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Electronic Health Records (EHR) [clear filter]
Monday, June 27
 

8:30am EDT

#102: Digital Health Debate
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

The Digital Debate will bring together expert representatives from sponsor, site, CRO and marketing perspectives to debate the merits of digital media for patient recruitment and retention. We will discuss the challenges and optimal scenarios for utilizing digital channels to recruit patients.

Learning Objectives

Discuss insights from sponsors, CROs, and sites on their past and planned use of digital media for patient recruitment; Describe the challenges faced in implementing digital media for patient recruitment; Address issues in coordinating digital media campaigns among the entities and in integrating digital with traditional campaigns; Identify possible methods to overcome organizational barriers to effectively implement digital campaigns for patient recruitment.

Chair

Nariman Nasser

Speaker

Move from Pilot to Platform: Four Strategies to Enable Digital Health Approaches to Scale in Research Programs
John Reites

mHealth in Clinical Research and Development: Is It All Hype?
Brett Villagrand

Site Perspective
Joshua R. Korzenik, MD



Chair
avatar for Nariman Nasser

Nariman Nasser

Digital Strategist, Operational Intelligence and Innovation, Roche
Nariman Nasser is Digital Strategist of Operational Intelligence and Innovation at Roche/Genentech. She previously was the Senior Director of Participant Recruitment & Study Management Services at UCSF's Clinical & Translational Science Institute. Ms. Nasser’s prior experience also... Read More →

Speakers
JK

Joshua Korzenik

Director, Crohn's and Colitis Center, Brigham and Women's Hospital
avatar for John Reites

John Reites

Senior Director, Head of Digital Health Acceleration, Quintiles Inc.
As the Head of Digital Health Acceleration, John Reites is focused on partnering and executing digital health innovation programs with biopharmaceutical companies, established innovators, start-ups and VC firms. Mr. Reites is a speaker and author of various publications, providing... Read More →
avatar for Brett Villagrand

Brett Villagrand

Principal, Carethings
Brett’s passion is for how innovation in technology can impact outcomes for patients. Most of his career was with Pharmaceutical companies Novartis and Genentech in product development and marketing roles. Until recently, was hired as an industry subject matter expert at Oracle... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Forum

8:30am EDT

#109: EHR in Clinical Research: Heralding a New Era
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will focus on the work completed by the CDISC EHR-to-CDASH (E2C) team mapping data from EHR into EDC as eSource. Ongoing studies will be profiled. Representatives from a sponsor, academia, and EDC vendor will present.

Learning Objectives

Identify the components of EHR systems; Discuss complexities associated with EHR to EDC data transfer; Describe data standards and proper mapping between systems; Describe regulatory implications; Discuss how this will be able to help clinical research sites.

Chair

Trisha D Simpson

Speaker

EHR to EDC Data Transfer: Experiences and Lessons
Ian Sparks

The eSource Stakeholders Group and Next Steps
Michael A. Ibara, PharmD

EHR-EDC Integration Case Study: The Good, the Bad, and the Beautiful
Sue Dubman, MA



Chair
avatar for Trisha Simpson

Trisha Simpson

Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval... Read More →

Speakers
avatar for Sue Dubman

Sue Dubman

Director, IT and Informatics Innovation, University of California San Francisco (UCSF)
20+ yrs. experience. Sr. Dir, IT Innovation, at UCSF. Part of a multi-disciplinary team to innovate changes in care & research. Previously Sue was Sr. Dir, Genzyme, strategy, standards and arch. Before that, served as Dir, NCI Informatics Initiatives & VP/CIO at 2 biopharmas. At NCI... Read More →
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
avatar for Ian Sparks

Ian Sparks

Senior Director, Research Science, Medidata Solutions Worldwide
Ian Sparks is a Senior Director in Medidata Labs, an innovation group focused on evaluating new technologies and data integrations. Ian's recent work has been in integrating wearable sensors and Electronic Health Records with EDC using CDISC and HL7 standards. Ian holds a bachelors... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

10:45am EDT

#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-535-L04-P; CME 1.25; IACET 1.25; RN 1.25

The ADAPTABLE study, started in 2015, is the largest virtual study ever done in the clinical research industry. Speakers will review the lessons learned from establishing a technology process suited for 20,000 remote patients on this study.

Learning Objectives

Demonstrate a working knowledge of implementing remote consenting; Discuss updates on recent guidance documents and regulatory approvals for virtual data collection.

Chair

Anthony Costello

Speaker

ADAPTABLE: A 20,000 Patient Study Leveraging Health Systems, EHR, and Patients to Transform Clinical Research
Adrian Hernandez

REACHnet’s Recruitment for the ADAPTABLE Virtual Trial Using Technology at the Point-of-Care
Elizabeth Nauman



Chair
AC

Anthony Costello

Chief Executive Officer, Mytrus, Inc.
Anthony Costello: Co-Founder and CEO of Mytrus has co-founded many clinical & hi-tech start-up companies in N. CA. He was selected as PharmaVoice Top 100 Most Inspiring People in Clinical Research, served as Chairman of the Board for the Society for Clinical Data Management, on founding... Read More →

Speakers
AH

Adrian Hernandez

Co-Private Investigator, PCORnet Coordinating Center, Professor of Medicine, Duke Clinical Research Institute (DCRI)
Dr. Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Faculty Associate Director of the Duke Clinical Research Institute and Director of the Health Services and Outcomes Research... Read More →
avatar for Elizabeth Nauman

Elizabeth Nauman

Research Director, Research Action for Health Network (REACHnet), Louisiana Public Health Institute (LPHI)
As REACHnet's Research Director, Dr. Nauman works with a multi-institutional team to develop and optimize the informatics and technology infrastructures as well as stakeholder engagement to support efficient pragmatic clinical research. She leads the development of the network’s... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

10:45am EDT

#141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will define the strategic importance of the PCORnet Common Data Model in the use of electronic health records(EHR) and health plan data for research, its key role in the ADAPTABLE pragmatic trial, and how these experiences are generalizable to other stakeholders.

Learning Objectives

Assess the opportunities and challenges of using electronic health data for clinical research, including data management processes, coordinating center practices, and data quality; Describe the strategic role and development of a common data model for a national distributed research network; Evaluate the application of a common data model in the design of a pragmatic clinical trial.

Chair

Shelley Rusincovitch

Speaker

Leveraging a Common Data Model for a Pragmatic Clinical Trial in a Distributed Research Network: The PCORnet ADAPTABLE Study
Lesley H. Curtis, PhD

A Common Data Model and Diversity of Stakeholder Beliefs: How Do You Know What You Actually Know, Collectively?
Aaron Sorensen, MA

Applying the PCORnet Common Data Model to the EHR Ancillary Study of the HARMONY Trial: Strategy and Design Considerations
Carol E Koro, PhD



Chair
avatar for Shelley Rusincovitch

Shelley Rusincovitch

Project Leader in Applied Informatics and Architecture, Duke Translational Research Institute
Shelley Rusincovitch is a Project Leader in Applied Informatics & Architecture with the Duke Translational Research Institute (DTRI), with highly-technical experience in database programming, clinical trials, outcomes registries, and health system data warehousing. Her responsibilities... Read More →

Speakers
avatar for Lesley Curtis

Lesley Curtis

Professor of Medicine; Director, Center for Pragmatic Health Systems Research, Duke Clinical Research Institute (DCRI)
A health services researcher by training, Dr. Curtis oversees a portfolio of projects that use observational data to address questions related to clinical and comparative effectiveness, pharmacoepidemiology, health care delivery, and epidemiological trends. Dr. Curtis has considerable... Read More →
avatar for Carol Koro

Carol Koro

Senior Director, Worldwide Epidemiology, GlaxoSmithKline
Carol Koro currently works for GSK, focusing on metabolic and cardiovascular epidemiologic research. Dr. Koro has a PhD in Pharmaceutical Health Services Research from the University of Maryland and is a PA licensed pharmacist. She has done extensive research on the safety of diabetes... Read More →
avatar for Aaron Sorensen

Aaron Sorensen

Director, Data Science Insights, Digital Science


Monday June 27, 2016 10:45am - 12:00pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am EDT

#313: The Future of Clinical Research Data: 2020 and Beyond
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will engage a panel of experts who will discuss current and emerging opportunities and trends in the representation and use of research data and describe a future vision for capitalizing on these to improve the future research process.

Learning Objectives

Describe current state, trends and opportunities such as data transparency, electronic health records, interoperability, wearable technologies, regulatory science, data standards and analytics; Describe a vision for future clinical research data systems and processes that can logically evolve from the current state to meet these requirements including opportunities to improve the research process.

Chair

Wayne R. Kubick, MBA

Speaker

Panelist
Dave Evans, MS

Panelist
Armando Oliva, MD

Panelist
Kenneth A. Getz, MBA



Chair
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →

Speakers
avatar for Dave Evans

Dave Evans

Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →
avatar for Armando Oliva

Armando Oliva

President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

eSource, in the sense of capturing source data for clinical trials directly from the EHR, holds great promise for improving speed, quality and efficiency in research. FDA, CDISC, and participating organizations will describe ongoing work.

Learning Objectives

Discuss an eSource implementation and its expected effect on data quality and efficiencies; Describe current work now underway in eSource with various organizations; Evaluate the readiness of your organization to implement eSource.

Chair

Michael A. Ibara, PharmD

Speaker

Academic Perspective
Amy Harris Nordo

Current FDA eSource Demonstration Projects and Overall Effort
Mitra Rocca, MSc

EHR Pilot Study: Lessons Learned Thus Far
Trisha D Simpson



Chair
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →

Speakers
avatar for Amy Nordo

Amy Nordo

Product Manager, Maestro Care (Epic) for Research and eSource, Duke University
Amy Nordo RN/BSN, CPHQ, LNC, MMCi is a Product Manager for Duke University’s Office of Research Informatics. Amy draws upon her previous experience as critical care nurse, clinical research coordinator, healthcare quality professional and Epic credentialed trainer. In her current... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →
avatar for Trisha Simpson

Trisha Simpson

Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session