CDISC-SEND COMPLIANT DATA REPOSITORY, ANALYTICS AND REPORTS
The CDISC SEND model is an implementation of the Study Data Tabulation Model (SDTM) for the submission of nonclinical studies. The SEND Model was first developed in 2002, utilizing sections described in the CDER 1999 Guidance and the SDTM as its basis. The first pilot with the FDA was conducted in 2003, and since that time, more than forty volunteers representing pharmaceutical companies, vendors, and CROs have created close to thirty domains for general toxicology and pharmacology, carcinogenicity, and reproductive toxicology studies. The Food and Drug Administration (FDA) is widely expected make the SEND format mandatory for nonclinical submission packages within the next two years.
As a result, organizations performing nonclinical research are increasing looking for robust, sustainable solutions for the capture, aggregation, and formatting of nonclinical data in a SEND-compliant format. As the CDISC-SEND standards evolve, this has great impact on the IT systems used to support SEND-compliant data repositories. It is important to have a vendor with a long term commitment in this space with the knowledge and subject matter expertise necessary to help you create a lasting solution.With employees who participate in the CDISC community on an on-going basis, Xybion has been involved with the CDISC SEND initiative since 2003. Our professional technical staff has first-hand experience in contributing to the development of the finer details of the CDISC-SEND standards, together with colleagues from across the industry.
Xybion Solutions for CDISC-SEND Compliant Submissions
Xybion offers comprehensive solutions designed to meet all of your CDISC-SEND needs. From data capture, through data aggregation/formatting and analytics, Xybion is the preferred partner for many of the leading preclinical research sponsors across the industry. Labwise- Xybion’s unique breakthrough business process management solution for laboratories – provides additional features to help companies manage and oversee critical business processes that produce and maintain SEND-compliant data sets.