SEND Intelligence Services enable companies to automate the transformation of raw data files of preclinical research and the production of SEND IG v3.1 data sets without any need for the acquisition of a new system or increased staffing. Xybion’s Savante® is one of the first on the market to achieve full compliance with SEND IG v3.1 with a validated solution.
SEND is a standard for the collection and formatting of nonclinical data so that it may be included in preclinical data submission to the FDA and other regulatory bodies that adopt the standard. By standardizing the format in which the data is submitted, SEND naturally impacts data collection and aggregation by harmonizing study designs and normalizing the terminologies used by scientists today. This homogenization of the preclinical data facilitates and leads to efficiencies on the part of the reviewers, accelerating the regulatory review process for NDA, ANDA, IND and certain BLA submissions.
Importantly, with the standardization of data formats and the normalization of the terminologies used in the dataset, the SEND standard also provides a long-sought transport mechanism by which CRO’s may transmit data to their Pharmaceutical clients for purposes other than submissions, such as data analyses and data mining.