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Kevin Lee to Speak at NJ CDISC Meeting on Standards Driven Oncology Studies (Response Criteria, CDISC)

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Kevin Lee, Director of Data Science at Clindata, has been invited to speak at the next New Jersey CDISC Users Group at Novartis Pharmaceuticals in East Hanover, New Jersey on February 27, 2017.  Registration is available through February 10, 2017.  Come hear him and others share the latest knowledge on CDISC.


Proposed Agenda

  1. What’s new in SDTM 1.5 – Mike DiGiantomasso (Pinancle)
  2. Demo on creating ARM using P21E - Max Kanevsky (Pinnacle)
  3. Practical considerations for data validation - Sergiy Sirichenko (Pinnacle)
  4. Break: Networking opportunity, refreshments would be provided.
  5. eSub Ready: ADaM metadata creation to Define.xml creation – Mominul Islam (Novartis)
  6. Standards driven Oncology Studies (Response Criteria, CDISC) – Kevin Lee (Clindata Insight)



  • Novartis Pharmaceuticals Corporation, East Hanover campus.
  •   Monday, 27 February 2017
  •   Monday, 27 February 2017
  • 1:00 PM EST - 5:00 PM EST
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PhUSE Single Day Event Foster City CA

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Join us at the next PhUSE SDE in Foster City CA


"Programming on Steroids” – Utilizing Advanced Programming Techniques to Break through the Constraints of Time, Cost and Quality.


There are underlying patterns in what we do which foster opportunities to write highly reusable code that can apply across studies and therapeutic areas. Break out of the silos we build around single-process thinking and single-use programming. Expand your vision! Take a look at the world of meta-programming and metadata design through the experience of leaders in our industry and others.

See how creativity in this area can drastically improve performance across the board:

  • Reduce the amount of code required to be invented or tweaked from study to study
  • Improve quality of programs and deliverables
  • Decrease time required for study programming
  • Improve transparency and traceability
  • Increase your focus on the data instead of the programming
  • Ultimately make your job fun and rewarding

The advancement of clinical trials promises to bring more data, more standards and more complexity. We simply have to adjust our thinking processes and strengthen our core programming techniques in order to adapt and keep up with all that is coming. The discussions at this event will bring an alternate perspective on programming design and techniques that may completely transform the old ways and shed light on a new path for programming in our future reality.





8.00 - 9.00am Welcome Refreshments  
9.00 - 9.15am Keynote Amy Caron,
Gilead Sciences
9.15 - 10.00am The Next Logical Step... Meta-programming Greg Steffens,
Noumena Solutions
10.00 - 10.30am Managing Files in Compliance with 21 CFR Part 11 – Today's Options Frank Senk,
GCE Solutions
10.30 - 11.00am Morning Break  
11.00 - 11.30am Using Text-mining Techniques to Explore Submission Data – An Update Skip Francis,
11.30 - 12.00pm Protocol Buffers

Manojav Patil,
Google Inc.

12.00 - 1.00pm Lunch & Networking  
1.00 - 1.30pm Best of Both Worlds: Better Team Management and Higher Quality Deliverables Sunil Gupta,
1.30 - 2.00pm Data Visualization Applications Using R/Shiny Brian Munneke,
2.00 - 2.30pm Afternoon Break & PhUSE 100th SDE Celebration  
2.30 - 3.00pm Standardized Approach to Create Visualizations for Clinical Trial Study Data Review Catherine Xiao,
Gilead Sciences
3.00 - 3.30pm PhUSE CSS Emerging Trends and Technology Update: Educating for the Future Ian Fleming,

3.30 - 4.00pm

Panel Discussion & Wrap-up



  •   Thursday, 23 February 2017
  •   Thursday, 23 February 2017
  • PhUSE
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DahShu 2017 Symposium Computational Precision Health

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Please join us at the DahShu 2017 Data Science and Computational Precision Health.

The theme for this year's conference is "Data Science and Computational Precision Health." It will be an international forum that includes keynote speeches, invited talks, demonstrations, as well as oral and poster presentations of papers. The goal is to explore research, development and novel applications in the field of medical research and data science that actively promotes precision health. In this era of information explosion, great advancement to understand disease and help patients could only be achieved by successful collaborations. We aim to bring together academia, industry and policy makers into the same room to share knowledge and experiences, and to showcase innovations and achievements.


  • South San Francisco Conference Center
  •   Monday, 20 February 2017
  •   Wednesday, 22 February 2017
  • DahShu
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Clindata Proud to Sponsor the SF Bay Area CDISC Meeting

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Clindata is proud to sponsor the next SF Bay Area CDISC meeting being held on February 9, 2017 at 12:30-4:30 PM at the South San Francisco Conference Center.

Scheduled as one of the speakers will be our very own Kevin Lee, Director of Data Science at Clindata.  His presentation is on

How Will The New FDA Technical Rejection Criteria and Rejection Process Impact CDISC Data Submissions

Beginning Dec 18, 2016, all clinical trial and nonclinical trial studies must use standards (e.g., CDISC) for submission data and beginning May 5, 2017, NDA, ANDA, and BLA submissions must follow eCTD format for submission documents.   In order to enforce these standards mandates, the FDA also released "Technical Rejection Criteria for Study Data" in FDA eCTD website on October 3, 2016.  FDA also implemented a rejection process for submissions that do not conform to the required study data standards.

The presentation will discuss how these new FDA mandates impact the electronic submission and the required preparation for CDISC and eCTD complaint submission package such as SDTM, ADaM, Define.xml, SDTM annotated eCRF, SDRG, ADRG and SAS programs.   The presentation will introduce the current FDA submission process, including the current FDA rejection processes – “Technical Rejection” and “Refuse-to-File”.  It will also demonstrate how FDA has used “Technical Rejection” and “Refuse-to-File” to reject submission.  The presentation will show how FDA plan to use “Technical Rejection Criteria for Study Data” for non-CDISC data submission.   The presentation will also discuss how the rejection will impact sponsor’s submission process, and how sponsors should respond to FDA rejections as well as questions throughout the whole submission process.   Use cases will demonstrate the key technical rejection criteria that will have the greatest impact on a successful submission process.

Other speakers will be there to share their latest knowledge and expertise in the CDISC area.



  • South San Francisco Conference Center
  •   Thursday, 09 February 2017
  • 12:30 - 4:30 PM
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WUSS 2016 Educational Forum and Conference, September 7-9

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Our team will be at WUSS 2016 Educational Forum and Conference.  Please come by and say hello.

When: Sept 7-9, 2016

Where: The Grand Hyatt on Union Square, San Francisco CA

To register online for this event, please go here: Registration

For more information on WUSS 2016 please click here: WUSS2016

WUSS, Inc. is the officially recognized SAS User Group of the Western Region of the United States. The WUSS region includes Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, Oregon, Utah, Washington, and Wyoming.

This non-profit, educational organization exists to provide SAS System users a forum for the exchange of ideas and to provide professional development opportunities for SAS users.

We encourage all SAS users to participate in the educational, training and networking opportunities that we provide, primarily via the annual WUSS conference.

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