CDISC Legacy Data Conversions

Freyr supports organizations with end-to-end publishing and submissions, ensuring effective CDISC legacy data conversions and adherence to study data standards, including CDISC SEND, SDTM, ADaM, and Define-XML, for Regulatory compliance with the FDA.

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CDISC Legacy Data Conversions - Overview

Study data is information about a person in a clinical trial. It includes demographic information, details of the medical treatment, descriptions of the participant's progress, and other relevant information. If the same attribute information is captured for animals, it is considered non-clinical data. Studies suggest that certain standard methods are ideal for the exchange of clinical and non-clinical research data among computer systems. The United States Food and Drug Administration (FDA) may refuse to file New Drug Applications (NDA) or Biological License Applications (BLAs) and may refuse to receive Abbreviated New Drug Applications (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 for effective legacy data conversions:

  • CDISC Legacy Data Conversions Standard for Exchange of Nonclinical Data (SEND) for nonclinical data.
  • CDISC Legacy Data Conversions Study Data Tabulation Model (SDTM) for clinical data standards.
  • CDISC Legacy Data Conversions Analysis Data Model (ADaM) for analysis of clinical data standards.
  • CDISC Legacy Data Conversions Case Report Tabulation Data Definition Specification (Define-XML) for the metadata that accompanies SEND, SDTM, and ADaM datasets.
  • The FDA is supporting efforts to develop clinical terminology standards for therapeutic areas within the SDTM.
  • SDTM will be updated periodically to include new and revised standards for specific therapeutic areas.

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

CDISC Legacy Data Conversions

  • Enhanced innovation.
  • Facilitated data sharing for legacy data conversions.
  • Maximizing the value of clinical study data.
  • Complete traceability.
  • Improved data quality.
  • Streamlined processes.
  • Fostered efficiency.
  • Faster FDA submissions.
  • Reducing the CDISC legacy data conversions-cycle-times and costs.

Unlock the Power of Standardized Legacy Data Conversions

Partnering with Leading Organizations

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​