clinical data.

4:00 Conference Adjourns

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