Trk 07: Tech-Data- Records-Subs [
clear filter]
8:30am EDT
#109: EHR in Clinical Research: Heralding a New Era
Chair
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...
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Speakers
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...
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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...
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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...
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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
- Credit Type CME, IACET, RN
- Audience Intermediate
- Featured Topics Electronic Health Records (EHR)
- Interest Area eClinical, Clinical Data Management, Regulatory Affairs, Information Technology
- format json
- Interest Area eClinical,Clinical Data Management,Regulatory Affairs,Information Technology
- Featured Topics Electronic Health Records (EHR)
- Credit Type CME, IACET, RN
- Tags 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
Chair AC
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...
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Speakers AH
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...
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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...
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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
- Credit Type ACPE, CME, IACET, RN
- Audience Basic
- Featured Topics Clinical Trial Designs, Big Data, Electronic Health Records (EHR), Increasing Research and Development Innovation, Value-Based Evidence
- Interest Area eClinical, Clinical Research, Comparative Effectiveness
- format json
- Interest Area eClinical,Clinical Research,Comparative Effectiveness
- Featured Topics Clinical Trial Designs,Big Data,Electronic Health Records (EHR),Increasing Research and Development Innovation,Value-Based Evidence
- Credit Type ACPE, CME, IACET, RN
- Tags Session
2:00pm EDT
#240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards
Chair
Vice President, Development Opportunities, CDISC
Rhonda Facile has over 25 years of clinical operations experience. She has worked in a global CRO, pharmaceutical and biotechnology companies both in the United States and abroad. She has experience in clinical trial monitoring, project management, regulatory affairs and standards...
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Speakers
Senior Informatics Advisor, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions...
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President, Maximum Likelihood, Inc.
Susan is a biostatistician with 20 years of experience in research for public health and for the pharmaceutical industry. She has been active in CDISC since 2000 and is a senior team member of ADaM. Her areas of interest included CDISC implmentation strategies and graphical methods...
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Director, Concept Modeling, CDISC
Diane Wold received her PhD in Statistics from UNC-Chapel Hill. She joined Burroughs Wellcome in 1984 as a project statistician held a variety of positions, leading to her current role in Data Standards at GSK. Since 2002, she has been active in CDISC, and currently provides consultation...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#263: Patient Centricity in Clinical Trials
Chair DB
Chief Technology Officer, eClinicalHealth Ltd
Doug Bain, Founder and Co-CEO & CTO of eClinicalHealth Ltd,, has been involved in the development, deployment and optimization of eClinical technologies since 1996. eClinicalHealth provides the high performance cloud driven clinical trial solutions - Clinpal - for end-to-end clinical...
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Speakers
Executive Consultant, Clinical Operations, Myokardia, Inc.
Bruno is a Clinical Operations Opinion Leader with over 24 years of experience in clinical trial management. His consulting practice has a focus on building capabilities in clinical trial execution. Bruno develops solution for his biotech clients around site selection, optimization...
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Director of Product Strategy - Digital Patient, ERT
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
201B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#341: eTMF: Selection, Implementation, and What's Next?
Chair
Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as...
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Speakers MD
Senior GCPM ONC, eTMF Process Owner Representative, Bayer Pharma AG
Dr. Martina Duevel eTMF Process Owner Representative, Bayer In the pharmaceutical industry for 16 years with roles in QA and Clinical Project Management. Project Lead for eTMF implementation and maturation, and Process Owner Representative for internal oversight and vendor govern...
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Director, Global Quality Assurance, MakroCare
Wednesday June 29, 2016 2:00pm - 3:00pm EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Session
- Credit Type CME, IACET, RN
- Audience Intermediate
- Featured Topics Clinical Trial Transparency-Clinical Trial Disclos
- Interest Area Document & Records Management, Clinical Data Management, Regulatory Affairs, Clinical Research
- format json
- Interest Area Document & Records Management,Clinical Data Management,Regulatory Affairs,Clinical Research
- Featured Topics Clinical Trial Transparency/Clinical Trial Disclos
- Credit Type CME, IACET, RN
- Tags Session
4:00pm EDT
#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
Chair
Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the DIA...
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Speakers
Product Manager, CluePoints
Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-authored...
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Senior Manager, Product Management, Oracle Health Sciences
Senior Manager in Oracle Health Sciences Product Management organization, responsible for providing product leadership on current market leading Clinical Data Acquisition and Management products. Prior to Oracle, worked at Phase Forward and led delivery of large scale technology adoption...
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Director, Data Management, Target Health Inc.
Dr. Tansyura has 15+ years of pharmaceutical experience, including a Head of DM role at Regeneron, Infinity and Cincinnati Children's Hospital. Dr. Tantsyura is a co-founder and member of the Advisory Board for OpenCDISC (2008-2010) and SCDM board member (2014-2016). Dr. Tantsyura...
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Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Risk-Based Monitoring
- Interest Area Clinical Data Management, Regulatory Affairs, QA-QC, eClinical
- format json
- Interest Area Clinical Data Management,Regulatory Affairs,QA/QC,eClinical
- Featured Topics Risk-Based Monitoring
- Credit Type ACPE, CME, IACET, RN
- Tags Session
10:45am EDT
#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
Chair
Senior Innovation Project Manager, PPD
John Bunch is a PMP, Six Sigma, and Proci certified project manager now focused on pharmaceutical and CRO innovation projects intended to positively impact patient trial experience, improve data frequency and reliability, and bend the cost time curve for drug development. Mr. Bunch...
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Speakers
Work Stream Leader Mobile Patient Data, Novartis Pharma AG
Tilo's career career started in Roche, developing and implementing large corporate IT platforms for more than 50'000 employees. Since 2003, he had positions with increasing responsibility in Novartis IT and Sourcing, for example to operate the global Personal Computer environment...
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Director, Business Development, Qualcomm Life
Yury Rozenman leads Qualcomm Life pharmaceutical business development organization. Yury has considerable experience of working in and consulting to the pharmaceutical industry, strategic studies, new product and business development and manufacturing across the healthcare and life...
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Thursday June 30, 2016 10:45am - 11:45am EDT
111AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Clinical Trial Designs, Disruptive Technologies, Patient Engagement, Mobile-Wearable Technology
- Interest Area eClinical, Clinical Data Management, Public Policy - Health Care Compliance - Law, Regulatory Affairs, Clinical Research, Information Technology
- Tags Session
10:45am EDT
#408: Securing Internet-Driven Collaboration in Drug Development
Chair
President and Chief Executive Officer, Safe-BioPharma Association
The SAFE-BioPharma standard assures the identity trust inherent in implementation of the TransCelerate Shared Investigator Portal, in Merck’s EngageZone portal, and in other industry collaboration portals. Digital signature applications certified compliant with the SAFE-BioPharma...
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Speakers
Director of Enterprise Architecture, IT Planning & Innovation, Applied Tech, Merck & Co., Inc.
His expertise includes creating the architectures for Identity and Access Management (IAM) and Enterprise Knowledge Management (EKM) solutions that support Merck's External Partner Program (EPP) and clinical trials initiatives. Mr. Porter has also provided architectural alignment...
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Thursday June 30, 2016 10:45am - 11:45am EDT
109AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA