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eyeforpharma Data and Technology in Clinical Trials 2017 Summit

Join Sam Hume, Head of Data Exchange Technologies, CDISC, at eyeforpharma’s Data and Technology in Clinical Trials 2017 Summit. He will be participating on a panel discussion with other thought leaders in the clinical space including Raj Nimmagadda, Global Head of Clinical Data Sciences & Standards Implementation, Novartis and Jeremy Wyatt, CTO & Sr. VP of Product Development, ActiGraph, to discuss best practice for data collection and how this will enable your organisation to make faster and better informed decisions.

Sam will also be presenting on the “beginning to end” project, which will help you see your clinical trial data as one continuous lifecycle. His discussion will touch upon several important themes, including:

  • Learn how CDISC SHARE contributes to the availability of standards that work together across the clinical research data lifecycle
  • Learn how to improve traceability across the full clinical research data lifecycle to include useful visualizations
  • Hear about the important work CDISC has been doing on the CTR-XML standard to more efficiently submit to clinical trial registries

Discount code: CDISC200 – Using this code when booking will save $200 off the listed price of a pass

SEND Fit for Use Pilot Discussions

Fit for Use Workstream Status

The CDISC SEND Team, in collaboration with the PhUSE Nonclinical Test Submission Forum Team, will be sharing the current status of the SEND usability pilot, the “Fit for Use” submission pilot. 

October 26, 2016 4:00 – 5:00PM EDT

To join this web conference, please use connection information at the SEND Fit for Use public wiki: http://wiki.cdisc.org/display/NSFFUW/Nonclinical+%28SEND%29+Fit+for+Use+Workstream+Home

Open to the Public - Please note this conference call is limited to 100 attendees.

SEND-compliant Dataset Submission Process and Nonclinical Test Submissions Discussions with FDA EData Team

The CDISC SEND Team is holding a discussion with the FDA EData Team regarding SEND-compliant dataset submission process and nonclinical test submissions, in general. This will also include some discussion related to the recent CDER SBIA Webinar: “Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria”.  

October 27, 2016 11:00 AM – 12:00 PM EDT

Open to the Public - Please note this conference call is limited to 100 attendees.

To join this web conference, please use connection information at the SEND Fit for Use public wiki: http://wiki.cdisc.org/display/NSFFUW/Nonclinical+%28SEND%29+Fit+for+Use+Workstream+Home

The San Diego CDISC Users Network (SDCUN) Meeting on 13 December 2012


Location: Pfizer in La Jolla

Time: 12:00 PM to 4:00 PM


Location: Pfizer in La Jolla

Time: 12:00 PM to 4:00 PM



The San Diego CDISC Users Network (SDCUN), is a network that encourages sharing of experiences, education, exchange of ideas, news and career opportunities amongst friends and colleagues in our industry who share an interest in CDISC, submission standards, and regulation.


Based upon the feedback from our last meeting, we have added an additional interactive element to the meeting and are looking forward to the continued sharing and learning amongst our members. Follow the link for agenda and further details.

The End to End Clinical Data Management Conference on 21 & 22 March 2012



Be the first to discover what the future has in store for clinical data management!


The End to End Clinical Data Management conference taking place on 21st and 22nd March 2012 at the Crowne Plaza Philadelphia West, will provide the ultimate platform to network, bounce ideas off each other and ideally produce a new generation of data management experts to lead to our eventual goal: Process Optimization.


End to End Clinical Data Management is the first conference of its kind to offer solutions to the complex and frustrating challenges you face in your everyday work.


Key opinion leaders and experts in the field of clinical data management will be attending including:


  • Katherine Vandebelt, Senior Director Data Sciences and Solutions, ELI LILLY AND COMPANY Samuel Hume, Director, Astra Zeneca
  • Thomas Verish, Senior Director and Head of Data Management, Programming & CSR Writing, PFIZER
  • Andrew Cwiertniewicz, Senior Clinical Trial Manager Clinical Operations, Sanofi Pasteur
  • Carol Ann Schaffer, Project Data Manager Hoffmann, La Roche
  • Darlene Kalinowski, Associate Director EDC Operations, Bristol Myers Squibb ….and many more!


At a time when cost cutting is occurring everywhere, CDM is an area with a huge potential for savings through efficiency and process optimization.


For further information, please visit the Arena International Website or send an email for further questions.

DIA: Investing in Biomedical Informatics for Drug Development and Health Care

12 October - 14 October 2010

Gaylord National Hotel and Convention Center
201 Waterfront Street
National Harbor, MD 20745



THEME A – Application of Biomedical Informatics to Health Care and Pharma

  • Semantic Web
  • Clinical and Health Care Data Quality and Integrity
  • Predictive Analytics
  • Data Repository


THEME B – Policy of Biomedical Informatics in Health Care and Pharma

  • FDAAA and Comparative Effectiveness Research
  • Technology & Data Standards in Public Health
  • Meaningful Use of Electronic Health Care Records
  • FDAAA: Sentinel Initiative



  • Strategies on Developing and Deploying Semantic Linked Data to Biomedical Applications
  • Biomedical Informatics Tools for Preparing Observational Data for Active Surveillance and Outcomes Research



  • Keynote Presentation – Health Informatics by Dr. Mark B. McClellan, Director, Engelberg Center for Health Care Reform, Senior Fellow, Economic Studies, and Leonard D. Schaeffer Chair in Health Policy Studies, The Brookings Institution
  • Keynote Presentation - Integrative Informatics in R&D by Dr. John Reynders, Head of Integrative Neuroscience and Head Informatics Center of Excellence, Janssen Pharmaceutical Companies of Johnson and Johnson 
  • Regulatory/Pharma/Health Care Interactive Panel featuring Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA, and Dr. Mark B. McClellan



  • Ron Fitzmartin, PhD, MBA, Senior Principal Consultant, Decision Analytics, LLC
  • Theresa Mullin, PhD, Associate Director, Planning & Informatics, CDER, FDA


Benjamin Zaitz
Phone: +1 215.293.5803

PhUSE Conference 2010, Berlin

17 - 20 October 2010


PhUSE is the worldwide voice that provides the Life Sciences industry
with the mechanism for sharing knowledge, defining and promoting
industry standards, with a view to furthering the provision of
health-care information through technology

Conference eBrochure

With the explosive growth of standards, the drive to increase efficiency and reduce costs, and the development of new and complex study designs, it is in the interests of most companies and organizations to seek solutions from innovations linked to development of the latest technologies.

  • Attend the excellent pre-conference training courses.
  • Come and hear from exciting industry leaders in the Key Note Presentations - including Dr Charles Jaffe (HL7) and Dr Rebecca Kush (CDISC).
  • Debate in the PhUSE Management Stream including presentations on Clinical Information Environments, Standardization and Business Intelligence from senior executives in companies including Novartis, GlaxoSmithKline and Accenture.
  • Join in with the PhUSE Discussion Clubs covering CDSIC, Clinical Outsourcing and Innovation through Technology.
  • Over 100 presentations across 13 streams, 4 parallel rooms and 3 days.

For more information, please visit the PhUSE Website or contact the PhUSE Office

SCDM Webinars 2011

  • 17 February: What’s New with ePRO Systems: FDA Updates and Regulations
  • 17 March: Adaptive Trial Design – What it Means for the CDM
  • 14 April: Using the CDISC Standards End-to-end in Clinical Trials
  • 19 May: Device Trial Strategies and the CDMs Role in Quality Assurance
  • 23 June: 21 CFR Part 11 for the Clinical Data Manager
  • 22 & 29 September: Biostatistics – What Every Clinical Data Manager Should Know
  • 20 October: Data Integration and the GCDMP: A New chapter in Clinical Data Management
  • 17 November: The Role of Metrics in Clinical Data Management: Tracking Quality and Efficiency

SCDM Online Courses 2011

  • 7 February - 11: March Developing Data Management Plans
  • 14 March - 8 April: Query Processing and Tracking/Database Updates
  • 11 April - 6 May: Metrics and Identifying Data Trends
  • 9 May - 13 June: Processing Lab Data 
  • 6 June - July 1: SAE Reconciliation, Safety Review and Coding
  • 19 September - 14 October: Database Lock and Randomization
  • 17 October - 11 November: Project Management for the Data Manager

HL7 24th Annual Plenary and Working Group Meeting

HL7 Banner

3-8 October, Cambridge, MA