Track 7 explores views, insights, and informatics challenges related to innovative clinical research management. Themes covered include innovations in development planning and protocol design; new approaches to sponsor-CRO and sponsor-site relationships; novel patient recruitment and retention strategies and practices; clinical ops and project management; clinical trial technologies and data integration; and utilization of EHRs to optimize trial design and management.

Final Agenda

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TUESDAY, APRIL 9

7:00 am Workshop Registration and Morning Coffee

8:00 Pre-Conference Workshops*

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

Cloud Computing in Hospital Data Management and Integration 

*Separate Registration Required

2:00 - 7:00 pm Main Conference Registration

4:00 Event Chairperson’s Opening Remarks

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

4:05 Keynote Introduction

Kevin Brode, Senior Director, Health & Life Sciences, Americas Hitachi Data Systems

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

Drop off a business card at the CHI Sales booth for a chance to win 1 of 2 iPads® or 1 of 2 Kindle Fires®!*

*Apple® is not a sponsor or participant in this program

WEDNESDAY, APRIL 10

7:00 am Registration and Morning Coffee

8:00 Chairperson’s Opening Remarks

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

8:05 Keynote Introduction

Sanjay Joshi, CTO, Life Sciences, EMC Isilon

8:55 Benjamin Franklin Award & Laureate Presentation

9:15 Best Practices Award Program

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

Leveraging Data and Technology for Protocol Feasibility and Patient Recruitment 

10:50 Chairperson’s Remarks

Jennifer Wulff, Director, Clinical Innovation, Pfizer World Wide Research & Development

11:00 Impact of the Electronic Health Record on Research

Doug Berman, Deputy Director, Academic Research Systems, University of California San Francisco

Medical centers nationwide have been adopting Electronic Health Record systems rapidly. These systems have the potential to make large and meaningful contributions to clinical trials and other research activities. This talk will review the experience, challenges and achievements of an academic medical center.

11:30 Using Real World Data to Facilitate Protocol Feasibility Assessment and Patient Recruitment

Sergio Eslava, M.D., Principal Biomedical Informatics Scientist, Biomedical Informatics, Real World Evidence, AstraZeneca

Clinical protocol design and patient recruitment for clinical trials bring many challenges for the sponsor. This presentation focuses on how real world data sources such as electronic health records, personal health records and patient centric communities can support clinical research in facilitating clinical protocol design and feasibility assessment as well as patient recruitment for clinical trials. The use of these data sources in combination with a variety of services offered by some data vendors can result in a significant cost reduction for the sponsor and increased efficiency in designing and executing clinical studies.

12:00 pm Real-World Data: Mining Electronic Health Records for Clinical Trial Recruitment and Personalized Medicine

Abigail Bracha, Ph.D., Vice President, Clinical Research & Informatics, CliniWorks, Inc.

CliniWorks will speak about mining real-world patient data including unstructured, free-text physician notes and clinical summaries, that found in structured EMR, and semi-structured to determine patient eligibility for clinical trial inclusion, ultimately accelerating eligible subject recruitment. CliniWorks is working across the product lifecycle from clinical trial recruitment though post-approval outcomes analyses and pharmacovigilance, and will speak to the impact of these tools from mining to outcomes and drug safety and performance. The use of disease biomarkers and genetic profiling, which are becoming an increasingly critical component of drug development and personalized medicine, will also be addressed.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

Optimizing Trial Management with Technology 

1:40 Chairperson’s Remarks

Suresh Kannan, Vice President, Product Development, Clinical Trial Optimization Solutions, IMS Health

1:45 Considerations for Planning and Assigning Trial Optimization Resources

Daniel Chain, Informatics Analyst, Global Trial Optimization, Merck

Successfully developing a drug and bringing it to market is expensive. Pharmaceutical development resources must therefore be optimally allocated to avoid adding to the expense. This session will cover techniques that can be used to predict trial optimization resource demands.

2:15 Rethinking Clinical Research Challenges in a Data-Rich World

Jennifer Wulff, Director, Clinical Innovation, Pfizer World Wide Research & Development

All too familiar are the many challenges faced across the drug development process, including target validation, patient recruitment, site selection and data reporting. How can, and do we think differently about tackling those challenges using the growing availability of real world data? How can we innovate parts of the clinical research process using a combination of new technology and electronic data? We will explore these topics and discuss ways to think differently about the use of data across all areas of drug development.

2:45 Electronic Source Documentation in Clinical Trials - Integration with EDC/CTMS: A Case Study

Thomas E. Serena, M.D., Founder, Serena Group

Conducting studies using an iPad/tablet based eSource Document System makes it efficient to capture reliable, quality, traceable and validated source data directly on eSource documents, improves the productivity of investigative sites and making the Source Documents/CRF’s availability for monitoring immediately; reducing monitoring time and costs and expediting the entire process of Clinical Trials. Through a case study example, attendees will gain good understanding of eSource Documents. 

3:15 Refreshment Break in the Exhibit Hall with Poster Viewing

3:45 A Common Tool for Investigator Site eSource-Readiness Assessment across Companies and across US & EU

Catherine Celingant, Senior Director, Medical Business Operations, Medical Strategy & Operations, Millennium: The Takeda Oncology Company

The eClinical Forum developed an assessment tool that sponsors, EHR system vendors, CROs, and clinical investigators can successfully use to evaluate EHR systems that will be the source of pertinent clinical research data. Sites will become more compliant over a shorter period of time due to proposed work-arounds, assessment updating, and encouragement from SW vendors and sponsors. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites. The assessment tool is currently being piloted at many investigator sites in both the US and Europe using several different research sponsors and EHR vendors.

4:15 Co-Presentation: POC Today/Practical Application Tomorrow: An Inside Look at How Several Companies Are Exploring Identity Management in the eClinical Trial Space

Mollie Shields-Uehling, MA, President and CEO, SAFE-BioPharma Association

Kerri Weingard, COO, Verified Clinical Trials

The proposed session will present the way several global companies are utilizing universal identity management protocols (a single cyber-identity recognized by all sponsors) to maximize use of mobile devices in clinical trials. The information will be based on the results of numerous proofs of concept currently underway, including use of tablets to collect patient data in hospital black-out zones, signing ePrescriptions, managing access to clinical portals, etc.

4:45 Co-Presentation: Best Practices for Risk-Based Approaches to the Monitoring of Clinical Trials

Paula McHale, Senior Director, Product Management, DataLabs EDC

Deborah Lucas, Principal ePRO Analyst, Biogen Idec

With the adoption of risk-based monitoring those engaged in clinical trial conduct must refocus energies on aspects of the clinical trial that matter most, such as protocol compliance, subject safety, data timeliness, and data integrity. Through the use of more up-to-date methodologies and technologies, companies can effectively address these concerns while saving both time and money. In light of the current buzz around risk based approaches to monitoring of clinical trials, the eClinical Forum created a task force to prepare a Best Practices Guideline to Monitoring of Clinical Trials. A more holistic approach to risk identification and mitigation is discussed and promoted.

5:15 Best of Show Awards Reception in the Exhibit Hall

6:15 Exhibit Hall Closes

Thursday, April 11

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

Data Collection and Integration 

8:45 Chairperson’s Opening Remarks

Laurie Milligan, Director, IT Strategy, R&D IT, Medicines Development Capabilities, GlaxoSmithKline

8:50 Clinical Trial Data Quality in the Cloud

Julia Zhang, Ph.D., Director, Strategy, Standard and Architect, Genzyme

This presentation will discuss how to improve data quality by implementing standards, efficiently using metadata repository, and applying the cloud technology to enhance the process efficiency and effectiveness. The discussion will range from how to develop data governance, design data by keeping the enterprise vision in mind, set strategy for data collection, processing and reporting through implemented standards and cloud technology.

9:20 Empowering the Cardiovascular Translational Exploration through a Unified Pre-Clinical and Clinical Data Environment

Xia Wang, Ph.D., Principal Biomedical Informatics Scientist, Global Medicines Development, R&D, AstraZeneca LPs

The presentation provides a case study to develop a clinical/pre-clinical cardiovascular (CV) data exploration environment with aiming to answer some fundamental translational questions. This environment enables end users to search, query, visualize, analyze and export CV data rapidly, across in vitro assays, in vivo animal studies, and clinical trials. The successful learning from this case study will lay the foundations to integrate and analyze other domains of clinical/pre-clinical data.

9:50 Using Collaborative Analytics to Transform Global Site Allocation

Fabio Thiers, M.D., Ph.D., CEO, ViS Research Institute

Global site allocation is cost-inefficient and needs to be revamped. The problem is that analytics about sites and locations where they operate is disaggregated, outdated, highly complex or simply non-existent. Issues with the current evaluation systems lead to heavy reliance on one-off requests for information (feasibility questionnaires), which rarely lead to long standing relationships between sites/investigators and sponsors. The solution is an open access analytics platform where multidimensional disease-specific feasibility analytics can be securely shared, kept up-to-date, and be easily understood. The benefits are faster/better site selection at substantially lower costs.

10:20 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced

10:45 Plenary Keynote Panel Chairperson’s Remarks

Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World

10:50 Plenary Keynote Panel Introduction

Yury Rozenman, Head of BT for Life Sciences, BT Global Services

Niven R. Narain, President & CTO, Berg Pharma

12:15 Luncheon in the Exhibit Hall with Poster Viewing

Collaborations in Clinical Trials 

1:55 Chairperson’s Remarks

Mollie Shields-Uehling, MA, President and CEO, SAFE-BioPharma Association

2:00 Collaboration within the Pharma Industry to Improve the Quality of Clinical Studies and Bring New Medicines to Patients Faster

Laurie Milligan, Director, IT Strategy, R&D IT, Medicines Development Capabilities, GlaxoSmithKline

The Pharma industry continues to simplify aspects of clinical development by focusing on people, process, standards, and technology. This is a fundamental transformation in the ways we work and the ways we use technology. To achieve this, we should consider our internal organizations as well as collaboration across the industry.

2:30 The Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Platform as a Unique Industry, Academic, and Foundation Collaboration to Generate a Novel Research Resource

Alexander Sherman, Director, Systems, Neurological Clinical Research Institute, Massachusetts General Hospital

A Pooled Resource Open-access ALS Clinical Trials (PRO-ACT) platform allows merging of data from existing public and private sources of completed Phase II and III trials. Data mining of PRO-ACT is expected to lead to the identification of disease biomarkers, provide insight into the natural history of disease, as well as insights into the design and interpretation of clinical trials.

3:00 Advancing Translational Research through Web-Portal Access to Clinical Trials Data, Analyses and Bio-Repository Information

Adam Asare, Ph.D., Senior Director, Data Analysis & Data Management, Biomarker & Discovery Research, Immune Tolerance Network

The Immune Tolerance Network has developed ITN TrialShare, a web portal application providing research collaborators access to clinical, research assay and specimen data along with tools for data visualization and collaborations. Hear lessons learned from committing to an open source software framework and ongoing challenges with clinical trials and research assay data management.

3:30 The Image Collaborative Portal: A Distributed Solution Driving Substantial Cost Savings in Managing Imaging Clinical Trials

Jay Bergeron, Senior Manager, Translational and Bioinformatics, Pfizer, Inc.

Collecting medical images from multi-site clinical trials requires coordination across acquisition sites, safety monitors, and sponsors. The Image Collaborative Portal substantially contains costs by alleviating the need for a CRO image custodian. Learn how this distributed approach to image study management via cloud services, presents a new scalable, extensible and cost effective model for study conduct.

4:00 Conference Adjourns

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