"Streamline Non-Clinical Regulatory Submissions with SEND Expertise"
SEND (Standard for Exchange of Nonclinical Data) is a standardized digital format for presenting nonclinical data to the FDA. It improves the efficiency of data review by replacing PDF study reports with a consistent format. Compliance with SEND is required for data submission to the FDA, ensuring data consistency and facilitating the regulatory process.
EPDA offers specialized SEND generation services to support sponsors and CROs in meeting FDA requirements for nonclinical data submission.
With expertise in extracting and validating data from various sources, including LIMS and study reports, EPDA ensures compliance with CDISC standards and FDA validation rules.
SEND is an CDISC FDA standard data format/terminology that is now required for submission of preclinical study data to the FDA. SEND specifies a way to collect and present nonclinical data in a consistent format.
- Discrepancy management
- SEND Standardized datasets in XPT format
- Define.XML package compliant with CDISC Standards.
- Non-Clinical Study Data Reviewer’s Guide (nSDRG)
- P-21 validation reports
Softwares : (Click Individual to know more)
