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

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Curved
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CDISC Standards Implementation

All clinical trial studies starting after December 17th, 2016 with the exception of certain INDs will be required to have CDISC compliant data.   Any clinical trial data that is not submitted in CDISC format to the FDA can lead to a delay of submission or a “refuse to file” by the FDA.

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Clindata Insight has consultants with more than 10 years of CDISC implementation experience. Our consultants have helped develop CDISC standards as team members of ADaM, SDTM and SHARE.   They have also worked with FDA, CDISC and industry thought leaders to develop CDISC submission documents (e.g., reviewer guide) as PhUSE working group and committee member.  Clindata Insight CDISC consultants are well known in the CDISC domain and are frequently invited to speak at various conferences because of their reputation in CDISC.

Our two levels of CDISC implementation consulting services, Clindata Analysis for Strategic CDISC Implementation (CASCI), and Data Standards Submission Readiness (DASSR), will ensure that your company is FDA compliant in submission.

CASCI will help your organization achieve regulatory compliance and operational efficiency through simple, time-efficient, cost-effective steps.

•    Completing questionnaires
•    Performing current state and gap analysis
•    Finalizing a strategic direction

DASSR will certify that SDTM, ADaM, Metadata Repository, and eCTD QA are properly installed and utilized for submission readiness.  Company-wide or team specific CDISC training is also offered as a component of this consulting process.

 

Level 1:  Clindata Analysis for Strategic CDISC Implementation (CASCI)

Casci Level 1

Level 2:  Data Standards Submission Readiness (DASSR)

 Dassr Level 2

Ready to Get Started?

Schedule a No Obligation Consultation with a Clindata Insight Representative Today

Admin
14 February 2017
Berkeley Statistics Annual Research Symposium (BSTARS) The Berkeley Statistics Annual Research Sympo...
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20 December 2016
We are excited to share the news that we have been certified in December 2016 as a Women's Business ...
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28 April 2017
We are looking forward to attending PharmaSUG2017 in Baltimore, MD.  Will you join us? PharmaSU...
Kevin Lee
17 May 2016
The Food and Drug Administration (FDA) recently published version 3.0 of the Technical Conformance ...

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