CDISC Compliant Submission Deliverables

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Study data standards help teams share clinical and nonclinical research data. Sponsors implement these standards to share data with CROs, development partners, and agency reviewers. Health authorities use them to facilitate regulatory reviews of nonclinical and clinical trial data. The standards enable automations that improve the efficiency of regulatory reviews.  

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The US FDA has mandated electronic data standards for nonclinical and clinical data to be submitted to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) for Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologic License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs). These standards include:

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• CDISC Standard for Exchange of Nonclinical Data (SEND) for nonclinical data

• CDISC Study Data Tabulation Model (SDTM) for clinical data

• CDISC Analysis Data Model (ADaM) for analysis of clinical data

• CDISC Case Report Tabulation Data Definition Specification (Define-XML) for the metadata that accompanies SEND, SDTM, and ADaM datasets

 

Today, these standards are also required by Japan’s PMDA and preferred by China’s NMPA. Regulatory submissions represent years of research and millions of dollars worth of time and effort. Timelines are often tight, but compliance cannot be sacrificed for speed. Non-compliance can result in a technical rejection of the regulatory application. This can delay the start of new trials, pause agency review processes, and potentially risk product launch dates. 

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Most large and mid-size pharmaceutical and biotech companies and CROs have embraced the use of data standards and are employing them throughout the organization. As early-stage companies move their products through development, the standards facilitate due diligence activities with potential partners or acquirers, enabling quicker reviews and creating greater value for all stakeholders.

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TradeCraft understands the value of your data. We have extensive practical knowledge and experience creating CDISC compliant submission deliverables. We work closely with customer teams to ensure that all data deliverables reflect the hard work, effort, and investment that R&D organizations have put into their data.

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We produce regulatory submission data deliverables from INDs to NDAs, including:

• SEND

• SDTM Domains

• ADaM Analysis Datasets

• SDTM/ADAM QA Review of case report tabulation packages

• Define.pdf and Define.xml

• Study Data Reviewer’s Guide (SDRG)

• Study Data Standardization Plan (SDSP)

• Analysis Data Reviewer’s Guide

• Tables, Listings, and Figures

• ​Bioresearch Monitoring (BIMO) data package including:
  •    Subject-Level Data Line Listings by Clinical Site
       o    Individual Subject Listings by Site
  •    Summary Level Clinical Site Datasets
      o    Clinsite.xpt
      o    Define.xml
  •    Optional 

           o    Data Reviewer’s Guide  

We also offer CDISC mapping and conversion services for legacy data.

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