San Francisco Bay Area Biometrics Consulting
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San Francisco Bay Area Biometrics Consulting

Biometrics Solutions


Biostatistics and Statistical Programming

Biostatistics and statistical programming have become essential components of modern clinical trial research.  Clindata Insight provides industry-leading expertise in biostatistics and statistical programming.  Our team has nearly 20 years of biostatistics and statistical programming experience, over 10 years of CDISC experience, in-depth knowledge of therapeutic areas (e.g., oncology) and experience in Phases 1 to 4, which allows for on-time, high quality deliverables.   Clindata Insight support includes:

•    Statistical sections of protocol
•    Statistical analysis plan (SAP)
•    Power and sample size calculations
•    SDTM annotated CRF
•    SDTM
•    ADaM
•    Define.xml
•    Reviewer Guide (i.e., SDRG and ADRG)
•    TFL
•    ISS/ISE
•    Patient profile
•    Ad Hoc analysis

We pride ourselves on being there for your biostatistics and statistical programming needs every step of the way.  Team up with Clindata Insight for the most efficient and complete final product in timely delivery of your New Drug Application (NDA), Independent New Drug (IND) application and Biologic License Application(BLA).


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26 August 2016
  On August 5, 2016, FDA released a new version of the Study Data Technical Conformance Guide v...
14 February 2017
Join us at the next PhUSE SDE in Foster City CA Theme: "Programming on Steroids” – Utilizing Advance...
20 December 2016
We are excited to share the news that we have been certified in December 2016 as a Women's Business ...
14 February 2017
Berkeley Statistics Annual Research Symposium (BSTARS) The Berkeley Statistics Annual Research Sympo...

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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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