Save the Date! New FDA Requirements for Standardized Study Data

Save the Date! New FDA Requirements for Standardized Study Data
 

The FDA guidance, Providing Regulatory Submissions in Electronic Format — Standardized Study Data, states that all submissions for studies started after December 17, 2016 will require CDISC compliance.

Save the date!

SDTM, ADaM and Define-XML will be the only supported formats for all clinical data submitted to the FDA.

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To ensure your standards are successfully adopted in every phase of your drug development program, we provide:

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Clinical Data Acquisition Standards Harmonization (CDASH) compliant CRFs for paper-based clinical trials and eCRFs for electronic data capture (EDC) clinical trials, in their proper design format

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Study Data Tabulation Model (SDTM) compliant datasets for your ongoing trials and the migration to submission-ready format for your legacy study datasets for your legacy study data and the migration to submission-ready format of data from ongoing trials

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Analysis Data Model (ADaM) compliant datasets for statistical analysis

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With well over a decade of experience, our team of Biostatisticians, SAS Programmers and Data Managers provide high quality data with a personalized approach.

Are you ready?

 
 
CONTACT US TO SEE HOW WE CAN HELP!