San Francisco Bay Area Biometrics Consulting
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San Francisco Bay Area Biometrics Consulting
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I am the Director Business Operations for Clindata Insight, 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.

Clindata is Proud to Sponsor PKU BIO-NET Symposium 2017 in NYC

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Clindata Insight is proud to sponsor and attend the 8th PKU Bio-Net Symposium, also known as the 2017 Peking University School of Life Sciences North America Alumni Reunion. The symposium presents a perfect opportunity for the Peking University School of Life Sciences alumni living in North America to get back together. It also provides alumni of Peking University Life Sciences as well as other life sciences professionals an excellent platform for networking and sharing information regarding the latest development in the biology arena and career opportunities. The symposium will be held on Saturday July 22nd, 9 AM – 5:30 PM at Weill Cornell Medical College Uris Auditorium, New York, NY, USA.

The annual Bio-Net Symposium is a tradition honored by the Peking University School of Life Sciences alumni. Since 2009, almost every year a symposium has been organized by the undergraduate class of alumni that had graduated for 10 years. One purpose of this tradition is to strengthen relationships among the alumni. For eight years, the symposium has served Peking University alumni from all over North America as well as friends and life sciences professionals around the world. Attendees range from alumni who went to Peking University in the 1950s to young students who had recently arrived in United States. A common topic for attendees is the good old friendships formed at the beautiful campus of Peking University.

We hope to see you there!

To get more information about the event or to register to attend please visit PKU BIO-NET2017

 

EVENT DETAILS

  • Weill Cornell Medical College Uris Auditorium, New York, NY
  •   Saturday, 22 July 2017
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PharmaSUG2017 Baltimore, MD May 14-17, 2017

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We are looking forward to attending PharmaSUG2017 in Baltimore, MD.  Will you join us?

PharmaSUG is a not-to-be-missed event for programmers, statisticians, data managers, and others in the pharmaceutical, healthcare, and related industries. Our exhibit hall will feature dozens of industry-specific exhibitors, including Premier Sponsor SAS Institute. As usual, we are also offering an extensive array of pre- and post-conference training courses taught by leading industry experts to enhance your conference experience.

Conference registration is now open - click here for details!

EVENT DETAILS

  • Baltimore, MD
  •   Sunday, 14 May 2017
  •   Wednesday, 17 May 2017
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Symposium: Dose Selection for Cancer Treatment Drugs

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The goal of this workshop is to exchange research progress and discuss challenges in appropriate dosage for cancer treatments

Both academic institutions and pharmaceutical industry have conducted early phase trials to select appropriate doses for later development of cancer treatments. The increasing need for the development of combination therapy due to resistance to monotherapy and poor tolerance of approved dose regimens underscores the need for a more efficient process of dose selection in the early stages of study design and refinement through the whole cycle of drug development and post-marketing research. Furthermore, with gaining insights of pharmacology and pharmacogenomics, multidisciplinary approaches are necessary to understand the exposure-response relationships, genomic modifications, modeling and simulation for dose findings, and new design for dose-optimization studies. This symposium will bring together researchers from academia and pharmaceutical industry to exchange research progress and discuss common challenges in appropriate dosage for cancer

For conference information and registration, please click here

EVENT DETAILS

  • Stanford University
  •   Thursday, 11 May 2017
  •   Friday, 12 May 2017
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Video: Let's Make Oncology Studies Easy for Programmers and Statisticians

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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  

 

Click to View Video Here

 

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UC Berkeley Statistics Annual Research Symposium (BSTARS) 2017

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Berkeley Statistics Annual Research Symposium (BSTARS)

The Berkeley Statistics Annual Research Symposium (BSTARS) surveys the latest research developments in the department, with an emphasis on possible applications to statistical problems encountered in industry. The conference consists of keynote lectures given by faculty members, talks by PhD students about their thesis work, and presentations of industrial research by alliance members.

Schedule 

BSTARS 2017 will be March 23rd, 1:30pm-8:30pm, at The Alumni House, UC Berkeley.

1:30-2:00 Arrival, coffee, and pastries
2:00-2:10 Welcome and opening remarks
  • Michael Jordan, Statistics Department Professor and Chair
  • Frances Hellman, Dean, Math & Physical Sciences
2:10-3:10 Thunder Talks
3:10-3:30 Break
3:30-4:30 Thunder Talks 2
4:30-5:50 Poster Sessions
5:50-6:30 Keynote by Professor Jasjeet Sekhon
6:30-8:30 Dinner

EVENT DETAILS

  • The Alumni House, UC Berkeley.
  •   Thursday, 23 March 2017
  •   Thursday, 23 March 2017
  • 1:30 PM - 8:30 PM PST
  • UC Berkeley Department of Statistics
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PhUSE Computational Science Symposium March 19th - 21st 2017

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The Computational Sciences Symposium (CSS) will be celebrating its 6th annual event and has established itself as the premier collaboration within the clinical trial environment. The collaboration has continued to grow hosting the first inaugural event in Europe this past June and engaging other regulatory agencies including EMA and PMDA.

This year’s event will once again be co-sponsored by FDA and PhUSE and take place in March of 2017. The annual CSS brings together Academia, Regulators, Industry, and technology providers to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them.

The focus of the Annual Computational Science Symposium is to continue the work initiated at the previous annual meeting and throughout the year. The event will provide an update on current initiatives ongoing within the FDA, explore emerging technologies, and establish collaborative projects to address current challenges related to the access and review of data to support product development.

Working Groups

Since the 2016 CSS, the projects within the Working groups have been meeting, collaborating, and delivering valuable outputs as part of their objectives. Click here to read further information on all Working Groups, describing their projects with links to information about each one.

Over the past year, the Working Group projects have successfully delivered on their objectives to support the overall mission of the collaboration. Below are samples of those successful projects and the great work being done by many volunteers.

  • Non Clinical Study Data Reviewer’s Guide: Extension of the SDRG, a standardized template providing best practices and recommendations for non clinical information needed within a submissions
  • Analysis of Alternative Transport Formats: Survey to evaluate the requirements and needs for a more robust delivery format to regulatory agencies
  • Study Data Standardization Plan (SDSP): Development of a recommended study data standardization plan early in the development cycle to optimize implementation of data standards is the focus of this new project

In addition to the regularly scheduled activities including an opening session by the FDA, working group collaboration, poster session, and networking, other exciting activities are being planned.

Prototyping Next Generation Transport Formats

The Linked Data and Graph Databases Working Group (formerly the Semantic Technology Working Group) will be running a breakout session which will differ from previous symposiums. In addition to the project breakout sessions, the Working Group will host a separate breakout session that will build upon the Alternative Transport Format project in the Emerging Trends and Technologies Working Group and prototype next generation transport formats. This hands-on sessions will represent data in different formats including CDISC Dataset XML, the Resource Description Framework (RDF) and Neo4j property graphs. The wrap-up session will include a debrief and attempt to draw conclusions from the prototyping activity.

The Working Group welcomes anyone with CDISC business knowledge or data modeling knowledge to join the prototyping activities (i.e. you don’t need to be a technology expert). Registration for these sessions will be limited. Please indicate your interest by selecting Linked Data and Graph Databases Working Group during the registration. If you have any questions in advance, please contact Tim Williams or Scott Bahlavooni.

New Projects

The Working Group Steering Committee are accepting proposals for new projects. A proposal will address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the FDA/PhUSE collaboration.

Click here for more information and to download the New Project Request Form. New projects can be submitted at any time but there is a deadline of 31st December to be included in the 2017 meeting.

Conference Dates

The conference will commence at 4 pm on Sunday, March 19th with the opening networking session and end at 5pm on Tuesday, March 21st.

Online registration will open on November 1st. The Symposium is limited to only 300 attendees so register early before the event sells out.

EVENT DETAILS

  • Silver Springs, MD
  •   Sunday, 19 March 2017
  •   Tuesday, 21 March 2017
  • http://www.phuse.eu/css
  • PhUSE CSS
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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)

 

EVENT DETAILS

  • Novartis Pharmaceuticals Corporation, East Hanover campus.
  •   Monday, 27 February 2017
  •   Monday, 27 February 2017
  • 1:00 PM EST - 5:00 PM EST
  • https://www.survey-expert.com/web/surveyIndex.asp?U=7001001003103030398
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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

Theme:

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

Description:

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.

Agenda:

Time

Presentation

Presenter

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,
FDA
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,
Cytel
1.30 - 2.00pm Data Visualization Applications Using R/Shiny Brian Munneke,
PharmaCyclics
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,
d-Wise

3.30 - 4.00pm

Panel Discussion & Wrap-up

 

EVENT DETAILS

  •   Thursday, 23 February 2017
  •   Thursday, 23 February 2017
  • http://www.phuse.eu/single-day-events-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.

EVENT DETAILS

  • South San Francisco Conference Center
  •   Monday, 20 February 2017
  •   Wednesday, 22 February 2017
  • http://dahshu.org/events/cph2017/
  • 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.

 

EVENT DETAILS

  • South San Francisco Conference Center
  •   Thursday, 09 February 2017
  • 12:30 - 4:30 PM
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We are now a WBENC certified Women's Business Enterprise WBE

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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

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Are Trial Design Domains optional in a CDISC-compliant e-submission to FDA? by Peng Yang

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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

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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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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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PKU BIO-Net Symposium 2016

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Clindata Insight is proud to be the title sponsor for the PKU Bio-Net Symposium 2016 taking place on May 28, 2016 in San Francisco.

When: May 28, 2016

Where: Genentech Hall Auditorium, UCSF 600 16th Street, San Francisco CA

For more information or to register for the event, please go here:  PKU Bio-Net Symposium

 

This is not only an annual reunion for all Peking University alumni, but also a social gathering for anyone who is interested in biomedical-related careers. We aim to foster attendee's professional network, provide integration platform of resources, and create opportunities for collaborations.  We have invited highly recognized speakers from academia, healthcare industry, and beyond to share their experience and knowledge. 

In partnership with Peking University Alumni Association of Northern California (coordinator: Zhanzhi Hu) and PKU School of Life Sciences Alumni Association (coordinator: Chao Liu).

 

 

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Ready to Get Started?

Schedule a No Obligation Consultation with a Clindata Insight Representative Today

Admin
21 July 2016
Kevin Durant, one of the best basketball players in the NBA, decided to forgo more money and a comfo...
Peng Yang
17 May 2016
WUSS, Inc. is the officially recognized SAS User Group of the Western Region of the United States. T...
Admin
01 July 2016
Our team will be at WUSS 2016 Educational Forum and Conference.  Please come by and say hello. ...
Admin
16 May 2016
Clindata Insight is proud to be the title sponsor for the PKU Bio-Net Symposium 2016 taking place on...

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Clindata Insight Inc, provides equal employment opportunities (EEO) to all applicants for employment without regard to race, color, religion, sex, national orgin, age, disability or genetics.  In addition to federal law requirements Clindata Insight complies with applicable state and local laws governing non discrimination in employment.

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