Study Data, legacy conversions, CDISC, FDA, Publishing, Submissions

Study data is information about a person in a clinical trial. It includes demographic information, details of medical treatment, descriptions of the participant’s progress, and other relevant information. If the same attribute information is captured for animals, it is considered nonclinical data. To exchange clinical and nonclinical research data among computer systems, studies suggest certain standard methods. The United States Food and Drug Administration (FDA) may refuse to file New Drug Applications (NDA), Biological License Applications (BLAs) and 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 accompany 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