Overview

Clinical study data is the information about a subject who participated in a clinical trial. It includes demographic information, details of medical treatment, descriptions of the participant’s progress, and other relevant information. Nonclinical data is the information received from the animal experiments in the pre-clinical phase of a study.. Studies suggest certain standardized methods to successfully exchange clinical and nonclinical research data between computer systems.

The United States Food and Drug Administration (FDA) may refuse to file New Drug Applications (NDA) and Biological License Applications (BLAs). It may refuse to receive Abbreviated New Drug Application (ANDA) if the study data submitted to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) is not on par with the data standards. As part of a collaborative effort between the FDA and the nonprofit Clinical Data Interchange Standards Consortium (CDISC), the following study data standards have been developed:   

  • 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
  • FDA is supporting efforts to develop clinical terminology standards for particular therapeutic areas within SDTM.
  • SDTM will be updated periodically to include new and revised standards for specific therapeutic areas.

For effective legacy conversions and study data analysis, Freyr helps organizations navigate end-to-end publishing and submissions. 

 

Freyr Expertise

  • Enhanced innovation
  • Facilitated data sharing
  • Maximizing the value of clinical study data
  • Complete traceability
  • Improved data quality
  • Streamlined processes 
 

Freyr Advantages

  • Fostered efficiency
  • Faster FDA submissions
  • Reducing the CDISC conversions-cycle time and costs
 

Freyr SUBMIT PRO

For faster, compliant and seamless submissions, Freyr offers an in-house eCTD tool Freyr SUBMIT PRO. Freyr SUBMIT PRO suits all your submission requirements across the globe and supports regional formats. To know more about Freyr SUBMIT PRO, gain a comprehensive overview at:

www.ectdtool.com