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Video: Let's Make Oncology Studies Easy for Programmers and Statisticians

B2ap3 Large Lets Make Oncology Studies Easy For Programmers And Statisticians
The World Health Organization (WHO) predicts that new cancer cases will increase from 14 million in 2012 to 22 million in 2030 and cancer deaths will increase from 8.2 million to 13 million annually.   In addition, oncology revenue from the pharmaceutical industry is expected to increase to $150 billion by 2020 from $107 billion in 2015. Almost all pharmaceutical companies are invested in bringing innovative oncology drugs to market, so the demand for oncology-experienced programmers and statisticians has also increased.   
Compared to other therapeutic studies however, oncology studies are complex and difficult for programmers and statisticians. In particular, oncology studies require a specific way for data collection and analysis. In this webinar, we will take a look at how oncology studies differ from other therapeutic studies, and how oncology-specific data collections and analysis must be conducted.

 Through this webinar, programmers and statisticians will learn the following:

  • Three Oncology Sub-types - Solid Tumor, Lymphoma and Leukemia
  • Response Criteria Guideline - RECIST for Solid tumor, Cheson for Lymphoma and IWCLL for Chronic Lymphocytic Leukemia
  • Data Collections Based on Response Criteria
  • CDISC SDTM Tumor Domains - TR, TU, RS
  • Tumor Response - Complete Response, Partial Response, Stable Disease and Progression Disease
  • CDISC Time to Event ADaM Datasets
  • Events and Censoring
  • Oncology-specific Analysis - Overall Survival, Progression Free Survival, Overall Response Rate  


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We are now a WBENC certified Women's Business Enterprise WBE

B2ap3 Large WBENC Certified Feature Image For Social

We are excited to share the news that we have been certified in December 2016 as a Women's Business Enterprise (WBE) through the Women's Business Enterprise National Council (WBENC), the nation's largest third party certifier of businesses owned and operated by women in the US.  We recognize the commitment to supplier diversity that is embraced by corporations and government agencies today, and we can add diversity to your supply chain.

Clindata Insight is a biometrics consulting firm based in the San Francisco Bay Area specializing in biostatistics, statistical programming, CDISC implementation, big data for life science and talent solutions. We support biopharma, medical devices and molecular diagnostic companies in Phase I to Phase III clinical trials and deliver actionable insights from their data to enable evidence-based business decisions. We have seasoned consultants with many years of direct new drug submission experience with FDA, EMA and PMDA. Our therapeutic area encompasses oncology, hematology, liver disease, metabolic disease, ophthalmology, inflammation and dermatology.



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Webinar video: How Will the New FDA Technical Rejection Criteria and Rejection Process Impact CDISC Data Submissions? Presented by Kevin Lee, Director of Data Science

B2ap3 Large Webinar Fda Tec 18358891 Ea8be94a870b3ef13c1ce30fe74efd56c82afea6
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Are Trial Design Domains optional in a CDISC-compliant e-submission to FDA? by Peng Yang

B2ap3 Large FDA Conformance Guide 3.1


On August 5, 2016, FDA released a new version of the Study Data Technical Conformance Guide version 3.1 (Guide).  This Guide provides technical specifications, recommendations, and general considerations on how to submit standardized electronic study data using FDA-supported data standards located in the FDA Data Standards Catalog (Standards Catalog).  As always, anyone who is going to be involved in submission data preparation should study the entire Guide thoroughly. We would like to discuss one important issue that is often overlooked, which is the decision to include Trial Design Domains in an e-submission.

Emphasizing Trial Design Model in SDTM and SEND

FDA emphasizes the importance of Trial Design Model (TDM) which includes Trial Arms, Trial Elements, Trial Visit, Trial Inclusion/Exclusion Criteria, Trial Summary and Trial Disease Assessment.   FDA strongly recommends that sponsors should include Trial Summary (TS) even for legacy studies.  What is the unique about TS is that the study start date (SSTDTC in TS.TSPARMCD) in the TS domain will determine whether a given study needs to use a particular data standards as specified in Standards Catalog.  The requirement for providing TS domain for NDA/BLA was also made clear by FDA at the 2016 FDA/PHUSE Computational Science Symposium (CSS).  Therefore, it is a must-have, not a nice-to-have item. In SEND submission, all the Trial Design domains should be included as well.

Data for building Trial Design Domains may not in the EDC raw data

We have noticed that one common reason for people to push back on creating TDM is that the source data are not in the EDC database. Some are actually from protocol and sometimes it is unclear whose responsibilities it is to build these domains.   At Clindata Insight, when we review CRO deliverables as part of our CRO Oversight consulting service, we pay special attention to check the deliverables against FDA’s requirements such as what is included in this Guide.   We strongly urge sponsor companies to use this Guide to evaluate their CRO’s knowledge of supporting CDISC compliant submission. A quality vendor should have thorough understanding of the Guide and provide solid adherence to the Guide.

If you have any questions regarding preparing standardized data for your FDA submission, please contact us at .

#NDA #BLA #CDISC #SDTM #SEND #submission

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What Kevin Durant teaches us about talents in Biometrics Department? by Kevin Lee

B2ap3 Large Kevin Durant In Golden State Warriors 2

Kevin Durant, one of the best basketball players in the NBA, decided to forgo more money and a comfortable situation in Oklahoma to join the Golden State Warriors.  I was stunned to hear that news.  I thought that knowing his situation, he would stay in Oklahoma.  He could get more than $150 million over 5 years in Oklahoma, but he took less money to join the Warriors team.  Why?  Why did he leave his once-called home and take less money to play in another city?  The answer is very simple.  He wants to win.  He wants to WIN NOW.  

As a professional myself, I understand why he joined the Warriors.  The Golden State Warriors are considered the best basketball team.  The winning culture, potential teammates like Steve Curry and an exceptional coach in Steve Kerr, will contribute to Kevin Durant’s winning edge.  Nobody doubts that Steve Curry and the Warriors team will be able to work with Kevin Durant.  There is no ego in this team.  In other words, the Golden State Warriors were able to get Kevin Durant because of who they are.
This somewhat astonishing news teaches me about bringing new talent to our company and to our clients in the pharma industry.  Sometimes, we wonder why we can’t get a great candidate to take what seems like a perfect job.  Should we pay more money?  Should we give more perks?
Maybe we should think like Kevin Durant and ask ourselves.  Are we a winning team?  Do we have a great culture that can attract the best talents?  Do we have what it takes to make the candidate feel successful by just saying “yes” to the job?  We should turn the questions around and ask ourselves what makes us a winning team.  The best talents in any industry want to WIN.  They simply want to join the winning team.
Clindata Insight recognizes the importance of building the best and most talented teams for Biometrics department.  We are proactive and introspective with the goal of doing what it takes to build a winning team.

If you want to win now, please contact us at


Kevin Lee is the Director of Data Science at Clindata Insight. He has been part of the pharmaceutical industry for more than 15 years with experience as a statistician, CDISC consultant, statistical programmer, and a project and industry thought leader within the clinical trial domain.

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Kevin Lee
17 May 2016
The Food and Drug Administration (FDA) recently published version 3.0 of the Technical Conformance ...
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26 August 2016
  On August 5, 2016, FDA released a new version of the Study Data Technical Conformance Guide v...
19 January 2017
Clindata is proud to sponsor the next SF Bay Area CDISC meeting being held on February 9, 2017 at 12...

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