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Data Standards Decisions - Home

Data Standards Decisions is a family owned company who specializes in data standards consultancy. Our lead consultant Gitte Frausing is an international recognized expert in the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data (CDISC SEND) model and Study Data Tabulation Model (SDTM) implementation.

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Data Standards Decisions is a family owned company who specializes in data standards consultancy. Our lead consultant Gitte Frausing is an international recognized expert in the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data (CDISC SEND) model and Study Data Tabulation Model (SDTM) implementation.
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Data Standards Decisions - Home | datastandardsdecisions.com Reviews

https://datastandardsdecisions.com

Data Standards Decisions is a family owned company who specializes in data standards consultancy. Our lead consultant Gitte Frausing is an international recognized expert in the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data (CDISC SEND) model and Study Data Tabulation Model (SDTM) implementation.

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1

Data Standards Decisions - Home

http://www.datastandardsdecisions.com/home.html

7 July 2016 - SENDIG v. 3.1 is published! Note that the FDA adoption of SEND v. 3.1 is separate from the publication of the standard from CDISC. When they are ready, FDA will announce their support and requirements in the Data Standards Catalogue through a Federal Register Notice. 17 March 2016 - FDA support ends for Define.xml 1.0. 4 March 2016 - FDA review of Nonclinical Study Data Reviewer's Guide. You get the benefit of experience that's been acquired year after year, project after project. We get in...

2

About SEND

http://www.datastandardsdecisions.com/about-send.html

SEND is an abbreviation for Standard for Exchange of Nonclinical Data. Very briefly, it describes a structured way of compiling data collected in nonclinical (animal) studies for exchange between IT systems. In addition to the structure, SEND also comes with defined terminology for a number of standard endpoints and results. By using the same way of structuring data. You can read more about CDISC and SEND here:. CDISC Vision and Mission. Regarding requirements to electronic submissions. Means that requir...

3

Data Standards Decisions - Services

http://www.datastandardsdecisions.com/services.html

From ad hoc consultancy on an hourly basis to long term commitments, we will assist you in making informed decisions about. Data mapping and conversions. Data Management Processes and SOPs. A nonclinical Data Managers role and responsibilities. Data standard implementation approach. Aligning nonclinical study conduct and data collection to a semi-automated, structured electronic data management. Data standards and terminology transitions between versions. Regulatory submissions and feedback responses.

4

Data Standards Decicions - What We Do

http://www.datastandardsdecisions.com/what-we-do.html

Our vision, mission and values define the essence of who we are, how we work and interact with every client. We attract, recruit, and retain the most knowledgeable and passionate professionals, and we provide a collaborative culture that enables them to thrive professionally and personally. We believe that every new project is the foundation of a long-term client relationship, so every commitment will be given the same attention, high quality and diligence.

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Data Standards Decisions - Home

August 2017 - FDA announced their support and requirement start dates for SEND v. 3.1. On August 21, 2017, a Federal Register Notice announced FDA's support for SEND v. 3.1 and the requirement start dates for NDAs (15 March 2019) and for INDs (15 March 2020). The FDA Data Standards Catalogue can be accessed from here. For a little more guidance on the implications, you can find some help for interpreting the Data Standards Catalogue here. Open it as a pdf). July 2016 - SENDIG v. 3.1 is published! Data St...

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